474 -- Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 | Poliscope

Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019

474

116th Congress

In Committee

Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019

Legislative Progress

✓

Introduced

2

Committee

3

Floor Vote

4

Other Chamber

5

Enacted

Introduced

February 13, 2019

Latest Action

February 13, 2019

Primary Sponsor

Ron WydenDemocratic(OR)

Momentum (last 30 days)

0

score

0 actions · 0 new cosponsors · 0 votes

Speed vs cohort

0pct

0d open

vs 5,086 other S bills in the 116th — cohort avg 30d

Summary

Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2019 This bill requires manufacturers of drugs with specified percentage increases in their wholesale costs to submit to the Centers for Medicare & Medicaid Services (CMS) written justification for certain increases in drug prices. The CMS shall publish each submission, together with an easily understandable summary, on its website. Certain proprietary information may be excluded from publication, as specified by the bill. A manufacturer that does not comply with the bill's requirements shall be subject to civil monetary penalties.

Lobbying filings that explicitly cite this bill (50)

These links require the bill number to appear in the filing's source-reported specific issue text. Client expenses and lobbying-firm income are separate disclosure fields.

Filing registrants (27)

TIBER CREEK GROUP (6)ALSTON & BIRD LLP (7)TARPLIN, DOWNS & YOUNG, LLC (4)FEROX STRATEGIES (9)CALMETTO MANAGEMENT GROUP (1)FAEGRE DRINKER BIDDLE & REATH LLP (2)AARP (5)ABBVIE, INC. (4)AMERICA'S HEALTH INSURANCE PLANS, INC. (AHIP) (4)AMGEN, INC. (2)

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ASSOCIATION FOR ACCESSIBLE MEDICINES (3)

Subjects (7)

Civil actions and liability

Corporate finance and management

Government information and archives

Inflation and prices

Marketing and advertising

Prescription drugs

Research and development

Actions (2)

February 13, 2019

Read twice and referred to the Committee on Finance.

February 13, 2019

Introduced in Senate

Committees

Committee	Chamber	Activity	Date
Finance Committee	Senate	Referred to	February 13, 2019

Text Versions

Version	Date	Links
Introduced in Senate	February 13, 2019	XML

Cosponsors (12)

Name	Party	State
Amy Klobuchar	Democratic	MN
Benjamin L. Cardin	Democratic	MD
Catherine Cortez Masto	Democratic	NV

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Sources: Congress.gov

BIOTECHNOLOGY INNOVATION ORGANIZATIONclient→BIOTECHNOLOGY INNOVATION ORGANIZATION

2020 · second_quarter · Health Issues

Open original LDA filing ↗

Cited source text, amounts, lobbyists, and targets

21st Century Cures Act 2.0 ---RFI from House Energy and Commerce Committee 340B Drug Discount Program ---340B Pause Act (Discussion Draft House/Senate) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Nonfunding) ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Executive Order on Modernizing Influenza Vaccines ---Gene editing ---Implementation of 21st Century Cures Act of 2016 ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---National Biodefense Strategy ---Tropical Disease Priority Review Voucher (PRV) Program Biosimilars ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---Biosimilar Copay ---Brazil Biologics Regulations ---BSUFA ---Canada Biologics Regulations ---Coding ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 ---Implementation of CREATES Act of 2019 ---India Biologics Regulations ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---Reimbursement Climate Change ---RFI from House Select Committee on the Climate Crisis Coronavirus (COVID-19) Pandemic ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019 ---H.R.6206: Pandemic Response and Emergency Preparedness (PREP) Act of 2020 ---H.R.6260/S.3545: Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavirus Patients Act of 2020 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---COVID-19 Vaccine and Therapeutic Development ---Drug Supply Chain Management ---Healthcare Disparities ---Home Administration of Part B Drugs ---Liability ---Medicare reimbursement policies ---Patient Cost-Sharing and Smoothing ---Pricing-related Provisions ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Senate HELP Pandemic Preparedness White Paper Drug Evaluation and Review ---S.1617: Second Look at Drug Patents Act of 2019 ---S.3872: Promising Pathway Act ---Compassionate Use/Expanded Access ---Expedited Pathways ---Priority Review Voucher Programs Drug Manufacturing, Quality & Distribution ---Drug Shortages ---Drug Supply Chain Management Drug Patenting ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 Drug Pricing ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1093/S.378: Stop Price Gouging Act of 2019 ---H.R.1425: The Patient Protection and Affordable Care Enhancement Act of 2020 ---H.R.2069/S.474: Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 ---H.R.2113: Prescription Drug STAR Act of 2019 ---H.R.2376/S.1227: Prescription Pricing for the People Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---CMMI Authority ---General ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Implementation of CREATES Act of 2019 ---International Pricing Index Proposal ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Potential Administration Executive Orders ---Pricing-related Provisions Foreign Drug Data Protection Laws ---Regulatory Harmonization Funding for Antimicrobial Resistance Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Health Defense Operations Funding Designation ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for FDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 Funding for Health Resources and Services Administration (HRSA) - Vaccine Injury Compensation Program (VICP) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for National Institutes of Health ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Funding for 2020-21 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Medicaid ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Alternative payment arrangements for gene therapies ---Average Manufacturer Price Calculations ---Pricing and Rebates Medicare Expansion ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 Orphan Drug Issues ---H.R.4439/S.4010: Creating Hope Reauthorization Act of 2019 ---H.R.4712: Fairness in Orphan Drug Exclusivity Act of 2019 ---Tax Credit Rare Pediatric Disease Priority Review ---H.R.4439/S.4010: Creating Hope Reauthorization Act of 2019 Reimbursement and Coverage of Innovative Products ---H.R.275: Medicare Prescription Drug Price Negotiation Act of 2019 ---H.R.5122: To prohibit further action on the proposed rule regarding testing of Medicare Part B Prescription Drug Models ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---S.2326: New Opportunities for Value that Extend Lives (NOVEL) Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Administration Rebate Rule ---CMMI Authority ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Home Administration of Part B Drugs ---International Pricing Index Proposal ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Surprise Billing ---Value-based Contracting and Communications The United States-Mexico-Canada Agreement (USMCA) ---Implementation of United States-Mexico-Canada Agreement (USMCA) ---IP Provisions Trade and Foreign Drug Price Controls US-China Trade Agreement ---IP Provisions US-EU Trade Agreement ---IP Provisions US-Japan Trade Agreement ---IP Provisions US-Kenya Trade Agreement ---IP Provisions US-UK Trade Agreement ---IP Provisions Vaccines and Infectious Diseases ---H.R.2862/S.1619: Vaccine Awareness Campaign to Champion Immunization Nationally and Enhance Safety (VACCINES) Act of 2019 ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Adult Immunization Education ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Maternal Immunization ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program

Client expense: $3,320,000 · Firm income: Not reported

S.474

ANDREW CONNER CLAIRE BRANDEWIE DAVID LACHMANN HAYLEY ALEXANDER JAMIE GREGORIAN JEANNE HAGGERTY JOHN MURPHY JOSEPH DAMOND MICHAEL MATTOON PHYLLIS ARTHUR SHEA HARTLEY mr MATTHEW O'MARA ms AIKEN HACKETT ms ELIZABETH ESHAM

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Security Council (NSC), Office of the Vice President of the United States, SENATE, U.S. Trade Representative (USTR), White House Office

BIOTECHNOLOGY INNOVATION ORGANIZATIONclient→BIOTECHNOLOGY INNOVATION ORGANIZATION

2020 · second_quarter · Health Issues

Open original LDA filing ↗

Cited source text, amounts, lobbyists, and targets

21st Century Cures Act 2.0 ---RFI from House Energy and Commerce Committee 340B Drug Discount Program ---340B Pause Act (Discussion Draft House/Senate) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Nonfunding) ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Executive Order on Modernizing Influenza Vaccines ---Gene editing ---Implementation of 21st Century Cures Act of 2016 ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---National Biodefense Strategy ---Tropical Disease Priority Review Voucher (PRV) Program Biosimilars ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---Biosimilar Copay ---Brazil Biologics Regulations ---BSUFA ---Canada Biologics Regulations ---Coding ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 ---Implementation of CREATES Act of 2019 ---India Biologics Regulations ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---Reimbursement Climate Change ---RFI from House Select Committee on the Climate Crisis Coronavirus (COVID-19) Pandemic ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019 ---H.R.6206: Pandemic Response and Emergency Preparedness (PREP) Act of 2020 ---H.R.6260/S.3545: Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavirus Patients Act of 2020 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---COVID-19 Vaccine and Therapeutic Development ---Drug Supply Chain Management ---Healthcare Disparities ---Home Administration of Part B Drugs ---Liability ---Medicare reimbursement policies ---Patient Cost-Sharing and Smoothing ---Pricing-related Provisions ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Senate HELP Pandemic Preparedness White Paper Drug Evaluation and Review ---S.1617: Second Look at Drug Patents Act of 2019 ---S.3872: Promising Pathway Act ---Compassionate Use/Expanded Access ---Expedited Pathways ---Priority Review Voucher Programs Drug Manufacturing, Quality & Distribution ---Drug Shortages ---Drug Supply Chain Management Drug Patenting ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 Drug Pricing ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1093/S.378: Stop Price Gouging Act of 2019 ---H.R.1425: The Patient Protection and Affordable Care Enhancement Act of 2020 ---H.R.2069/S.474: Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 ---H.R.2113: Prescription Drug STAR Act of 2019 ---H.R.2376/S.1227: Prescription Pricing for the People Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---CMMI Authority ---General ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Implementation of CREATES Act of 2019 ---International Pricing Index Proposal ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Potential Administration Executive Orders ---Pricing-related Provisions Foreign Drug Data Protection Laws ---Regulatory Harmonization Funding for Antimicrobial Resistance Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Health Defense Operations Funding Designation ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for FDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 Funding for Health Resources and Services Administration (HRSA) - Vaccine Injury Compensation Program (VICP) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for National Institutes of Health ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Funding for 2020-21 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Medicaid ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Alternative payment arrangements for gene therapies ---Average Manufacturer Price Calculations ---Pricing and Rebates Medicare Expansion ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 Orphan Drug Issues ---H.R.4439/S.4010: Creating Hope Reauthorization Act of 2019 ---H.R.4712: Fairness in Orphan Drug Exclusivity Act of 2019 ---Tax Credit Rare Pediatric Disease Priority Review ---H.R.4439/S.4010: Creating Hope Reauthorization Act of 2019 Reimbursement and Coverage of Innovative Products ---H.R.275: Medicare Prescription Drug Price Negotiation Act of 2019 ---H.R.5122: To prohibit further action on the proposed rule regarding testing of Medicare Part B Prescription Drug Models ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---S.2326: New Opportunities for Value that Extend Lives (NOVEL) Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Administration Rebate Rule ---CMMI Authority ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Home Administration of Part B Drugs ---International Pricing Index Proposal ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Surprise Billing ---Value-based Contracting and Communications The United States-Mexico-Canada Agreement (USMCA) ---Implementation of United States-Mexico-Canada Agreement (USMCA) ---IP Provisions Trade and Foreign Drug Price Controls US-China Trade Agreement ---IP Provisions US-EU Trade Agreement ---IP Provisions US-Japan Trade Agreement ---IP Provisions US-Kenya Trade Agreement ---IP Provisions US-UK Trade Agreement ---IP Provisions Vaccines and Infectious Diseases ---H.R.2862/S.1619: Vaccine Awareness Campaign to Champion Immunization Nationally and Enhance Safety (VACCINES) Act of 2019 ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Adult Immunization Education ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Maternal Immunization ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program

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2020 · third_quarter · Medicare/Medicaid

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Cited source text, amounts, lobbyists, and targets

H.R. 107, Burgess: Rebate cap, regarding all bio-pharmaceutical related provisions. H.R. 275, Medicare Prescription Drug Negotiation Act, regarding all bio-pharmaceutical related provisions. H.R. 366, Insulin Access for All Act, regarding all bio-pharmaceutical related provisions. H.R. 1034, D. Collins/S. 640, Kennedy: Phair Pricing Act - Share the savings, regarding all bio-pharmaceutical related provisions. H.R. 1035, Prescription Drug Price Transparency Act, regarding all bio-pharmaceutical related provisions. H.R. 1332, Fair Care Act, regarding all bio-pharmaceutical related provisions. H.R. 1346, Medicare Buy-In and Health Care Stabilization Act, regarding all bio-pharmaceutical related provisions. H.R. 1384, Medicare for All Act, regarding all bio-pharmaceutical related provisions. H.R. 1781, Payment Commission Data Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 1788, Limits the penalty for Part B late enrollment to 15 percent and twice the period of no enrollment, regarding all bio-pharmaceutical related provisions. H.R. 2087, Reporting drug pricing information to Medicare, regarding all bio-pharmaceutical related provisions. H.R. 2113, Prescription STAR Act, regarding all bio-pharmaceutical related provisions. H.R.3, Lower Drug Costs Now Act of 2019, regarding all bio-pharmaceutical related provisions S. 62, Empowering Medicare Seniors to Negotiate Drug Prices, regarding all bio-pharmaceutical related provisions. S. 99, Medicare Drug Price Negotiation Act, regarding all bio-pharmaceutical related provisions. S. 205, Right Rebate Act, regarding all bio-pharmaceutical related provisions. S. 377/H.R. 1046, Medicare Negotiation and Competitive Licensing Act, regarding all bio-pharmaceutical related provisions. S. 470, Medicare at 50 Act, regarding all bio-pharmaceutical related provisions. S. 474, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 , regarding all bio-pharmaceutical related provisions. S. 475, RxCAP Act, regarding all bio-pharmaceutical related provisions. S. 476, Creating Transparency to Have Drug Rebates Unlocked (C-THRU Act) of 2019, regarding all bio-pharmaceutical related provisions. S. 551, REFUND Act of 2019, regarding all bio-pharmaceutical related provisions. S. 691, Expands Part D OOP assistance for low-income seniors and individuals with disabilities, regarding all bio-pharmaceutical related provisions. S. 801/H.R. 1781, Allows MedPAC and MACPAC to have access to information on drug rebates, regarding all bio-pharmaceutical related provisions. S. 981, Medicare-X Choice Act of 2019, regarding all bio-pharmaceutical related provisions. Pending rule to change the Rebate Safe Harbor, regarding all bio-pharmaceutical related provisions. H.R. 1839, Medicaid Services Investment and Accountability Act, regarding all bio-pharmaceutical related provisions H.R. 2452, Medicare for America Act, regarding all bio-pharmaceutical related provisions H.R. 3107, Improving Seniors Timely Access to Care Act, regarding all bio-pharmaceutical related provisions H.R. 3327, Drug Price Transparency for Medicare Patients Act, regarding all bio-pharmaceutical related provisions S. 1261/H.R. 2463, Choose Medicare Act, regarding all bio-pharmaceutical related provisions S. 1497, Health Care Price Check Act, regarding all bio-pharmaceutical related provisions S. 2081, a bill to require drug manufacturers to provide rebates for drugs furnished under Medicare Part B for which the growth in average sales price has exceeded inflation, regarding all bio-pharmaceutical related provisions. S. 2543, Prescription Drug Pricing Reduction Act of 2019, regarding all bio-pharmaceutical provisions. H.R. 19/S.3129 , Lower Costs, More Cures Act of 2019, regarding all bio-pharmaceutical related provisions H.R. 6218/S. 3457, Preserving Patient Access to Home Infusion Act, regarding all bio-pharmaceutical related provisions No Bill, Reimbursement for and patient access to Chimeric Antigen Receptor (CAR) T-cell therapies.

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2020 · second_quarter · Medicare/Medicaid

Open original LDA filing ↗

Cited source text, amounts, lobbyists, and targets

H.R. 107, Burgess: Rebate cap, regarding all bio-pharmaceutical related provisions. H.R. 275, Medicare Prescription Drug Negotiation Act, regarding all bio-pharmaceutical related provisions. H.R. 366, Insulin Access for All Act, regarding all bio-pharmaceutical related provisions. H.R. 1034, D. Collins/S. 640, Kennedy: Phair Pricing Act - Share the savings, regarding all bio-pharmaceutical related provisions. H.R. 1035, Prescription Drug Price Transparency Act, regarding all bio-pharmaceutical related provisions. H.R. 1332, Fair Care Act, regarding all bio-pharmaceutical related provisions. H.R. 1346, Medicare Buy-In and Health Care Stabilization Act, regarding all bio-pharmaceutical related provisions. H.R. 1384, Medicare for All Act, regarding all bio-pharmaceutical related provisions. H.R. 1781, Payment Commission Data Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 1788, Limits the penalty for Part B late enrollment to 15 percent and twice the period of no enrollment, regarding all bio-pharmaceutical related provisions. H.R. 2087, Reporting drug pricing information to Medicare, regarding all bio-pharmaceutical related provisions. H.R. 2113, Prescription STAR Act, regarding all bio-pharmaceutical related provisions. H.R.3, Lower Drug Costs Now Act of 2019, regarding all bio-pharmaceutical related provisions S. 62, Empowering Medicare Seniors to Negotiate Drug Prices, regarding all bio-pharmaceutical related provisions. S. 99, Medicare Drug Price Negotiation Act, regarding all bio-pharmaceutical related provisions. S. 205, Right Rebate Act, regarding all bio-pharmaceutical related provisions. S. 377/H.R. 1046, Medicare Negotiation and Competitive Licensing Act, regarding all bio-pharmaceutical related provisions. S. 470, Medicare at 50 Act, regarding all bio-pharmaceutical related provisions. S. 474, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 , regarding all bio-pharmaceutical related provisions. S. 475, RxCAP Act, regarding all bio-pharmaceutical related provisions. S. 476, Creating Transparency to Have Drug Rebates Unlocked (C-THRU Act) of 2019, regarding all bio-pharmaceutical related provisions. S. 551, REFUND Act of 2019, regarding all bio-pharmaceutical related provisions. S. 691, Expands Part D OOP assistance for low-income seniors and individuals with disabilities, regarding all bio-pharmaceutical related provisions. S. 801/H.R. 1781, Allows MedPAC and MACPAC to have access to information on drug rebates, regarding all bio-pharmaceutical related provisions. S. 981, Medicare-X Choice Act of 2019, regarding all bio-pharmaceutical related provisions. Pending rule to change the Rebate Safe Harbor, regarding all bio-pharmaceutical related provisions. H.R. 1839, Medicaid Services Investment and Accountability Act, regarding all bio-pharmaceutical related provisions H.R. 2452, Medicare for America Act, regarding all bio-pharmaceutical related provisions H.R. 3107, Improving Seniors Timely Access to Care Act, regarding all bio-pharmaceutical related provisions H.R. 3327, Drug Price Transparency for Medicare Patients Act, regarding all bio-pharmaceutical related provisions S. 1261/H.R. 2463, Choose Medicare Act, regarding all bio-pharmaceutical related provisions S. 1497, Health Care Price Check Act, regarding all bio-pharmaceutical related provisions S. 2081, a bill to require drug manufacturers to provide rebates for drugs furnished under Medicare Part B for which the growth in average sales price has exceeded inflation, regarding all bio-pharmaceutical related provisions. S. 2543, Prescription Drug Pricing Reduction Act of 2019, regarding all bio-pharmaceutical provisions. H.R. 19/S.3129 , Lower Costs, More Cures Act of 2019, regarding all bio-pharmaceutical related provisions H.R. 6218/S. 3457, Preserving Patient Access to Home Infusion Act, regarding all bio-pharmaceutical related provisions No Bill, Reimbursement for and patient access to Chimeric Antigen Receptor (CAR) T-cell therapies.

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2020 · fourth_quarter · Medicare/Medicaid

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Cited source text, amounts, lobbyists, and targets

H.R. 107, Burgess: Rebate cap, regarding all bio-pharmaceutical related provisions. H.R. 275, Medicare Prescription Drug Negotiation Act, regarding all bio-pharmaceutical related provisions. H.R. 366, Insulin Access for All Act, regarding all bio-pharmaceutical related provisions. H.R. 1034, D. Collins/S. 640, Kennedy: Phair Pricing Act - Share the savings, regarding all bio-pharmaceutical related provisions. H.R. 1035, Prescription Drug Price Transparency Act, regarding all bio-pharmaceutical related provisions. H.R. 1332, Fair Care Act, regarding all bio-pharmaceutical related provisions. H.R. 1346, Medicare Buy-In and Health Care Stabilization Act, regarding all bio-pharmaceutical related provisions. H.R. 1384, Medicare for All Act, regarding all bio-pharmaceutical related provisions. H.R. 1781, Payment Commission Data Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 1788, Limits the penalty for Part B late enrollment to 15 percent and twice the period of no enrollment, regarding all bio-pharmaceutical related provisions. H.R. 2087, Reporting drug pricing information to Medicare, regarding all bio-pharmaceutical related provisions. H.R. 2113, Prescription STAR Act, regarding all bio-pharmaceutical related provisions. H.R.3, Lower Drug Costs Now Act of 2019, regarding all bio-pharmaceutical related provisions S. 62, Empowering Medicare Seniors to Negotiate Drug Prices, regarding all bio-pharmaceutical related provisions. S. 99, Medicare Drug Price Negotiation Act, regarding all bio-pharmaceutical related provisions. S. 205, Right Rebate Act, regarding all bio-pharmaceutical related provisions. S. 377/H.R. 1046, Medicare Negotiation and Competitive Licensing Act, regarding all bio-pharmaceutical related provisions. S. 470, Medicare at 50 Act, regarding all bio-pharmaceutical related provisions. S. 474, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 , regarding all bio-pharmaceutical related provisions. S. 475, RxCAP Act, regarding all bio-pharmaceutical related provisions. S. 476, Creating Transparency to Have Drug Rebates Unlocked (C-THRU Act) of 2019, regarding all bio-pharmaceutical related provisions. S. 551, REFUND Act of 2019, regarding all bio-pharmaceutical related provisions. S. 691, Expands Part D OOP assistance for low-income seniors and individuals with disabilities, regarding all bio-pharmaceutical related provisions. S. 801/H.R. 1781, Allows MedPAC and MACPAC to have access to information on drug rebates, regarding all bio-pharmaceutical related provisions. S. 981, Medicare-X Choice Act of 2019, regarding all bio-pharmaceutical related provisions. Pending rule to change the Rebate Safe Harbor, regarding all bio-pharmaceutical related provisions. H.R. 1839, Medicaid Services Investment and Accountability Act, regarding all bio-pharmaceutical related provisions H.R. 2452, Medicare for America Act, regarding all bio-pharmaceutical related provisions H.R. 3107, Improving Seniors Timely Access to Care Act, regarding all bio-pharmaceutical related provisions H.R. 3327, Drug Price Transparency for Medicare Patients Act, regarding all bio-pharmaceutical related provisions S. 1261/H.R. 2463, Choose Medicare Act, regarding all bio-pharmaceutical related provisions S. 1497, Health Care Price Check Act, regarding all bio-pharmaceutical related provisions S. 2081, a bill to require drug manufacturers to provide rebates for drugs furnished under Medicare Part B for which the growth in average sales price has exceeded inflation, regarding all bio-pharmaceutical related provisions. S. 2543, Prescription Drug Pricing Reduction Act of 2019, regarding all bio-pharmaceutical provisions. H.R. 19/S.3129 , Lower Costs, More Cures Act of 2019, regarding all bio-pharmaceutical related provisions H.R. 6218/S. 3457, Preserving Patient Access to Home Infusion Act, regarding all bio-pharmaceutical related provisions No Bill, Reimbursement for and patient access to Chimeric Antigen Receptor (CAR) T-cell therapies. Most Favored Nation (MFN) Model - (CMS-5528-IFC)

NATIONAL COMMUNITY PHARMACISTS ASSOCIATIONclient→NATIONAL COMMUNITY PHARMACISTS ASSOCIATION

2020 · fourth_quarter · Health Issues

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Cited source text, amounts, lobbyists, and targets

S. 474, Stop the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act; H.R. 447 / S. 97, Affordable and Safe Prescription Drug Importation Act; S. 61 / H.R. 478, Safe and Affordable Drugs from Canada Act of 2019; S. 102 / H.R. 465, Prescription Drug Price Relief Act of 2019; H.R.1478, Affordable Insulin Act of 2019; S. 3, Keeping Health Insurance Affordable Act of 2019; H.R 965 / S. 340, CREATES Act of 2019; H.R. 1332, Fair Care Act of 2019; S. 637, CURE High Drug Prices Act; H.R. 1499, Protecting Consumer Access to Generic Drugs Act of 2019; S. 657, A bill to amend title XXVII of the Public Health Service Act to establish requirements with respect to prescription drug benefits; S. 709, Prescription Drug Pricing Dashboard Act; S. 977, Transparent Drug Pricing Act of 2019; S. 1895, Lower Health Care Costs Act; H.R. 2296, FAIR Drug Pricing Act of 2019; H.R. 3947, the Competition Prescription Act of 2019; H.R. 2279, the Safe Step Act; H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act; S. 2543, the Prescription Drug Pricing Reduction Act of 2019; H.R. 19 / S. 3129, the Lower Costs, More Cures Act of 2019; S. 4199, the Prescription Drug Pricing Reduction Act of 2020

Client expense: $330,000 · Firm income: Not reported

S. 474

ANNE CASSITY KARRY LA VIOLETTE PHILLIP HARBISON RONNA HAUSER

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), SENATE, Small Business Administration (SBA), Substance Abuse & Mental Health Services Administration (SAMHSA), White House Office

BRISTOL-MYERS SQUIBB COMPANYclient→BRISTOL-MYERS SQUIBB COMPANY

2020 · fourth_quarter · Medicare/Medicaid

Open original LDA filing ↗

Cited source text, amounts, lobbyists, and targets

H.R. 107, Burgess: Rebate cap, regarding all bio-pharmaceutical related provisions. H.R. 275, Medicare Prescription Drug Negotiation Act, regarding all bio-pharmaceutical related provisions. H.R. 366, Insulin Access for All Act, regarding all bio-pharmaceutical related provisions. H.R. 1034, D. Collins/S. 640, Kennedy: Phair Pricing Act - Share the savings, regarding all bio-pharmaceutical related provisions. H.R. 1035, Prescription Drug Price Transparency Act, regarding all bio-pharmaceutical related provisions. H.R. 1332, Fair Care Act, regarding all bio-pharmaceutical related provisions. H.R. 1346, Medicare Buy-In and Health Care Stabilization Act, regarding all bio-pharmaceutical related provisions. H.R. 1384, Medicare for All Act, regarding all bio-pharmaceutical related provisions. H.R. 1781, Payment Commission Data Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 1788, Limits the penalty for Part B late enrollment to 15 percent and twice the period of no enrollment, regarding all bio-pharmaceutical related provisions. H.R. 2087, Reporting drug pricing information to Medicare, regarding all bio-pharmaceutical related provisions. H.R. 2113, Prescription STAR Act, regarding all bio-pharmaceutical related provisions. H.R.3, Lower Drug Costs Now Act of 2019, regarding all bio-pharmaceutical related provisions S. 62, Empowering Medicare Seniors to Negotiate Drug Prices, regarding all bio-pharmaceutical related provisions. S. 99, Medicare Drug Price Negotiation Act, regarding all bio-pharmaceutical related provisions. S. 205, Right Rebate Act, regarding all bio-pharmaceutical related provisions. S. 377/H.R. 1046, Medicare Negotiation and Competitive Licensing Act, regarding all bio-pharmaceutical related provisions. S. 470, Medicare at 50 Act, regarding all bio-pharmaceutical related provisions. S. 474, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 , regarding all bio-pharmaceutical related provisions. S. 475, RxCAP Act, regarding all bio-pharmaceutical related provisions. S. 476, Creating Transparency to Have Drug Rebates Unlocked (C-THRU Act) of 2019, regarding all bio-pharmaceutical related provisions. S. 551, REFUND Act of 2019, regarding all bio-pharmaceutical related provisions. S. 691, Expands Part D OOP assistance for low-income seniors and individuals with disabilities, regarding all bio-pharmaceutical related provisions. S. 801/H.R. 1781, Allows MedPAC and MACPAC to have access to information on drug rebates, regarding all bio-pharmaceutical related provisions. S. 981, Medicare-X Choice Act of 2019, regarding all bio-pharmaceutical related provisions. Pending rule to change the Rebate Safe Harbor, regarding all bio-pharmaceutical related provisions. H.R. 1839, Medicaid Services Investment and Accountability Act, regarding all bio-pharmaceutical related provisions H.R. 2452, Medicare for America Act, regarding all bio-pharmaceutical related provisions H.R. 3107, Improving Seniors Timely Access to Care Act, regarding all bio-pharmaceutical related provisions H.R. 3327, Drug Price Transparency for Medicare Patients Act, regarding all bio-pharmaceutical related provisions S. 1261/H.R. 2463, Choose Medicare Act, regarding all bio-pharmaceutical related provisions S. 1497, Health Care Price Check Act, regarding all bio-pharmaceutical related provisions S. 2081, a bill to require drug manufacturers to provide rebates for drugs furnished under Medicare Part B for which the growth in average sales price has exceeded inflation, regarding all bio-pharmaceutical related provisions. S. 2543, Prescription Drug Pricing Reduction Act of 2019, regarding all bio-pharmaceutical provisions. H.R. 19/S.3129 , Lower Costs, More Cures Act of 2019, regarding all bio-pharmaceutical related provisions H.R. 6218/S. 3457, Preserving Patient Access to Home Infusion Act, regarding all bio-pharmaceutical related provisions No Bill, Reimbursement for and patient access to Chimeric Antigen Receptor (CAR) T-cell therapies. Most Favored Nation (MFN) Model - (CMS-5528-IFC)

Client expense: $1,090,000 · Firm income: Not reported

S. 474

CHRISTOPHER PERNIE GREG CHESMORE JOHN DEOUDES LANE PENRY THOMAS BRUNET mr PAUL WILLIAMS mr RICARDO SANCHEZ ORTEGON

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, U.S. Trade Representative (USTR)

BIOTECHNOLOGY INNOVATION ORGANIZATIONclient→BIOTECHNOLOGY INNOVATION ORGANIZATION

2020 · third_quarter · Health Issues

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Cited source text, amounts, lobbyists, and targets

H.R.34: 21st Century Cures Act 2.0 ---RFI from House Energy and Commerce Committee 340B Drug Discount Program ---Executive Order on Affordable Life-saving Medications ---H.R. 7614: Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Program Implementation & Oversight Reimbursement and Coverage of Innovative Products ---Executive order on Lowering Drug Prices by Putting America First Drug Importation ---Executive Order on Increasing Drug Importation to Lower Prices for American Patients Antibiotic & Diagnostic Tax Credit Asia Pacific Economic Cooperation Forum ---Biologics Regulations ---Intellectual Property Issues Biodefense Research, Development and Procurement Issues (Nonfunding) ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Families First Coronavirus Response Act of 2020 ---H.R. 748: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---H.R.4100/S.1712: DISARM Act of 2019 ---S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 ---S.4231: Preparing for the Next Pandemic Act of 2020 ---Strategic National Stockpile ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7537: Infectious Disease Therapies Research and Innovation Act ---H.R.7556: To amend the Internal Revenue Code of 1986 to make a portion of research credit refundable for certain small businesses engaging in specified medical research. ---H.R.7555: To amend the Internal Revenue Code of 1986 to add a new medical research component to the credit for increasing research activities. ---H.R.7537: Infectious Disease Therapies Research and Innovation Act ---Implementation of the Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Executive Order on Buy American ---Executive Order on Modernizing Influenza Vaccines ---Gene editing ---Implementation of 21st Century Cures Act of 2016 ---Implementation of Medical Countermeasure Innovation Act of 2016 ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---National Biodefense Strategy ---Senate HELP Pandemic Preparedness White Paper ---Tropical Disease Priority Review Voucher (PRV) Program Biosimilars ---Biosimilar Copay ---BSUFA ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 ---Reimbursement Climate Change ---RFI from House Select Committee on the Climate Crisis Coronavirus (COVID-19) Pandemic ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019 ---H.R.7917: IGNITE American Innovation Act ---H.R.6260/S.3545: Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavirus Patients Act of 2020 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---S.4775: The Delivering Immediate Relief to America's Families, Schools and Small Business Act ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---COVID-19 Vaccine and Therapeutic Development ---Coverage for Covid Tx ---Drug Supply Chain Management ---Funding for Countermeasure Injury Compensation Program ---Healthcare Disparities ---Home Administration of Part B Drugs ---Liability ---Medicare reimbursement policies ---Patient Cost-Sharing and Smoothing ---Pricing-related Provisions ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Senate HELP Pandemic Preparedness White Paper Drug Evaluation and Review ---S.1617: Second Look at Drug Patents Act of 2019 ---H.R.7269/S.3872: Promising Pathway Act ---Compassionate Use/Expanded Access ---Expedited Pathways ---Priority Review Voucher Programs Drug Manufacturing, Quality & Distribution ---Drug Shortages ---Drug Supply Chain Management ---Executive Order on Buy American Drug Patenting ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 Drug Pricing ---H.R.3: Lower Drug Costs Now Act of 2019 ---H.R.488/S.99: Medicare Drug Price Negotiation Act of 2019 ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1093/S.378: Stop Price Gouging Act of 2019 ---H.R.1425: The Patient Protection and Affordable Care Enhancement Act of 2020 ---S.1895: Lower Health Care Costs for Patients Act of 2019 ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---S.1617: Second Look at Drug Patents Act of 2019 ---H.R.19/S.3129: Lower Costs, More Cures Act of 2019 ---H.R.2069/S.474: Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 ---H.R.275: Medicare Prescription Drug Price Negotiation Act of 2019 ---H.R.1188/S.366: Forcing Limits on Abusive and Tumultuous prices (FLAT) prices Act of 2019 ---H.R.2113: Prescription Drug STAR Act of 2019 ---H.R.2376/S.1227: Prescription Pricing for the People Act of 2019 ---H.R.2387: Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon (STOP GAMES) Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---H.R.3199: Terminating the Extension of Rights Misappropriated (TERM) Act of 2019 ---H.R.3991: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 ---H.R.7614: Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---CMMI Authority ---Executive Order on Buy American ---Executive Order on Access to Affordable Life-saving Medications ---Executive Order on Increasing Drug Importation to Lower Prices for American Patients ---Executive Order on Lowering Prices for Patients by Eliminating Kickbacks to Middlemen ---General ---International Pricing Index Proposal ---Most Favored Nation Executive Order ---Proposed Federal Price Caps on COVID-19 Therapeutics and Vaccines Foreign Drug Data Protection Laws ---Regulatory Harmonization Funding for Antimicrobial Resistance Programs ---S. 1624: Health, Economic Assistance, Liability Protection, and Schools (HEALS) Act ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act of 2020 ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---H.R.7610: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---H.R.7614: Labor, Health and Human services, Education, and Related Agencies Appropriations Act for FY 2021 ---H.R.748: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---S.4760:Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 8337: Continuing Appropriations Act, 2021 and other Extensions Act of 2020 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act of 2020 ---H.R.748: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---H.R.7614: Labor, Health and Human services, Education, and Related Agencies Appropriations Act for FY 2021 ---S. 1624: Health, Economic Assistance, Liability Protection, and Schools (HEALS) Act ---Health Defense Operations Funding Designation ---H.R.7537: Infectious Disease Therapies Research and Innovation Act ---H.R.7556: To amend the Internal Revenue Code of 1986 to make a portion of research credit refundable for certain small businesses engaging in specified medical research. ---H.R.7555: To amend the Internal Revenue Code of 1986 to add a new medical research component to the credit for increasing research activities. ---H.R.7537: Infectious Disease Therapies Research and Innovation Act Funding for FDA ---H.R.7610: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 Funding for Health Resources and Services Administration (HRSA) - Vaccine Injury Compensation Program (VICP) ---H.R.7614: Labor, Health and Human services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for National Institutes of Health ---H.R. 8337: Continuing Appropriations Act, 2021 and other Extensions Act of 2020 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act of 2020 ---H.R.748: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 8337: Continuing Appropriations Act, 2021 and other Extensions Act of 2020 ---H.R.748: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act of 2020 ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---H.R.7614: Labor, Health and Human services, Education, and Related Agencies Appropriations Act for FY 2021 ---Funding for 2020-21 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---H.R.7614: Labor, Health and Human services, Education, and Related Agencies Appropriations Act for FY 2021 Medicaid ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---S.3013: Encouraging Innovation Benefit Design to Lower Costs for Seniors Act of 2019 ---Alternative payment arrangements for gene therapies ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Medicare Expansion ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 Orphan Drug Issues ---H.R.4439/S.4010: Creating Hope Reauthorization Act of 2019 ---H.R.4712: Fairness in Orphan Drug Exclusivity Act of 2019 ---Tax Credit Rare Pediatric Disease Priority Review ---H.R. 8337: Continuing Appropriations Act, 2021 and other Extensions Act of 2020 ---H.R.4439/S.4010: Creating Hope Reauthorization Act of 2019 Reimbursement and Coverage of Innovative Products ---H.R.19/S.3129: Lower Costs, More Cures Act of 2019 ---H.R.275: Medicare Prescription Drug Price Negotiation Act of 2019 ---H.R.3: Lower Drug Costs Now Act of 2019 ---H.R.488/S.99: Medicare Drug Price Negotiation Act of 2019 ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act of 2020 ---S.2326: New Opportunities for Value that Extend Lives (NOVEL) Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Administration Rebate Rule ---CMMI Authority ---Executive Order on Lowering Drug Prices by Putting America First ---Executive Order on Access to Affordable Life-Saving Medications ---Executive Order on Lowering Prices for Patients by Eliminating Kickbacks to Middlemen ---In-Home Administration of Part B Drugs ---International Pricing Index Proposal ---Medicare Part B Physician-Administered Products ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-Based Purchasing (VBP) Rule ---Value-based Contracting and Communications The United States-Mexico-Canada Agreement (USMCA) ---Implementation of United States-Mexico-Canada Agreement (USMCA) ---IP Provisions Trade and Foreign Drug Price Controls US-China Trade Agreement ---IP Provisions US-UK Trade Agreement ---Digital Trade ---IP Provisions ---Market Access ---Regulatory Harmonization Vaccines and Infectious Diseases ---H.R.2862/S.1619: Vaccine Awareness Campaign to Champion Immunization Nationally and Enhance Safety (VACCINES) Act of 2019 ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act of 2020 ---H.R.748: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---H.R.7614: Labor, Health and Human services, Education, and Related Agencies Appropriations Act for FY 2021 ---S.4509: Vaccine And Coverage Certainty (VACC) Act ---Adult Immunization Education ---Countermeasure Injury Compensation Program ---Implementation of the Families First Coronavirus Response Act of 2020 ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Maternal Immunization ---Operation Warp Speed/ACTIV ---S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine and Anti-Microbial Resistance Product Development and Incentives

Client expense: $3,170,000 · Firm income: Not reported

S.474

ANDREW CONNER CLAIRE BRANDEWIE DAVID LACHMANN HAYLEY ALEXANDER JAMIE GREGORIAN JEANNE HAGGERTY MICHAEL MATTOON PHYLLIS ARTHUR SHEA HARTLEY mr MATTHEW O'MARA ms AIKEN HACKETT ms ELIZABETH ESHAM

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Security Council (NSC), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

MERCK & CO., INC.client→MERCK & CO., INC.

2020 · third_quarter · Health Issues

Open original LDA filing ↗

Cited source text, amounts, lobbyists, and targets

H.R. 3, Lower Drug Costs Now Act of 2019, including provisions relating to international reference pricing H.R. 2069/S. 474, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act H.R. 2296, More Efficient Tools to Realize Information for Consumers Act H.R. 4100/S. 1712, Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act of 2019. including provisions relating to Anti-microbial Resistance H.R. 4455, Bolstering Innovative Options to Save Immediately on Medicines (BIOSIM) Act H.R. 4597, Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019 H.R. 4629, Star Rating for Biosimilars Act H.R. 5076, Protecting Seniors Through Immunization Act of 2019 H.R. 6197, Increasing Access to Biosimilars Act of 2020 H.R. 8061, Community Immunity During COVID-19 Act of 2020 S. 1209, Reforming Evergreening and Manipulation that Extends Drug Years Act S. 1895, Lower Health Care Costs Act S. 2543, Prescription Drug Pricing Reduction Act of 2019 Issues relating to, 340B Reforms; 340B program integrity; 340B of the Public Health Services Act; Drug pricing; Anti-microbial Resistance; General Pharmaceutical issues transparency, formulary design, prescription drug coverage; Biosimiliars; Cost and value of medicines; Maternal Health; Vaccines; Adult vaccines and immunizations; Supply chain; Coronavirus stimulus funding; HIV; Rebate pass through; COVID-19 vaccines; Vaccines catch up; Proposed rule on Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Products (79 Fed. Reg. 75,506-75,527, December 18, 2014); Coronavirus Aid Relief, and Economic Security (CARES) Act (P.L. 116-146)

Client expense: $980,000 · Firm income: Not reported

S. 474

ADAM HUFTALEN BRADLEY ROSSIN COREY MALMGREN ELIZABETH SCHWARTZ ERIN DARLING ROBERT FILIPPONE

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

BRISTOL-MYERS SQUIBB COMPANYclient→BRISTOL-MYERS SQUIBB COMPANY

2020 · third_quarter · Medicare/Medicaid

Open original LDA filing ↗

Cited source text, amounts, lobbyists, and targets

H.R. 107, Burgess: Rebate cap, regarding all bio-pharmaceutical related provisions. H.R. 275, Medicare Prescription Drug Negotiation Act, regarding all bio-pharmaceutical related provisions. H.R. 366, Insulin Access for All Act, regarding all bio-pharmaceutical related provisions. H.R. 1034, D. Collins/S. 640, Kennedy: Phair Pricing Act - Share the savings, regarding all bio-pharmaceutical related provisions. H.R. 1035, Prescription Drug Price Transparency Act, regarding all bio-pharmaceutical related provisions. H.R. 1332, Fair Care Act, regarding all bio-pharmaceutical related provisions. H.R. 1346, Medicare Buy-In and Health Care Stabilization Act, regarding all bio-pharmaceutical related provisions. H.R. 1384, Medicare for All Act, regarding all bio-pharmaceutical related provisions. H.R. 1781, Payment Commission Data Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 1788, Limits the penalty for Part B late enrollment to 15 percent and twice the period of no enrollment, regarding all bio-pharmaceutical related provisions. H.R. 2087, Reporting drug pricing information to Medicare, regarding all bio-pharmaceutical related provisions. H.R. 2113, Prescription STAR Act, regarding all bio-pharmaceutical related provisions. H.R.3, Lower Drug Costs Now Act of 2019, regarding all bio-pharmaceutical related provisions S. 62, Empowering Medicare Seniors to Negotiate Drug Prices, regarding all bio-pharmaceutical related provisions. S. 99, Medicare Drug Price Negotiation Act, regarding all bio-pharmaceutical related provisions. S. 205, Right Rebate Act, regarding all bio-pharmaceutical related provisions. S. 377/H.R. 1046, Medicare Negotiation and Competitive Licensing Act, regarding all bio-pharmaceutical related provisions. S. 470, Medicare at 50 Act, regarding all bio-pharmaceutical related provisions. S. 474, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 , regarding all bio-pharmaceutical related provisions. S. 475, RxCAP Act, regarding all bio-pharmaceutical related provisions. S. 476, Creating Transparency to Have Drug Rebates Unlocked (C-THRU Act) of 2019, regarding all bio-pharmaceutical related provisions. S. 551, REFUND Act of 2019, regarding all bio-pharmaceutical related provisions. S. 691, Expands Part D OOP assistance for low-income seniors and individuals with disabilities, regarding all bio-pharmaceutical related provisions. S. 801/H.R. 1781, Allows MedPAC and MACPAC to have access to information on drug rebates, regarding all bio-pharmaceutical related provisions. S. 981, Medicare-X Choice Act of 2019, regarding all bio-pharmaceutical related provisions. Pending rule to change the Rebate Safe Harbor, regarding all bio-pharmaceutical related provisions. H.R. 1839, Medicaid Services Investment and Accountability Act, regarding all bio-pharmaceutical related provisions H.R. 2452, Medicare for America Act, regarding all bio-pharmaceutical related provisions H.R. 3107, Improving Seniors Timely Access to Care Act, regarding all bio-pharmaceutical related provisions H.R. 3327, Drug Price Transparency for Medicare Patients Act, regarding all bio-pharmaceutical related provisions S. 1261/H.R. 2463, Choose Medicare Act, regarding all bio-pharmaceutical related provisions S. 1497, Health Care Price Check Act, regarding all bio-pharmaceutical related provisions S. 2081, a bill to require drug manufacturers to provide rebates for drugs furnished under Medicare Part B for which the growth in average sales price has exceeded inflation, regarding all bio-pharmaceutical related provisions. S. 2543, Prescription Drug Pricing Reduction Act of 2019, regarding all bio-pharmaceutical provisions. H.R. 19/S.3129 , Lower Costs, More Cures Act of 2019, regarding all bio-pharmaceutical related provisions H.R. 6218/S. 3457, Preserving Patient Access to Home Infusion Act, regarding all bio-pharmaceutical related provisions No Bill, Reimbursement for and patient access to Chimeric Antigen Receptor (CAR) T-cell therapies.

Client expense: $1,600,000 · Firm income: Not reported

S. 474

CHRISTOPHER PERNIE GREG CHESMORE JOHN DEOUDES LANE PENRY THOMAS BRUNET mr PAUL WILLIAMS mr RICARDO SANCHEZ ORTEGON

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, U.S. Trade Representative (USTR)

NATIONAL COMMUNITY PHARMACISTS ASSOCIATIONclient→NATIONAL COMMUNITY PHARMACISTS ASSOCIATION

2020 · third_quarter · Health Issues

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Cited source text, amounts, lobbyists, and targets

S. 474, Stop the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act; H.R. 447 / S. 97, Affordable and Safe Prescription Drug Importation Act; S. 61 / H.R. 478, Safe and Affordable Drugs from Canada Act of 2019; S. 102 / H.R. 465, Prescription Drug Price Relief Act of 2019; H.R.1478, Affordable Insulin Act of 2019; S. 3, Keeping Health Insurance Affordable Act of 2019; H.R 965 / S. 340, CREATES Act of 2019; H.R. 1332, Fair Care Act of 2019; S. 637, CURE High Drug Prices Act; H.R. 1499, Protecting Consumer Access to Generic Drugs Act of 2019; S. 657, A bill to amend title XXVII of the Public Health Service Act to establish requirements with respect to prescription drug benefits; S. 709, Prescription Drug Pricing Dashboard Act; S. 977, Transparent Drug Pricing Act of 2019; S. 1895, Lower Health Care Costs Act; H.R. 2296, FAIR Drug Pricing Act of 2019; H.R. 3947, the Competition Prescription Act of 2019; H.R. 2279, the Safe Step Act; H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act; S. 2543, the Prescription Drug Pricing Reduction Act of 2019; H.R. 19 / S. 3129, the Lower Costs, More Cures Act of 2019; S. 4199, the Prescription Drug Pricing Reduction Act of 2020

Client expense: $330,000 · Firm income: Not reported

S. 474

ANNE CASSITY KARRY LA VIOLETTE PHILLIP HARBISON RONNA HAUSER

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), SENATE, Small Business Administration (SBA), Substance Abuse & Mental Health Services Administration (SAMHSA), White House Office

BIOTECHNOLOGY INNOVATION ORGANIZATIONclient→BIOTECHNOLOGY INNOVATION ORGANIZATION

2020 · second_quarter · Health Issues

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Cited source text, amounts, lobbyists, and targets

21st Century Cures Act 2.0 ---RFI from House Energy and Commerce Committee 340B Drug Discount Program ---340B Pause Act (Discussion Draft House/Senate) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Nonfunding) ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Executive Order on Modernizing Influenza Vaccines ---Gene editing ---Implementation of 21st Century Cures Act of 2016 ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---National Biodefense Strategy ---Tropical Disease Priority Review Voucher (PRV) Program Biosimilars ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---Biosimilar Copay ---Brazil Biologics Regulations ---BSUFA ---Canada Biologics Regulations ---Coding ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 ---Implementation of CREATES Act of 2019 ---India Biologics Regulations ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---Reimbursement Climate Change ---RFI from House Select Committee on the Climate Crisis Coronavirus (COVID-19) Pandemic ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019 ---H.R.6206: Pandemic Response and Emergency Preparedness (PREP) Act of 2020 ---H.R.6260/S.3545: Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavirus Patients Act of 2020 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---COVID-19 Vaccine and Therapeutic Development ---Drug Supply Chain Management ---Healthcare Disparities ---Home Administration of Part B Drugs ---Liability ---Medicare reimbursement policies ---Patient Cost-Sharing and Smoothing ---Pricing-related Provisions ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Senate HELP Pandemic Preparedness White Paper Drug Evaluation and Review ---S.1617: Second Look at Drug Patents Act of 2019 ---S.3872: Promising Pathway Act ---Compassionate Use/Expanded Access ---Expedited Pathways ---Priority Review Voucher Programs Drug Manufacturing, Quality & Distribution ---Drug Shortages ---Drug Supply Chain Management Drug Patenting ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 Drug Pricing ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1093/S.378: Stop Price Gouging Act of 2019 ---H.R.1425: The Patient Protection and Affordable Care Enhancement Act of 2020 ---H.R.2069/S.474: Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 ---H.R.2113: Prescription Drug STAR Act of 2019 ---H.R.2376/S.1227: Prescription Pricing for the People Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---CMMI Authority ---General ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Implementation of CREATES Act of 2019 ---International Pricing Index Proposal ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Potential Administration Executive Orders ---Pricing-related Provisions Foreign Drug Data Protection Laws ---Regulatory Harmonization Funding for Antimicrobial Resistance Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Health Defense Operations Funding Designation ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for FDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 Funding for Health Resources and Services Administration (HRSA) - Vaccine Injury Compensation Program (VICP) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for National Institutes of Health ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Funding for 2020-21 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Medicaid ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Alternative payment arrangements for gene therapies ---Average Manufacturer Price Calculations ---Pricing and Rebates Medicare Expansion ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 Orphan Drug Issues ---H.R.4439/S.4010: Creating Hope Reauthorization Act of 2019 ---H.R.4712: Fairness in Orphan Drug Exclusivity Act of 2019 ---Tax Credit Rare Pediatric Disease Priority Review ---H.R.4439/S.4010: Creating Hope Reauthorization Act of 2019 Reimbursement and Coverage of Innovative Products ---H.R.275: Medicare Prescription Drug Price Negotiation Act of 2019 ---H.R.5122: To prohibit further action on the proposed rule regarding testing of Medicare Part B Prescription Drug Models ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---S.2326: New Opportunities for Value that Extend Lives (NOVEL) Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Administration Rebate Rule ---CMMI Authority ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Home Administration of Part B Drugs ---International Pricing Index Proposal ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Surprise Billing ---Value-based Contracting and Communications The United States-Mexico-Canada Agreement (USMCA) ---Implementation of United States-Mexico-Canada Agreement (USMCA) ---IP Provisions Trade and Foreign Drug Price Controls US-China Trade Agreement ---IP Provisions US-EU Trade Agreement ---IP Provisions US-Japan Trade Agreement ---IP Provisions US-Kenya Trade Agreement ---IP Provisions US-UK Trade Agreement ---IP Provisions Vaccines and Infectious Diseases ---H.R.2862/S.1619: Vaccine Awareness Campaign to Champion Immunization Nationally and Enhance Safety (VACCINES) Act of 2019 ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Adult Immunization Education ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Maternal Immunization ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program

Client expense: $3,320,000 · Firm income: Not reported

S.474

ANDREW CONNER CLAIRE BRANDEWIE DANIEL DURHAM DAVID LACHMANN HAYLEY ALEXANDER JAMIE GREGORIAN JEANNE HAGGERTY JOHN MURPHY JOSEPH DAMOND MICHAEL MATTOON PHYLLIS ARTHUR SHEA HARTLEY mr MATTHEW O'MARA ms AIKEN HACKETT ms ELIZABETH ESHAM

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

NATIONAL COMMUNITY PHARMACISTS ASSOCIATIONclient→NATIONAL COMMUNITY PHARMACISTS ASSOCIATION

2020 · second_quarter · Health Issues

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Cited source text, amounts, lobbyists, and targets

S. 474, Stop the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act; H.R. 447 / S. 97, Affordable and Safe Prescription Drug Importation Act; S. 61 / H.R. 478, Safe and Affordable Drugs from Canada Act of 2019; S. 102 / H.R. 465, Prescription Drug Price Relief Act of 2019; H.R.1478, Affordable Insulin Act of 2019; S. 3, Keeping Health Insurance Affordable Act of 2019; H.R 965 / S. 340, CREATES Act of 2019; H.R. 1332, Fair Care Act of 2019; S. 637, CURE High Drug Prices Act; H.R. 1499, Protecting Consumer Access to Generic Drugs Act of 2019; S. 657, A bill to amend title XXVII of the Public Health Service Act to establish requirements with respect to prescription drug benefits; S. 709, Prescription Drug Pricing Dashboard Act; S. 977, Transparent Drug Pricing Act of 2019; S. 1895, Lower Health Care Costs Act; H.R. 2296, FAIR Drug Pricing Act of 2019; H.R. 3947, the Competition Prescription Act of 2019; H.R. 2279, the Safe Step Act; H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act; S. 2543, the Prescription Drug Pricing Reduction Act of 2019; H.R. 19 / S. 3129, the Lower Costs, More Cures Act of 2019

Client expense: $360,000 · Firm income: Not reported

S. 474

ANNE CASSITY KARRY LA VIOLETTE PHILLIP HARBISON REEMA TANEJA RONNA HAUSER

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), SENATE, Small Business Administration (SBA), Substance Abuse & Mental Health Services Administration (SAMHSA), White House Office

BRISTOL-MYERS SQUIBB COMPANYclient→BRISTOL-MYERS SQUIBB COMPANY

2020 · second_quarter · Medicare/Medicaid

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Cited source text, amounts, lobbyists, and targets

H.R. 107, Burgess: Rebate cap, regarding all bio-pharmaceutical related provisions. H.R. 275, Medicare Prescription Drug Negotiation Act, regarding all bio-pharmaceutical related provisions. H.R. 366, Insulin Access for All Act, regarding all bio-pharmaceutical related provisions. H.R. 1034, D. Collins/S. 640, Kennedy: Phair Pricing Act - Share the savings, regarding all bio-pharmaceutical related provisions. H.R. 1035, Prescription Drug Price Transparency Act, regarding all bio-pharmaceutical related provisions. H.R. 1332, Fair Care Act, regarding all bio-pharmaceutical related provisions. H.R. 1346, Medicare Buy-In and Health Care Stabilization Act, regarding all bio-pharmaceutical related provisions. H.R. 1384, Medicare for All Act, regarding all bio-pharmaceutical related provisions. H.R. 1781, Payment Commission Data Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 1788, Limits the penalty for Part B late enrollment to 15 percent and twice the period of no enrollment, regarding all bio-pharmaceutical related provisions. H.R. 2087, Reporting drug pricing information to Medicare, regarding all bio-pharmaceutical related provisions. H.R. 2113, Prescription STAR Act, regarding all bio-pharmaceutical related provisions. H.R.3, Lower Drug Costs Now Act of 2019, regarding all bio-pharmaceutical related provisions S. 62, Empowering Medicare Seniors to Negotiate Drug Prices, regarding all bio-pharmaceutical related provisions. S. 99, Medicare Drug Price Negotiation Act, regarding all bio-pharmaceutical related provisions. S. 205, Right Rebate Act, regarding all bio-pharmaceutical related provisions. S. 377/H.R. 1046, Medicare Negotiation and Competitive Licensing Act, regarding all bio-pharmaceutical related provisions. S. 470, Medicare at 50 Act, regarding all bio-pharmaceutical related provisions. S. 474, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 , regarding all bio-pharmaceutical related provisions. S. 475, RxCAP Act, regarding all bio-pharmaceutical related provisions. S. 476, Creating Transparency to Have Drug Rebates Unlocked (C-THRU Act) of 2019, regarding all bio-pharmaceutical related provisions. S. 551, REFUND Act of 2019, regarding all bio-pharmaceutical related provisions. S. 691, Expands Part D OOP assistance for low-income seniors and individuals with disabilities, regarding all bio-pharmaceutical related provisions. S. 801/H.R. 1781, Allows MedPAC and MACPAC to have access to information on drug rebates, regarding all bio-pharmaceutical related provisions. S. 981, Medicare-X Choice Act of 2019, regarding all bio-pharmaceutical related provisions. Pending rule to change the Rebate Safe Harbor, regarding all bio-pharmaceutical related provisions. H.R. 1839, Medicaid Services Investment and Accountability Act, regarding all bio-pharmaceutical related provisions H.R. 2452, Medicare for America Act, regarding all bio-pharmaceutical related provisions H.R. 3107, Improving Seniors Timely Access to Care Act, regarding all bio-pharmaceutical related provisions H.R. 3327, Drug Price Transparency for Medicare Patients Act, regarding all bio-pharmaceutical related provisions S. 1261/H.R. 2463, Choose Medicare Act, regarding all bio-pharmaceutical related provisions S. 1497, Health Care Price Check Act, regarding all bio-pharmaceutical related provisions S. 2081, a bill to require drug manufacturers to provide rebates for drugs furnished under Medicare Part B for which the growth in average sales price has exceeded inflation, regarding all bio-pharmaceutical related provisions. S. 2543, Prescription Drug Pricing Reduction Act of 2019, regarding all bio-pharmaceutical provisions. H.R. 19/S.3129 , Lower Costs, More Cures Act of 2019, regarding all bio-pharmaceutical related provisions H.R. 6218/S. 3457, Preserving Patient Access to Home Infusion Act, regarding all bio-pharmaceutical related provisions No Bill, Reimbursement for and patient access to Chimeric Antigen Receptor (CAR) T-cell therapies.

Client expense: $2,160,000 · Firm income: Not reported

S. 474

CHRISTOPHER PERNIE GREG CHESMORE JOHN DEOUDES LANE PENRY STEVE RUBRIGHT THOMAS BRUNET mr PAUL WILLIAMS mr RICARDO SANCHEZ ORTEGON

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, U.S. Trade Representative (USTR)

GSK (FKA GLAXOSMITHKLINE INC.)client→GSK (FKA GLAXOSMITHKLINE INC.)

2020 · first_quarter · Health Issues

Open original LDA filing ↗

Cited source text, amounts, lobbyists, and targets

H.R. 965: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 985: FAST Generics Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 1093: Stop Price Gouging Act - Provisions related to prescription drug pricing H.R. 1323: Rural Hospital Frontier Fairness Act - Provisions related to the 340B drug discount program H.R. 2296: FAIR Drug Pricing Act of 2019 / More Efficient Tools to Realize Information for Consumers Act - Provisions related to prescription drug pricing and transparency H.R. 2376: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers H.R. 4812: Ensuring Compliance Against Drug Diversion Act of 2019 - Provisions related to registrations under the Controlled Substances Act H.R. 5239: Prescription Drug Price Reporting Act - Provisions related to prescription drug pricing transparency H.R. 5668: MODERN Labeling Act of 2020 - Provisions related to prescription drug labeling H.R. 6019: Cure the Coronavirus Act - Provisions related to FDA prescription drug approvals H.R. 6080: Preventing Drug Shortages Act - Provisions related to prescription drug shortage reporting requirements H.R. 6173: Covering Coronavirus Test Act of 2020 - Provisions related to medical device pricing and coverage H.R. 6213: No Cost for COVID-19 Testing Act - Provisions related to medical device pricing and coverage H.R. 6222: Ensuring Affordable COVID-19 Preventive Care Act of 2020 - Provisions related to prescription drug pricing and access H.R. 6231: Ensuring Access to COVID-19 Preventive Care Act of 2020 - Provisions related to prescription drug pricing and access H.R. 6253: To expand certain securities exemptions to respond to COVID-19, to establish an X-prize for creating an effective COVID-19 vaccine, and for other purposes - Provisions related to prescription drug research and development H.R. 6261: To provide for coverage of testing for COVID-19 at no cost sharing for Indians receiving health services through the Indian Health Service, and for other purposes - Provisions related to medical device pricing and coverage H.R. 6264: To prohibit price gouging during a state of emergency declaration, and for other purposes - Provisions related to prescription drug and medical device pricing H.R. 6351: To authorize the Secretary of Health and Human Services to administer vaccinations for COVID-19, once available, at no cost to the inoculated, in response to the COVID-19 outbreak, and for other purposes - Provisions related to prescription drug patient access and cost sharing H.R. 6390: To require the President to use authorities under the Defense Production Act of 1950 to require emergency production of medical equipment to address the COVID-19 outbreak - Provisions related to the Defense Production Act H.R. 6410: To direct the President to use authority under the Defense Production Act of 1950 to ensure an adequate supply equipment necessary for limiting the spread of COVID-19 - Provisions related to the Defense Production Act S. 61: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation S. 73: End Taxpayer Subsidies for Drug Ads Act - Provisions related to direct-to-consumer prescription drug advertising S. 340: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 474: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2019 - Provisions related to increases in the wholesale acquisition costs of prescription drugs S. 637: Combatting Unreasonable Rises and Excessively (CURE) High Drug Prices Act - Provisions related to prescription drug pricing and transparency S. 657: Drug Price Transparency Act - Provisions related to prescription drug pricing transparency and commercial market rebates S. 660: Efficiency and Transparency in Petitions Act - Provisions related to the FDA citizen petition process S. 801: Payment Commission Data Act of 2019 - Provisions related to prescription drug pricing transparency S. 977: Transparent Drug Pricing Act of 2019 - Provisions related to prescription drug pricing and foreign reference pricing S. 1089: Restoring Access to Medication Act of 2019 - Provisions related to prescription drug access S. 1227: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 1384: Prescription Drug Rebate Reform Act of 2019 - Provisions related to prescription drug pricing and negotiated rebates S. 1391: FAIR Drug Pricing Act of 2019 - Provisions related to prescription drug pricing and transparency S. 1437: Drug-price Transparency in Communications (DTC) Act - Provisions related to direct-to-consumer prescription drug advertising S. 1532: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 1567: Finding Orphan-disease Remedies With Antifungal Research and Development Act of 2019 - Provisions related to rare disease research and funding S1872/HR5076 Protecting Seniors Through Immunization Act S. 1897: A bill to establish a process for updating the labeling of certain drugs with outdated labeling - Provisions related to prescription drug labeling S. 2004: Emergency Access to Insulin Act of 2019 - Provisions related to prescription drug pricing S. 2103: Affordable Insulin Approvals Now Act - Provisions related to FDA prescription drug approvals S. 2161: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 - Provisions related to reciprocity S. 2304: Strategies To Address Antibiotic Resistance Act - Provisions related to antimicrobial resistance (AMR) and other issues S. 2723: Mitigating Emergency Drug Shortages Act - Provisions related to prescription drug pricing transparency and other provisions S. 2897: Patient-Centered Outcomes Research Institute Reauthorization Act - Provisions related to PCORI reauthorization S. 3162: Affordable Drug Manufacturing Act of 2019 - Provisions related to prescription drug manufacturing S. 3166: Prescription Drug Affordability and Access Act - Provisions related to prescription drug pricing S. 3180: Responsibility in Drug Advertising Act of 2020 - Provisions related to prescription drug direct-to-consumer advertising S. 3384: Lowering Prescription Drug Prices for America's Seniors and Families Act of 2020 - Provisions related to prescription drug price negotiation, importation, and other issues S. 3439: Lower Health Insurance Deductibles Act - Provisions related to prescription drug pricing and insurance plan design S. 3432: Securing America's Medicine Cabinet Act of 2020 - Provisions related to advanced manufacturing and prescription drugs S. 3442: Care for COVID-19 Act - Provisions related to prescription drug pricing and access S. 3499: A bill to amend coverage requirements to ensure that no person incurs cost sharing when receiving a test to confirm a COVID-19 infection - Provisions related to medical device pricing and access S. 3505: A bill to require private health insurance to rapidly cover preventive services and vaccines related to the coronavirus - Provisions related to prescription drug pricing and access S. 3545: A bill to amend the Federal Food, Drug, and Cosmetic Act to provide for reciprocal marketing approval of certain drugs, biological products, and devices that are authorized to be lawfully marketed abroad, and for other purposes - Provisions related to FDA prescription drug marketing approvals S. 3564: A bill to amend title XIX of the Social Security Act to require States to provide medical assistance for COVID-19 treatment services for individuals who are diagnosed with COVID-19, and for other purposes - Provisions related to prescription drug pricing and access S. 3570: A bill to provide for the expedited procurement of equipment needed to combat COVID-19 under the Defense Production Act of 1950 - Provisions related to the Defense Production Act Transparency policy issues Drug cost and pricing policy issues Drug importation and counterfeiting policy issues HHS Safe Importation Action Plan Prescription drug take back and secure disposal policy issues Expanded access policy issues Antimicrobial resistance policy issues High deductible health plans/HSA policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues FDA modernization policy issues PDUFA implementation policy issues Monograph Reform CDC Programmatic Funding Restoration of HSA/FSAs 340B drug discount program policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions Patient assistance program policy issues Foreign manufacturing policy issues Biosimilar approval and reimbursement policy issues Cancer drug vial size policy issues Drug shortages policy issues Proposed Rule; Importation of Prescription Drugs (RIN 0910-AI45) Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients

Client expense: $940,000 · Firm income: Not reported

S. 474

JENNIFER DALE MICHAEL CALVO PHILIP THEVENET mr ALEC HINOJOSA mr WILLIAM SCHUYLER ms KIMBERLY WILLIAMS

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)

NOVARTISclient→NOVARTIS

2020 · first_quarter · Health Issues

Open original LDA filing ↗

Cited source text, amounts, lobbyists, and targets

S.2543 - Prescription Drug Pricing Reduction Act of 2019 HR 1520: Purple Book Continuity Act HR 1503: Orange Book Transparency Act HR 1499: Protecting Consumer Access to Generic Drugs Act Fast Generics Cell & Gene Therapy, including reimbursement 340B Drug Discount Program Drug Importation Drug Cost/Pricing Biosimilars Reimbursement Outcomes based Contracting Part D Non-interference Orphan Drugs Virtual Clinical Trials Part D Benefit Redesign Biosimilar Pass Through Payments Value Based Pricing Medicaid Payment Reform AMP Cap Labor HHS Appropriations S 1895 - Lower Health Care Costs Act HR 987 - Strengthening Health Care and Lowering Prescription Drug Costs Act H.R.478 - Safe and Affordable Drugs from Canada Act of 2019 H.R.985 - FAST Generics Act of 2019 H.R.2011 - Protecting Access to Biosimilars Act of 2019 H.R.2296 - FAIR Drug Pricing Act of 2019 S.61 - Safe and Affordable Drugs from Canada Act of 2019 S.474 - Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 S.1140 - Protecting Access to Biosimilars Act of 2019 S.1384 - Prescription Drug Rebate Reform Act of 2019 S.1391 - Fair Accountability and Innovative Research Drug Pricing Act of 2019 S.1227 - Prescription Pricing for the People Act of 2019 H.R.447 - Affordable and Safe Prescription Drug Importation Act H.R.1922 - Restoring Access to Medication Act of 2019 H.R.2064 - To amend title XI of the Social Security Act to require manufacturers of certain drugs, devices, biologicals, and medical supplies to report on product samples provided to certain health care providers, and for other purposes H.R.5304 - PBM Transparency in Prescription Drug Costs Act S.97 - Affordable and Safe Prescription Drug Importation Act S.657 - A bill to amend title XXVII of the Public Health Service Act to establish requirements with respect to prescription drug benefits Transparency policy issues Drug cost and pricing policy issues Drug importation and counterfeiting policy issues HHS Safe Importation Action Plan Expanded access policy issues Generic drug approval process policy issues PDUFA implementation policy issues 340B drug discount program policy issues Cancer drug vial size policy issues Pharmaceutical supply chain Pharmaceutical quality H.R 6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 H.R. 6201 - Families First Coronavirus Response Act (COVID 2) H.R. 748 and S. 3548 - Coronavirus Aid, Relief, and Economic Security Act (CARES Act) H.R. 2740: Labor, Health and Human Services, Education, Defense, State, Foreign Operations, and Energy and Water Development Appropriations Act, 2020 - HHS provisions related to prescription drugs Making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for the fiscal year ending September 30, 2020, and for other purposes H.R. 3772, Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019 H.R. 748: CARES Act - Provisions related to Part B, Part D, vaccines, transparency, and transportation H.R. 6074: Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 - Provisions related to biomedical research and prescription drug pricing S. 3370: Coronavirus Vaccine Act - Provisions related to NIH funding S. 3548: CARES Act - Provisions related to supplemental appropriations and federal health programs H.R. 6080: Preventing Drug Shortages Act - Provisions related to prescription drug shortage reporting requirements Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Drug shortages policy issues Proposed Rule; Importation of Prescription Drugs (RIN 0910-AI45) FDA modernization policy issues PDUFA implementation policy issues 340B drug discount program policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions Patient assistance program policy issues Foreign manufacturing policy issues

Client expense: $3,350,000 · Firm income: Not reported

S.474

COURTNEY LEE-ASHLEY DANIEL CASSERLY JOSEPH MCGOWAN LEO FARBER NORA CONNORS SARAH HALLER SEEMIN PASHA SHELLY MUI-LIPNIK TAYLOR BOOTH

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office

PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICAclient→PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA

2020 · first_quarter · Health Issues

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Cited source text, amounts, lobbyists, and targets

H.R. 965: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 985: FAST Generics Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 1093: Stop Price Gouging Act - Provisions related to prescription drug pricing H.R. 1323: Rural Hospital Frontier Fairness Act - Provisions related to the 340B drug discount program H.R. 2296: FAIR Drug Pricing Act of 2019 / More Efficient Tools to Realize Information for Consumers Act - Provisions related to prescription drug pricing and transparency H.R. 2376: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers H.R. 4812: Ensuring Compliance Against Drug Diversion Act of 2019 - Provisions related to registrations under the Controlled Substances Act H.R. 5239: Prescription Drug Price Reporting Act - Provisions related to prescription drug pricing transparency H.R. 5382: To create a mechanism whereby insulin manufacturers may sell directly to consumers at current net prices. - Provisions related to prescription drug pricing H.R. 5668: MODERN Labeling Act of 2020 - Provisions related to prescription drug labeling H.R. 6019: Cure the Coronavirus Act - Provisions related to FDA prescription drug approvals H.R. 6080: Preventing Drug Shortages Act - Provisions related to prescription drug shortage reporting requirements H.R. 6173: Covering Coronavirus Test Act of 2020 - Provisions related to medical device pricing and coverage H.R. 6213: No Cost for COVID-19 Testing Act - Provisions related to medical device pricing and coverage H.R. 6222: Ensuring Affordable COVID-19 Preventive Care Act of 2020 - Provisions related to prescription drug pricing and access H.R. 6231: Ensuring Access to COVID-19 Preventive Care Act of 2020 - Provisions related to prescription drug pricing and access H.R. 6253: To expand certain securities exemptions to respond to COVID-19, to establish an X-prize for creating an effective COVID-19 vaccine, and for other purposes - Provisions related to prescription drug research and development H.R. 6261: To provide for coverage of testing for COVID-19 at no cost sharing for Indians receiving health services through the Indian Health Service, and for other purposes - Provisions related to medical device pricing and coverage H.R. 6264: To prohibit price gouging during a state of emergency declaration, and for other purposes - Provisions related to prescription drug and medical device pricing H.R. 6351: To authorize the Secretary of Health and Human Services to administer vaccinations for COVID-19, once available, at no cost to the inoculated, in response to the COVID-19 outbreak, and for other purposes - Provisions related to prescription drug patient access and cost sharing H.R. 6390: To require the President to use authorities under the Defense Production Act of 1950 to require emergency production of medical equipment to address the COVID-19 outbreak - Provisions related to the Defense Production Act H.R. 6410: To direct the President to use authority under the Defense Production Act of 1950 to ensure an adequate supply equipment necessary for limiting the spread of COVID-19 - Provisions related to the Defense Production Act S. 61: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation S. 73: End Taxpayer Subsidies for Drug Ads Act - Provisions related to direct-to-consumer prescription drug advertising S. 340: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 474: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2019 - Provisions related to increases in the wholesale acquisition costs of prescription drugs S. 637: Combatting Unreasonable Rises and Excessively (CURE) High Drug Prices Act - Provisions related to prescription drug pricing and transparency S. 657: Drug Price Transparency Act - Provisions related to prescription drug pricing transparency and commercial market rebates S. 660: Efficiency and Transparency in Petitions Act - Provisions related to the FDA citizen petition process S. 801: Payment Commission Data Act of 2019 - Provisions related to prescription drug pricing transparency S. 977: Transparent Drug Pricing Act of 2019 - Provisions related to prescription drug pricing and foreign reference pricing S. 1089: Restoring Access to Medication Act of 2019 - Provisions related to prescription drug access S. 1227: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 1384: Prescription Drug Rebate Reform Act of 2019 - Provisions related to prescription drug pricing and negotiated rebates S. 1391: FAIR Drug Pricing Act of 2019 - Provisions related to prescription drug pricing and transparency S. 1437: Drug-price Transparency in Communications (DTC) Act - Provisions related to direct-to-consumer prescription drug advertising S. 1532: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 1567: Finding Orphan-disease Remedies With Antifungal Research and Development Act of 2019 - Provisions related to rare disease research and funding S. 1897: A bill to establish a process for updating the labeling of certain drugs with outdated labeling - Provisions related to prescription drug labeling S. 2004: Emergency Access to Insulin Act of 2019 - Provisions related to prescription drug pricing S. 2103: Affordable Insulin Approvals Now Act - Provisions related to FDA prescription drug approvals S. 2161: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 - Provisions related to reciprocity S. 2304: Strategies To Address Antibiotic Resistance Act - Provisions related to antimicrobial resistance (AMR) and other issues S. 2723: Mitigating Emergency Drug Shortages Act - Provisions related to prescription drug pricing transparency and other provisions S. 2897: Patient-Centered Outcomes Research Institute Reauthorization Act - Provisions related to PCORI reauthorization S. 3162: Affordable Drug Manufacturing Act of 2019 - Provisions related to prescription drug manufacturing S. 3166: Prescription Drug Affordability and Access Act - Provisions related to prescription drug pricing S. 3180: Responsibility in Drug Advertising Act of 2020 - Provisions related to prescription drug direct-to-consumer advertising S. 3384: Lowering Prescription Drug Prices for America's Seniors and Families Act of 2020 - Provisions related to prescription drug price negotiation, importation, and other issues S. 3439: Lower Health Insurance Deductibles Act - Provisions related to prescription drug pricing and insurance plan design S. 3432: Securing America's Medicine Cabinet Act of 2020 - Provisions related to advanced manufacturing and prescription drugs S. 3442: Care for COVID-19 Act - Provisions related to prescription drug pricing and access S. 3468 Preventing Essential Medical Device Shortages Act of 2020 - Provisions related to medical device shortage reporting requirements S. 3499: A bill to amend coverage requirements to ensure that no person incurs cost sharing when receiving a test to confirm a COVID-19 infection - Provisions related to medical device pricing and access S. 3505: A bill to require private health insurance to rapidly cover preventive services and vaccines related to the coronavirus - Provisions related to prescription drug pricing and access S. 3545: A bill to amend the Federal Food, Drug, and Cosmetic Act to provide for reciprocal marketing approval of certain drugs, biological products, and devices that are authorized to be lawfully marketed abroad, and for other purposes - Provisions related to FDA prescription drug marketing approvals S. 3564: A bill to amend title XIX of the Social Security Act to require States to provide medical assistance for COVID-19 treatment services for individuals who are diagnosed with COVID-19, and for other purposes - Provisions related to prescription drug pricing and access S. 3568: To require the President to use authorities under the Defense Production Act of 1950 to require emergency production of medical equipment to address the COVID-19 outbreak - Provisions related to the Defense Production Act S. 3570: A bill to provide for the expedited procurement of equipment needed to combat COVID-19 under the Defense Production Act of 1950 - Provisions related to the Defense Production Act Transparency policy issues Drug cost and pricing policy issues Drug importation and counterfeiting policy issues HHS Safe Importation Action Plan Prescription drug take back and secure disposal policy issues Policy issues related to prescription drug abuse and opioids Expanded access policy issues Antimicrobial resistance policy issues High deductible health plans/HSA policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues FDA modernization policy issues PDUFA implementation policy issues 340B drug discount program policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions Patient assistance program policy issues Foreign manufacturing policy issues Biosimilar approval and reimbursement policy issues Cancer drug vial size policy issues Drug shortages policy issues Proposed Rule; Importation of Prescription Drugs (RIN 0910-AI45) Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients

Client expense: $9,020,000 · Firm income: Not reported

S. 474

ANNE ESPOSITO ANNE PRITCHETT BART FORSYTH BRIDGETT TAYLOR COLLEEN MALONEY DAVID KORN ERIN HERMANCE ERIN MENDELSOHN JAMES STANSEL KELLY GOLDBERG LISA JOLDERSMA LORI REILLY MATTHEW STURM NATALIE BURKHALTER NICK SHIPLEY NICOLAS MAGALLANES RANDY BURKHOLDER RYAN KAAT SHANNON STEHOUWER ms JENNIFER BRYANT

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)client→HORIZON THERAPEUTICS USA, INC. (FKA HORIZON PHARMA USA, INC.)

2020 · first_quarter · Health Issues

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Cited source text, amounts, lobbyists, and targets

CMS Rule CMS-1711-P relating to Medicare and Medicaid Programs, "CY 2020 Home Health Prospective Payment System Rate Update, Home Health Value-Based Purchasing Model, Home Health Quality Reporting Requirements, and Home Infusion Therapy Requirements," all provisions. H Res 242 "Affirming the importance of the Orphan Drug Act," all provisions. HR 748 / S 3548 "CARES Act," all provisions pertaining to corporate tax, and CMS home infusion benefits. HR 19 "Lower Costs, More Cures Act of 2019," all provisions. HR 2113 Prescription Drug STAR Act, all provisions. HR 2296 More Efficient Tools to Realize Information for Consumers Act, all provisions. HR 3 "Elijah E. Cummings Lower Drug Costs Now Act," all provisions. Issues related to the implementation of PL 111-148 "Patient Protection and Affordable Care Act," all provisions pertaining to the Center for Medicare and Medicaid Innovation (CMMI) and federal programs. Issues related to the implementation of PL 97-414 "Orphan Drug Act," all provisions. Importation of Prescription Drugs Proposed Rule, Food and Drug Administration (FDA), [Docket No. FDA-2019-N-5711]. Issues relating to improved oversight regulatory requirements for 340B hospital reporting, excluding Federal Grantees. S 1391 "Fair Accountability and Innovative Research Drug Pricing Act of 2019, all provisions. S 474 Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019, all provisions. Issues relating to creating a cystinosis disease awareness day on May 7th. S 2543 Prescription Drug Pricing Reduction Act of 2019, all provisions in Amendment #4 Improving Metrics for Price Reporting for Orphan Drugs Act. CMS Rule CMS-5528-ANPRM relating to Medicare Program, "International Pricing Index Model for Medicare Part B Drugs," all provisions. S 1895 Lower Health Care Costs Act, all provisions.

Client expense: $1,280,000 · Firm income: Not reported

S 474

BETH RADA BRENTON FISK ELI KOGAN JORDAN CHAPMAN PARUL PATEL

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Treasury, Dept of

BRISTOL-MYERS SQUIBB COMPANYclient→BRISTOL-MYERS SQUIBB COMPANY

2020 · first_quarter · Medicare/Medicaid

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Cited source text, amounts, lobbyists, and targets

H.R. 107, Burgess: Rebate cap, regarding all bio-pharmaceutical related provisions. H.R. 275, Medicare Prescription Drug Negotiation Act, regarding all bio-pharmaceutical related provisions. H.R. 366, Insulin Access for All Act, regarding all bio-pharmaceutical related provisions. H.R. 1034, D. Collins/S. 640, Kennedy: Phair Pricing Act - Share the savings, regarding all bio-pharmaceutical related provisions. H.R. 1035, Prescription Drug Price Transparency Act, regarding all bio-pharmaceutical related provisions. H.R. 1332, Fair Care Act, regarding all bio-pharmaceutical related provisions. H.R. 1346, Medicare Buy-In and Health Care Stabilization Act, regarding all bio-pharmaceutical related provisions. H.R. 1384, Medicare for All Act, regarding all bio-pharmaceutical related provisions. H.R. 1781, Payment Commission Data Act of 2019, regarding all bio-pharmaceutical related provisions. H.R. 1788, Limits the penalty for Part B late enrollment to 15 percent and twice the period of no enrollment, regarding all bio-pharmaceutical related provisions. H.R. 2087, Reporting drug pricing information to Medicare, regarding all bio-pharmaceutical related provisions. H.R. 2113, Prescription STAR Act, regarding all bio-pharmaceutical related provisions. H.R.3, Lower Drug Costs Now Act of 2019, regarding all bio-pharmaceutical related provisions S. 62, Empowering Medicare Seniors to Negotiate Drug Prices, regarding all bio-pharmaceutical related provisions. S. 99, Medicare Drug Price Negotiation Act, regarding all bio-pharmaceutical related provisions. S. 205, Right Rebate Act, regarding all bio-pharmaceutical related provisions. S. 377/H.R. 1046, Medicare Negotiation and Competitive Licensing Act, regarding all bio-pharmaceutical related provisions. S. 470, Medicare at 50 Act, regarding all bio-pharmaceutical related provisions. S. 474, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 , regarding all bio-pharmaceutical related provisions. S. 475, RxCAP Act, regarding all bio-pharmaceutical related provisions. S. 476, Creating Transparency to Have Drug Rebates Unlocked (C-THRU Act) of 2019, regarding all bio-pharmaceutical related provisions. S. 551, REFUND Act of 2019, regarding all bio-pharmaceutical related provisions. S. 691, Expands Part D OOP assistance for low-income seniors and individuals with disabilities, regarding all bio-pharmaceutical related provisions. S. 801/H.R. 1781, Allows MedPAC and MACPAC to have access to information on drug rebates, regarding all bio-pharmaceutical related provisions. S. 981, Medicare-X Choice Act of 2019, regarding all bio-pharmaceutical related provisions. Pending rule to change the Rebate Safe Harbor, regarding all bio-pharmaceutical related provisions. H.R. 1839, Medicaid Services Investment and Accountability Act, regarding all bio-pharmaceutical related provisions H.R. 2452, Medicare for America Act, regarding all bio-pharmaceutical related provisions H.R. 3107, Improving Seniors Timely Access to Care Act, regarding all bio-pharmaceutical related provisions H.R. 3327, Drug Price Transparency for Medicare Patients Act, regarding all bio-pharmaceutical related provisions S. 1261/H.R. 2463, Choose Medicare Act, regarding all bio-pharmaceutical related provisions S. 1497, Health Care Price Check Act, regarding all bio-pharmaceutical related provisions S. 2081, a bill to require drug manufacturers to provide rebates for drugs furnished under Medicare Part B for which the growth in average sales price has exceeded inflation, regarding all bio-pharmaceutical related provisions. S. 2543, Prescription Drug Pricing Reduction Act of 2019, regarding all bio-pharmaceutical provisions. H.R. 19/S.3129 , Lower Costs, More Cures Act of 2019, regarding all bio-pharmaceutical related provisions H.R. 6218/S. 3457, Preserving Patient Access to Home Infusion Act, regarding all bio-pharmaceutical related provisions No Bill, Reimbursement for and patient access to Chimeric Antigen Receptor (CAR) T-cell therapies.

Client expense: $540,000 · Firm income: Not reported

S. 474

ALANNA TEMME CHRISTOPHER PERNIE GREG CHESMORE LANE PENRY STEVE RUBRIGHT mr PAUL WILLIAMS

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, U.S. Trade Representative (USTR)

NATIONAL COMMUNITY PHARMACISTS ASSOCIATIONclient→NATIONAL COMMUNITY PHARMACISTS ASSOCIATION

2020 · first_quarter · Health Issues

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Cited source text, amounts, lobbyists, and targets

S. 474, Stop the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act; H.R. 447 / S. 97, Affordable and Safe Prescription Drug Importation Act; S. 61 / H.R. 478, Safe and Affordable Drugs from Canada Act of 2019; S. 102 / H.R. 465, Prescription Drug Price Relief Act of 2019; H.R.1478, Affordable Insulin Act of 2019; S. 3, Keeping Health Insurance Affordable Act of 2019; H.R 965 / S. 340, CREATES Act of 2019; H.R. 1332, Fair Care Act of 2019; S. 637, CURE High Drug Prices Act; H.R. 1499, Protecting Consumer Access to Generic Drugs Act of 2019; S. 657, A bill to amend title XXVII of the Public Health Service Act to establish requirements with respect to prescription drug benefits; S. 709, Prescription Drug Pricing Dashboard Act; S. 977, Transparent Drug Pricing Act of 2019; S. 1895, Lower Health Care Costs Act; H.R. 2296, FAIR Drug Pricing Act of 2019; H.R. 3947, the Competition Prescription Act of 2019; H.R. 2279, the Safe Step Act; H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act; S. 2543, the Prescription Drug Pricing Reduction Act of 2019; H.R. 19 / S. 3129, the Lower Costs, More Cures Act of 2019

Client expense: $440,000 · Firm income: Not reported

S. 474

ANNE CASSITY KARRY LA VIOLETTE PHILLIP HARBISON REEMA TANEJA RONNA HAUSER

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), SENATE, Small Business Administration (SBA), Substance Abuse & Mental Health Services Administration (SAMHSA), White House Office

AARPclient→AARP

2020 · first_quarter · Pharmacy

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Cited source text, amounts, lobbyists, and targets

H.R. 6074, Coronavirus Preparedness and Response Supplemental Appropriations Act. H.R. 6201, Families First Coronavirus Response Act; H.R. 748, Coronavirus Aid, Relief, and Economic Security (CARES) Act - Discussed Medicare enrollment national open enrollment period, medical expense deduction, cost-sharing protections for commercial/private health insurance holders, telehealth access, nursing homes, virtual visitation, home and community-based services, Older Americans Act programs, Medicare home health care, and family caregiving, no-cost COVID-19 testing, equitable relief payments, retirement savings tax relief, suspensions of foreclosures and evictions, expanded unemployment benefits, paid sick and family leave, affordable broadband, and government operations, among other issues. H.R. 3, Elijah E. Cummings Lower Cost Drugs Now Act. S. 2543, the Prescription Drug Pricing Reduction Act. S.64/H.R. 2375 - the Preserve Access to Generics and Biosimilars Act. H.R. 1499 - the Preserving Consumer Access to Generics Act. H.R. 2113 - the Prescription STAR Act. H.R. 2296/S.1391 - The FAIR Drug Pricing Act. S.1416 - the Affordable Prescriptions for Patients Act. S.1437, the Drug-price Transparency in Communications (DTC) Act. S.551, the REFUND Act. S.1209, the REMEDY Act. S. 474/H.R. 2069, the SPIKE Act. H.R. 19/S. 3129, Lower Cost More Cures Act.

Client expense: $2,210,000 · Firm income: Not reported

S. 474

AMY KELBICK BEVERLY GILYARD BLAKE KELLY DAVID CERTNER DENISE DEMICHELE-BAILIN FERNANDO RUIZ JOHN HISHTA LEIGH PURVIS MEGAN O'REILLY NANCY LEAMOND NICOLE BURDA RHONDA RICHARDS TIMOTHY GEARAN WILLIAM SWEENEY mr JOHN CUMMINGS jr ms SHANNON RUSSELL

Government targets: Administration for Children & Families (ACF), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Consumer Financial Protection Bureau (CFPB), Corporation for Natl & Community Service, Federal Deposit Insurance Corporation (FDIC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Housing & Urban Development, Dept of (HUD), Indian Health Service, Internal Revenue Service (IRS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Personnel Management (OPM), Office of the Comptroller of the Currency (OCC), Pension Benefit Guaranty Corporation (PBGC), SENATE, Securities & Exchange Commission (SEC), Social Security Administration (SSA), Transportation, Dept of (DOT), Treasury, Dept of, Veterans Affairs, Dept of (VA), White House Office

BIOTECHNOLOGY INNOVATION ORGANIZATIONclient→BIOTECHNOLOGY INNOVATION ORGANIZATION

2019 · fourth_quarter · Health Issues

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Cited source text, amounts, lobbyists, and targets

340B Drug Discount Program ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Antibiotic & Diagnostic Tax Credit Biodefense Research, Development and Procurement Issues (Non-funding) ---Executive Order on Modernizing Influenza Vaccines ---Gene Editing ---H.R.269/S.1379: Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 ---Implementation of Medical Countermeasures Innovation Act ---Implementation of the 21st Century Cures Act of 2016 ---Implementation of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act (PAHPAI) of 2019 ---National Biodefense Strategy ---Pandemic Influenza Preparedness ---Tropical Disease Priority Review Voucher (PRV) Program Biosimilars ---Access to Samples for Testing ---Biosimilar Copay Elimination ---Brazil Biologics Regulations ---Canada Biologics Regulations ---Coding ---H.R.965/S.340: CREATES Act of 2019 ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.1520: Purple Book Continuity Act of 2019 ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 ---India Biologics Regulations ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---Reimbursement ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 ---S.659: Biologic Patent Transparency Act of 2019 Climate Change ---RFI from House Select Committee on the Climate Crisis Comparative Effectiveness Research Initiatives ---Reauthorization of Patient-Centered Outcomes Research Institute 21st Century Cures Act 2.0 ---RFI from House Energy and Commerce Committee Diagnostics and Personalized Medicine Regulation and Oversight ---VALID Act (Discussion Draft House) Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---FDA Review of CBD-Based Drugs ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Innovation Incentives ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Regulatory Reform & Modernization ---S.660: Efficiency and Transparency in Petitions Act ---Use of Real-World Evidence Drug Importation ---General ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ---S.97: Affordable and Safe Prescription Drug Importation Act of 2019 ---S.771: Improving Access to Affordable Prescription Drugs Act of 2019 ---S.844: Short on Competition Act of 2019 ---S.Con.Res25: The FY 2018 Budget Resolution Drug Patenting ---H.R.19/S.3129: Lower Costs, More Cures Act of 2019 ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1188/S.366: Forcing Limits on Abusive and Tumultuous (FLAT) Prices Act ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.1503: Orange Book Transparency Act of 2019 ---H.R.1520: Purple Book Continuity Act of 2019 ---H.R.1865: Minibus which consists of the Fiscal Year 2020 Labor-Health and Human Services, Education, Defense, State-Foreign Operations, and Energy and Water Development appropriations bills ---H.R.3199 Terminating the Extension of Rights Misappropriated (TERM) Act of 2019 ---H.R.3991 Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 ---H.R.4398/S.1416: Affordable Prescriptions for Patients Act of 2019 ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 ---S.659: Biologic Patent Transparency Act of 2019 ---S.1416: Affordable Prescriptions for Patients Act of 2019 ---S.1617: Second Look at Drug Patents Act of 2019 ---S.1895: Lower Health Care Costs for Patients Act of 2019 Drug Pricing ---CMMI Authority ---General ---H.R.3: Lower Drug Costs Now Act of 2019 ---H.R.19/S.3129: Lower Costs, More Cures Act of 2019 ---H.R.275: Medicare Prescription Drug Price Negotiation Act of 2019 ---H.R.488/S.99: Medicare Drug Price Negotiation Act of 2019 ---H.R.965/S.340: CREATES Act of 2019 ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1093/S.378: Stop Price Gouging Act of 2019 ---H.R.1188/S.366: Forcing Limits on Abusive and Tumultuous Prices (FLAT) Prices Act of 2019 ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.1503: Orange Book Transparency Act of 2019 ---H.R.1520: Purple Book Continuity Act of 2019 ---H.R.1865: Minibus which consists of the Fiscal Year 2020 Labor-Health and Human Services, Education, Defense, State-Foreign Operations, and Energy and Water Development appropriations bills ---H.R.2069/S.474: Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 ---H.R.2113: Prescription Drug STAR Act of 2019 ---H.R.2376/S.1227: Prescription Pricing for the People Act of 2019 ---H.R.2387: STOP GAMES Act of 2019 ---H.R.3199 Terminating the Extension of Rights Misappropriated (TERM) Act of 2019 ---H.R.3991 Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 ---H.R.4398/S.1416: Affordable Prescriptions for Patients Act of 2019 ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---International Pricing Index Proposal ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) ---Pricing Transparency ---S.62: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019 ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 ---S.97: Affordable and Safe Prescription Drug Importation Act of 2019 ---S.476: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2019 ---S.771: Improving Access to Affordable Prescription Drugs Act of 2019 ---S.844: Short on Competition Act of 2019 ---S.1416: Affordable Prescriptions for Patients Act of 2019 ---S.1617: Second Look at Drug Patents Act of 2019 ---S.1895: Lower Health Care Costs for Patients Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---S.2911:Seniors Prescription Drug Relief Act of 2019 Funding for Antimicrobial Resistance Programs ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) Funding for FDA ---Aderholt Full Committee Amendment on Germline Editing ---Biotechnology and Agriculture Trade Program ---H.R.1158: Minibus which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development appropriations bills ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 Funding for Health Resources and Services Administration (HRSA) ---H.R.1865: Minibus which consists of the Fiscal Year 2020 Labor-Health and Human Services, Education, Defense, State-Foreign Operations, and Energy and Water Development appropriations bills ---Vaccine Injury Compensation Program (VICP) Funding for National Institutes of Health ---H.R.1865: Minibus which consists of the Fiscal Year 2020 Labor-Health and Human Services, Education, Defense, State-Foreign Operations, and Energy and Water Development appropriations bills ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.1865: Minibus which consists of the Fiscal Year 2020 Labor-Health and Human Services, Education, Defense, State-Foreign Operations, and Energy and Water Development appropriations bills Generic Drug Entry ---Access to Samples for Testing ---Generic Drug Application Review Reforms ---H.R.297: Increasing Competition in Pharmaceuticals Act of 2019 ---H.R.749: Lower Drug Costs Through Competition Act of 2018 ---H.R.938: Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019 ---H.R.965/S.340: CREATES Act of 2019 ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.2374/S.1224: Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics (STALLING) Act of 2019 ---Incentives for Generic Drug Entry ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 ---S.660: Efficiency and Transparency in Petitions Act International Biosecurity Policies Medicaid ---Alternative payment arrangements for gene therapies ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---S.3013: Encouraging Innovative Benefit Design to Lower Costs for Seniors Act Orphan Drug Issues ---Tax Credit Reimbursement and Coverage of Innovative Products ---Administration Rebate Rule ---CMMI Authority ---H.R.3: Lower Drug Costs Now Act of 2019 ---H.R.19/S.3129: Lower Costs, More Cures Act of 2019 ---H.R.488/S.99: Medicare Drug Price Negotiation Act of 2019 ---International Pricing Index Proposal ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Step Therapy ---Value-based Contracting and Communications The United States-Mexico-Canada Agreement ---IP Provisions US-China Trade Negotiations ---IP Provisions US-Japan Trade Agreement ---IP Provisions Vaccines and Infectious Diseases ---Executive Order on Modernizing Influenza Vaccines ---H.R.1973/S.1654: Vaccine Access Improvement Act of 2019 ---S.1872: Protecting Seniors through Immunizations Act of 2019 ---Vaccine and Anti-Microbial Resistance Product Development and Incentives

Client expense: $3,120,000 · Firm income: Not reported

S.474

CLAIRE BRANDEWIE DAVID LACHMANN HANSJORG SAUER HAYLEY ALEXANDER JAMIE GREGORIAN JEANNE HAGGERTY KYLE KUNKLER MICHAEL MATTOON SHEA HARTLEY THOMAS BRUNET mr CHARLES FRITTS mr MATTHEW O'MARA ms AIKEN HACKETT ms ELIZABETH ESHAM

Government targets: Centers For Medicare and Medicaid Services (CMS), Council of Economic Advisers (CEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office

GSK (FKA GLAXOSMITHKLINE INC.)client→GSK (FKA GLAXOSMITHKLINE INC.)

2019 · fourth_quarter · Health Issues

Open original LDA filing ↗

Cited source text, amounts, lobbyists, and targets

H.R. 447: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 478: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation H.R. 965: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 985: FAST Generics Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 1093: Stop Price Gouging Act - Provisions related to prescription drug pricing H.R. 1478: Affordable Insulin Act of 2019 - Provisions related to importation H.R. 1506: Fair and Immediate Release (FAIR) of Generic Drugs Act - Provisions related to generic prescription drug approvals H.R. 1922: Restoring Access to Medication Act of 2019 - Provisions related to prescription drug access H.R. 2064: To amend title XI of the Social Security Act to require manufacturers of certain drugs, devices, biologicals, and medical supplies to report on product samples provided to certain health care providers, and for other purposes - Provisions related to prescription drug samples H.R. 2069: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2019 - Provisions related to increases in the wholesale acquisition costs of prescription drugs H.R. 2087: Drug Price Transparency Act - Provisions related to prescription drug pricing and transparency H.R. 2113: Prescription Drug STAR Act - Provisions related to prescription drug pricing, reporting and product samples H.R. 2296: FAIR Drug Pricing Act of 2019 / More Efficient Tools to Realize Information for Consumers Act - Provisions related to prescription drug pricing and transparency H.R. 2376: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers H.R. 2734: Safer Prescribing of Controlled Substances Act - Provisions related to the prescribing of prescription drugs H.R. 3223: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers H.R. 3327: Drug Price Transparency for Medicare Patients Act of 2019 - Provisions related to direct-to-consumer prescription drug advertising H.R. 3415: Real-Time Beneficiary Drug Cost Bill - Provisions related to drug pricing transparency H.R. 3947: Competition Prescription Act of 2019 - Provisions related to prescription drug pricing, patents, and other provisions H.R. 4106: Responsibility in Drug Advertising Act of 2019 - Provisions related to direct-to-consumer prescription drug advertising H.R. 4158: CURE High Drug Prices Act - Provisions related to prescription drug pricing and transparency H.R. 4244: MAGIC Act - Provisions related to FDA approval pathways H.R. 4439: Creating Hope Reauthorization Act - Provisions related to rare disease priority review vouchers H.R. 4538: Closing Loopholes for Orphan Drugs Act - Provisions related to 340B prescription drug exclusions H.R. 4633: Investing in Safety and Innovation Act of 2019 - Provisions related to FDA programs reauthorization H.R. 4640: Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2019 - Provisions related to prescription drug pricing and negotiation H.R. 4667: Biomedical Innovation Expansion Act of 2019 - Provisions related to NIH programs reauthorization H.R. 4710: Pharmaceutical Independence Long-Term Readiness Reform Act - Provisions related to the supply chain H.R. 4711: No Tax Breaks for Drug Ads Act - Provisions related to direct-to-consumer prescription drug advertising H.R. 4812: Ensuring Compliance Against Drug Diversion Act of 2019 - Provisions related to registrations under the Controlled Substances Act H.R. 4866: National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2019 - Provisions related to designation of universities as centers of excellence supporting manufacturing H.R. 4963: Stop the Importation and Manufacturing of Synthetic Analogues Act of 2019 - Provisions related to synthetic analogues H.R. 5031: Medical Innovation Act of 2019 - Provisions related to prescription drug manufacturer taxation and supplemental fees H.R. 5198: Patients' Right to Know Their Medication Act of 2019 - Provisions related to prescription drug labeling H.R. 5239: Prescription Drug Price Reporting Act - Provisions related to prescription drug pricing transparency H.R. 5304: PBM Transparency in Prescription Drug Costs Act - Provisions related to prescription drug pricing transparency H.R. 5381: International Pharmaceutical Transparency Act of 2019 - Provisions related to prescription drug labeling H.R. 5442: To amend title XXVII of the Public Health Service Act and title XVIII of the Social Security Act to require pharmacies to disclose any differential between the cost of a prescription drug based on whether certain individuals use prescription drug coverage to acquire such drug, and for other purposes. - Provisions related to prescription drug pricing and transparency H.R. 5497: Conditional Approval Act - Provisions related to approval pathway S. 61: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation S. 73: End Taxpayer Subsidies for Drug Ads Act - Provisions related to direct-to-consumer prescription drug advertising S. 97: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 340: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 378: Stop Price Gouging Act - Provisions related to prescription drug pricing S. 474: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2019 - Provisions related to increases in the wholesale acquisition costs of prescription drugs S. 637: Combatting Unreasonable Rises and Excessively (CURE) High Drug Prices Act - Provisions related to prescription drug pricing and transparency S. 657: Drug Price Transparency Act - Provisions related to prescription drug pricing transparency and commercial market rebates S. 658: Accelerated Drug Approval for Prescription Therapies Act - Provisions related to FDA drug approvals S. 660: Efficiency and Transparency in Petitions Act - Provisions related to the FDA citizen petition process S. 1140: Protecting Access to Biosimilars Act of 2019 - Provisions related to biological products S. 1227: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 1250: American Cures Act - Provisions related to pharmaceutical research and development S. 1391: FAIR Drug Pricing Act of 2019 - Provisions related to prescription drug pricing and transparency S. 1437: Drug-price Transparency in Communications (DTC) Act - Provisions related to direct-to-consumer prescription drug advertising S. 1532: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 2004: Emergency Access to Insulin Act of 2019 - Provisions related to prescription drug pricing S. 2161: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 - Provisions related to reciprocity S. 2723: Mitigating Emergency Drug Shortages Act - Provisions related to prescription drug pricing transparency and other provisions S. 2897: Patient-Centered Outcomes Research Institute Reauthorization Act - Provisions related to PCORI reauthorization Transparency policy issues Drug cost and pricing policy issues Drug importation and counterfeiting policy issues HHS Safe Importation Action Plan Prescription drug take back and secure disposal policy issues Policy issues related to prescription drug abuse and opioids Expanded access policy issues Generic drug approval process policy issues High deductible health plans/HSA policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues FDA modernization policy issues PDUFA implementation policy issues 340B drug discount program policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions Patient assistance program policy issues Foreign manufacturing policy issues Biosimilar approval and reimbursement policy issues Drug compounding policy issues including federal oversight of compounded drugs Cancer drug vial size policy issues TRICARE pharmacy pilot program Drug shortages policy issues Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49) Proposed Rule; Importation of Prescription Drugs (RIN 0910-AI45) Monograph Reform, HSA/FSAs S 2740 - Over-the-Counter Monograph Safety S1872/HR5076, Protecting Seniors Through Immunization Act S1654/HR1973, Vaccine Access Improvement Act

Client expense: $700,000 · Firm income: Not reported

S. 474

JENNIFER DALE MICHAEL CALVO PHILIP THEVENET mr ALEC HINOJOSA mr WILLIAM SCHUYLER ms KIMBERLY WILLIAMS

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)

AMERICA'S HEALTH INSURANCE PLANS, INC. (AHIP)client→AMERICA'S HEALTH INSURANCE PLANS, INC. (AHIP)

2019 · fourth_quarter · Pharmacy

Open original LDA filing ↗

Cited source text, amounts, lobbyists, and targets

S. 61, Safe and Affordable Drugs from Canada Act (Grassley) - drug importation S. 64, Preserve Access to Affordable Generics and Biosimilars Act (Grassley-Klobuchar) - prohibiting pay-for-delay settlements S. 73, End Taxpayer Subsidies for Drug Ads Act (Shaheen) - prohibiting tax deduction for DTC advertising expenses S. 102, Prescription Drug Price Relief Act (Sanders) - reforms linked to international pricing S. 340, CREATES Act (Leahy) - removing barriers to generic drugs S. 344, Hatch-Waxman Integrity Act (Tillis) - inter partes review process S. 366, FLAT Prices Act (Durbin) - reforms for drugs with sudden price spikes S. 378, Stop Price Gouging Act (Durbin) - excise tax for drugs that have price spikes S. 440, Preserving Access to Cost-Effective Drugs Act (Cotton) - sovereign immunity and Inter Partes Review process S. 474, SPIKE Act (Wyden) - justification for drug price increases S. 476, Creating Transparency to Have Drug Rebates Unlocked Act (Wyden) - drug price transparency S. 637, CURE High Drug Prices Act (Blumenthal) - remedies for price gouging S. 657, Point of Sale Rebates (Braun) S. 659, Biologic Patent Transparency Act (Collins) - patent disclosure requirements S. 660, Efficiency and Transparency in Petitions Act (Braun) - FDA citizen petition process S. 844, Short on Competition Act (Klobuchar) - remedies for marginally competitive drug markets S. 977, Transparency Drug Pricing Act (Scott) - transparency and drug pricing reforms S. 1209, Reforming Evergreening and Manipulation that Extends Drug Years Act (Cassidy) - preventing evergreening of patent protections S. 1224, Stop STALLING Act (Klobuchar) - citizen petition process S. 1227, Prescription Pricing for the People Act (Grassley) - FTC report on role of PBMs and allegations of anticompetitive conduct by manufacturers of sole-source drugs S. 1384, Prescription Drug Rebate Reform Act (Romney-Braun) - prescription drug cost sharing S. 1416, Affordable Prescriptions for Patients Act (Cornyn) - product hopping, patent thickets S. 1664, Prescription Drug Price Reporting Act (Scott) - prescription drug price reporting S. 2247, Phair Relief Act of 2019 (Kennedy)-transparency around price concessions for drugs S. 2387, We Protect American Investment in Drugs Act (Van Hollen)-drug pricing S. 2543, Prescription Drug Pricing Reduction Act of 2019 (Grassley)-Drug pricing S. 2740, Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019 (Isakson) - regulations re nonprescription drugs that are marketed without an approved new drug application S. 3052, United States-Mexico-Canada Agreement Implementation Act (Grassley) - drug pricing S. 3067, Non-Opioids Prevent Addiction In the Nation Act (Capito) - non-opioid treatments S. 3092, Expanding Access to Low-Cost Generics Act of 2019 (Smith) - exclusivity period H.R. 3, Lower Drug Costs Now Act of 2019 (Pallone)-drug pricing H.R. 465, Prescription Drug Price Relief Act (Khanna) - reforms linked to international pricing H.R. 478, Safe and Affordable Drugs from Canada Act (Pingree) - drug importation H.R. 938, BLOCKING Act (Schrader) - changes to 180-day period of market exclusivity for first generic applicant H.R. 965, CREATES Act (Cicilline) - removing barriers to generic drugs H.R. 985, FAST Generics Act (Welch) - removing barriers to generic drugs H.R. 990, Hatch-Waxman Integrity Act (Flores) - inter partes review process H.R. 1093, Stop Price Gouging Act (Pocan) - excise tax for drugs that have price spikes H.R. 1188, FLAT Prices Act (Golden) - reforms for drugs with sudden price spikes H.R. 1344, Competitive DRUGS Act (Doggett) - prohibiting pay-for-delay agreements H.R. 1419, Public Option Deficit Reduction Act (DeFazio) - public option H.R. 1499, Protecting Consumer Access to Generic Drugs Act (Rush) - prohibiting pay-for-delay agreements H.R. 1503, Orange Book Transparency Act (Kelly) - removal of invalidated patents from Orange Book H.R. 1506, FAIR Generics Act (Barragan) - changes to 180-day period of market exclusivity for first generic applicant H.R. 1520, Purple Book Continuity Act (Eshoo) - access to updated information on biologics and biosimilars H.R. 2038, State-Based, Market-Oriented Prescription Drug Negotiations Act (Meadows) - drug price negotiations H.R. 2064, Sunshine for Samples Act (Chu) - reporting requirements on drug samples H.R. 2069, SPIKE Act (Horsford) -justification for drug price increases H.R. 2087, Drug Price Transparency Act (Doggett) - reporting of drug pricing data under Medicare Part B H.R. 2113, Prescription Drug Sunshine, Transparency, Accountability and Reporting Act (Neal) - transparency in drug pricing H.R. 2115, Public Disclosure of Drug Discounts Act (Spanberger) - disclosure of negotiated Rx discounts H.R. 2279, Safe Step Act (Ruiz) - exceptions process for medication step therapy H.R. 2296, FAIR Drug Pricing Act (Schakowsky) - transparency requirements and justification for high list prices and drug price increases H.R. 2374, Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act (Jeffries) - citizen petition process H.R. 2375, Preserve Access to Affordable Generics and Biosimilars Act (Nadler) - prohibiting pay-for-delay agreements H.R. 2376, Prescription Pricing for the People Act (Collins) - FTC study on role of PBMs and competition and transparency in pharmaceutical supply chain H.R. 3379, Price Relief, Innovation, and Competition for Essential Drugs Act (Schakowsky) - exclusivity period for biological products H.R. 3805, Prescription Drug Rebate Reform Act of 2019 (Gallagher)- drug rebates H.R. 3927, PDMPs Help Patients Act of 2019 (McKinley)-integrating SUDs and behavioral health into PDMPs H.R. 3947, Competition Prescription Act of 2019 (Meadows)- drug pricing H.R. 4010, Emergency Access to Insulin Act of 2019 (Craig)- drug pricing H.R. 4106, Responsibility in Drug Advertising Act of 2019 (DeLauro)-transparency in drug pricing H.R. 4244, MAGIC Act (Kelly)-pathways for insulin approval H.R. 4398, Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 (Cicilline)-drug pricing H.R. 4455, BIOSIM Act (Schrader)-access to biosimilars H.R. 4460, Turn the Tide Act (Kuster)-Opioids H.R. 4538, Closing Loopholes for Orphan Drugs Act (Welch)-Access to drugs H.R. 4640, Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2019 (DeFazio) - direct negotiation H.R. 4712, Fairness in Orphan Drug Exclusivity Act (Dean) - limitations on exclusive approval of orphan drugs H.R. 4810, Opioid Prescription Verification Act of 2019 (David) - dispensing of controlled substances H.R. 4906, Insulin Price Reduction Act (Diana DeGette) - insulin costs H.R. 5304, PBM Transparency in Prescription Drug Costs Act (Schrader) - PBMs H.R. 5364, End Price Gouging for Insulin Act (Beatty) - annual reference price for insulin products H.R. 5430, United States-Mexico-Canada Agreement Implementation Act (Hoyer) - drug pricing H.R. 5442, Lowest Price for Patients Act (Porter) - pharmacies to disclose any differential between the cost of a prescription drug H.R. 5444, Lower Insulin Costs Now Act (Underwood) - lowering insulin costs H.Con.Res. 55, Expressing the sense of Congress on the need to inform American consumers with more balanced purchasing information for prescription drugs through the disclosure of price information in direct-to-consumer (DTC) advertisements. (Burgess)-drug pricing Regulatory Issues: Issues relating to long term safety and effectiveness of medical devices and drugs, including registries; issues relating to post-market surveillance of drugs and medical devices; issues relating to price of drugs and biologics and proposals to limit high prices; issues related to drug patents and market exclusivity; issues related to pharmacy benefit managers; issues related to biosimilars; issues related to approval of drugs and biologics; issues relating to opioids; issues relating to prescription drug rebates; issues relating to prescription drug price blueprint; direct-to-consumer advertising for prescription drugs; issues related to proposed changes to removal of safe harbor protection for rebates (proposed rule); issues relating to access for investigational drugs; and other issues relating to health care reform implementation.

Client expense: $2,340,000 · Firm income: Not reported

S. 474

ARON GRIFFIN CHRISTOPHER ANDERSON DANIEL NAM ELIZABETH GOODMAN GREGORY BERGER GREGORY GIERER JEANETTE THORNTON KATHLEEN CALLANAN KATIE ALLEN KEITH FONTENOT LAUREN OLIVER MARK HAMELBURG MATTHEW EYLES RHYS JONES SEAN DUGAN

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, Treasury, Dept of, White House Office

BIOTECHNOLOGY INNOVATION ORGANIZATIONclient→BIOTECHNOLOGY INNOVATION ORGANIZATION

2019 · fourth_quarter · Health Issues

Open original LDA filing ↗

Cited source text, amounts, lobbyists, and targets

340B Drug Discount Program ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Antibiotic & Diagnostic Tax Credit Biodefense Research, Development and Procurement Issues (Non-funding) ---Executive Order on Modernizing Influenza Vaccines ---Gene Editing ---H.R.269/S.1379: Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 ---Implementation of Medical Countermeasures Innovation Act ---Implementation of the 21st Century Cures Act of 2016 ---Implementation of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act (PAHPAI) of 2019 ---National Biodefense Strategy ---Pandemic Influenza Preparedness ---Tropical Disease Priority Review Voucher (PRV) Program Biosimilars ---Access to Samples for Testing ---Biosimilar Copay Elimination ---Brazil Biologics Regulations ---Canada Biologics Regulations ---Coding ---H.R.965/S.340: CREATES Act of 2019 ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.1520: Purple Book Continuity Act of 2019 ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 ---India Biologics Regulations ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---Reimbursement ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 ---S.659: Biologic Patent Transparency Act of 2019 Climate Change ---RFI from House Select Committee on the Climate Crisis Comparative Effectiveness Research Initiatives ---Reauthorization of Patient-Centered Outcomes Research Institute 21st Century Cures Act 2.0 ---RFI from House Energy and Commerce Committee Diagnostics and Personalized Medicine Regulation and Oversight ---VALID Act (Discussion Draft House) Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---FDA Review of CBD-Based Drugs ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Innovation Incentives ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Regulatory Reform & Modernization ---S.660: Efficiency and Transparency in Petitions Act ---Use of Real-World Evidence Drug Importation ---General ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ---S.97: Affordable and Safe Prescription Drug Importation Act of 2019 ---S.771: Improving Access to Affordable Prescription Drugs Act of 2019 ---S.844: Short on Competition Act of 2019 ---S.Con.Res25: The FY 2018 Budget Resolution Drug Patenting ---H.R.19/S.3129: Lower Costs, More Cures Act of 2019 ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1188/S.366: Forcing Limits on Abusive and Tumultuous (FLAT) Prices Act ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.1503: Orange Book Transparency Act of 2019 ---H.R.1520: Purple Book Continuity Act of 2019 ---H.R.1865: Minibus which consists of the Fiscal Year 2020 Labor-Health and Human Services, Education, Defense, State-Foreign Operations, and Energy and Water Development appropriations bills ---H.R.3199 Terminating the Extension of Rights Misappropriated (TERM) Act of 2019 ---H.R.3991 Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 ---H.R.4398/S.1416: Affordable Prescriptions for Patients Act of 2019 ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 ---S.659: Biologic Patent Transparency Act of 2019 ---S.1416: Affordable Prescriptions for Patients Act of 2019 ---S.1617: Second Look at Drug Patents Act of 2019 ---S.1895: Lower Health Care Costs for Patients Act of 2019 Drug Pricing ---CMMI Authority ---General ---H.R.3: Lower Drug Costs Now Act of 2019 ---H.R.19/S.3129: Lower Costs, More Cures Act of 2019 ---H.R.275: Medicare Prescription Drug Price Negotiation Act of 2019 ---H.R.488/S.99: Medicare Drug Price Negotiation Act of 2019 ---H.R.965/S.340: CREATES Act of 2019 ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1093/S.378: Stop Price Gouging Act of 2019 ---H.R.1188/S.366: Forcing Limits on Abusive and Tumultuous Prices (FLAT) Prices Act of 2019 ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.1503: Orange Book Transparency Act of 2019 ---H.R.1520: Purple Book Continuity Act of 2019 ---H.R.1865: Minibus which consists of the Fiscal Year 2020 Labor-Health and Human Services, Education, Defense, State-Foreign Operations, and Energy and Water Development appropriations bills ---H.R.2069/S.474: Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 ---H.R.2113: Prescription Drug STAR Act of 2019 ---H.R.2376/S.1227: Prescription Pricing for the People Act of 2019 ---H.R.2387: STOP GAMES Act of 2019 ---H.R.3199 Terminating the Extension of Rights Misappropriated (TERM) Act of 2019 ---H.R.3991 Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 ---H.R.4398/S.1416: Affordable Prescriptions for Patients Act of 2019 ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---International Pricing Index Proposal ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) ---Pricing Transparency ---S.62: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019 ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 ---S.97: Affordable and Safe Prescription Drug Importation Act of 2019 ---S.476: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2019 ---S.771: Improving Access to Affordable Prescription Drugs Act of 2019 ---S.844: Short on Competition Act of 2019 ---S.1416: Affordable Prescriptions for Patients Act of 2019 ---S.1617: Second Look at Drug Patents Act of 2019 ---S.1895: Lower Health Care Costs for Patients Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---S.2911:Seniors Prescription Drug Relief Act of 2019 Funding for Antimicrobial Resistance Programs ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) Funding for FDA ---Aderholt Full Committee Amendment on Germline Editing ---Biotechnology and Agriculture Trade Program ---H.R.1158: Minibus which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development appropriations bills ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 Funding for Health Resources and Services Administration (HRSA) ---H.R.1865: Minibus which consists of the Fiscal Year 2020 Labor-Health and Human Services, Education, Defense, State-Foreign Operations, and Energy and Water Development appropriations bills ---Vaccine Injury Compensation Program (VICP) Funding for National Institutes of Health ---H.R.1865: Minibus which consists of the Fiscal Year 2020 Labor-Health and Human Services, Education, Defense, State-Foreign Operations, and Energy and Water Development appropriations bills ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.1865: Minibus which consists of the Fiscal Year 2020 Labor-Health and Human Services, Education, Defense, State-Foreign Operations, and Energy and Water Development appropriations bills Generic Drug Entry ---Access to Samples for Testing ---Generic Drug Application Review Reforms ---H.R.297: Increasing Competition in Pharmaceuticals Act of 2019 ---H.R.749: Lower Drug Costs Through Competition Act of 2018 ---H.R.938: Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019 ---H.R.965/S.340: CREATES Act of 2019 ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.2374/S.1224: Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics (STALLING) Act of 2019 ---Incentives for Generic Drug Entry ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 ---S.660: Efficiency and Transparency in Petitions Act International Biosecurity Policies Medicaid ---Alternative payment arrangements for gene therapies ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---S.3013: Encouraging Innovative Benefit Design to Lower Costs for Seniors Act Orphan Drug Issues ---Tax Credit Reimbursement and Coverage of Innovative Products ---Administration Rebate Rule ---CMMI Authority ---H.R.3: Lower Drug Costs Now Act of 2019 ---H.R.19/S.3129: Lower Costs, More Cures Act of 2019 ---H.R.488/S.99: Medicare Drug Price Negotiation Act of 2019 ---International Pricing Index Proposal ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Step Therapy ---Value-based Contracting and Communications The United States-Mexico-Canada Agreement ---IP Provisions US-China Trade Negotiations ---IP Provisions US-Japan Trade Agreement ---IP Provisions Vaccines and Infectious Diseases ---Executive Order on Modernizing Influenza Vaccines ---H.R.1973/S.1654: Vaccine Access Improvement Act of 2019 ---S.1872: Protecting Seniors through Immunizations Act of 2019 ---Vaccine and Anti-Microbial Resistance Product Development and Incentives

Client expense: $3,120,000 · Firm income: Not reported

S.474

CLAIRE BRANDEWIE DAVID LACHMANN HANSJORG SAUER HAYLEY ALEXANDER JAMIE GREGORIAN JEANNE HAGGERTY KYLE KUNKLER MICHAEL MATTOON SHEA HARTLEY THOMAS BRUNET mr CHARLES FRITTS mr MATTHEW O'MARA ms AIKEN HACKETT ms ELIZABETH ESHAM

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Council of Economic Advisers (CEA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICAclient→PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA

2019 · fourth_quarter · Health Issues

Open original LDA filing ↗

Cited source text, amounts, lobbyists, and targets

H.R. 447: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 478: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation H.R. 965: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 985: FAST Generics Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 1093: Stop Price Gouging Act - Provisions related to prescription drug pricing H.R. 1478: Affordable Insulin Act of 2019 - Provisions related to importation H.R. 1506: Fair and Immediate Release (FAIR) of Generic Drugs Act - Provisions related to generic prescription drug approvals H.R. 1922: Restoring Access to Medication Act of 2019 - Provisions related to prescription drug access H.R. 2064: To amend title XI of the Social Security Act to require manufacturers of certain drugs, devices, biologicals, and medical supplies to report on product samples provided to certain health care providers, and for other purposes - Provisions related to prescription drug samples H.R. 2069: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2019 - Provisions related to increases in the wholesale acquisition costs of prescription drugs H.R. 2087: Drug Price Transparency Act - Provisions related to prescription drug pricing and transparency H.R. 2113: Prescription Drug STAR Act - Provisions related to prescription drug pricing, reporting and product samples H.R. 2296: FAIR Drug Pricing Act of 2019 / More Efficient Tools to Realize Information for Consumers Act - Provisions related to prescription drug pricing and transparency H.R. 2376: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers H.R. 2569: Comprehensive Addiction Resources Emergency Act of 2019 - Provisions related to opioid crisis response funding H.R. 2732: Lessening Addiction By Enhancing Labeling Opioids Act of 2019 - Provisions related to labeling of prescription drugs H.R. 2734: Safer Prescribing of Controlled Substances Act - Provisions related to the prescribing of prescription drugs H.R. 2917: Opioid Crisis Accountability Act of 2019 - Provisions related to prescription drug marketing H.R. 3223: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers H.R. 3327: Drug Price Transparency for Medicare Patients Act of 2019 - Provisions related to direct-to-consumer prescription drug advertising H.R. 3415: Real-Time Beneficiary Drug Cost Bill - Provisions related to drug pricing transparency H.R. 3947: Competition Prescription Act of 2019 - Provisions related to prescription drug pricing, patents, and other provisions H.R. 4010: Emergency Access to Insulin Act of 2019 - Provisions related to prescription drug access programs H.R. 4106: Responsibility in Drug Advertising Act of 2019 - Provisions related to direct-to-consumer prescription drug advertising H.R. 4158: CURE High Drug Prices Act - Provisions related to prescription drug pricing and transparency H.R. 4439: Creating Hope Reauthorization Act - Provisions related to rare disease priority review vouchers H.R. 4538: Closing Loopholes for Orphan Drugs Act - Provisions related to 340B prescription drug exclusions H.R. 4633: Investing in Safety and Innovation Act of 2019 - Provisions related to FDA programs reauthorization H.R. 4640: Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2019 - Provisions related to prescription drug pricing and negotiation H.R. 4667: Biomedical Innovation Expansion Act of 2019 - Provisions related to NIH programs reauthorization H.R. 4710: Pharmaceutical Independence Long-Term Readiness Reform Act - Provisions related to the supply chain H.R. 4711: No Tax Breaks for Drug Ads Act - Provisions related to direct-to-consumer prescription drug advertising H.R. 4812: Ensuring Compliance Against Drug Diversion Act of 2019 - Provisions related to registrations under the Controlled Substances Act H.R. 4814: Suspicious Order Identification Act of 2019 - Provisions related to reporting on distribution of controlled substances H.R. 4906: Insulin Price Reduction Act - Provisions related to prescription drug pricing and transparency H.R. 4963: Stop the Importation and Manufacturing of Synthetic Analogues Act of 2019 - Provisions related to synthetic analogues H.R. 5031: Medical Innovation Act of 2019 - Provisions related to prescription drug manufacturer taxation and supplemental fees H.R. 5198: Patients' Right to Know Their Medication Act of 2019 - Provisions related to prescription drug labeling H.R. 5239: Prescription Drug Price Reporting Act - Provisions related to prescription drug pricing transparency H.R. 5304: PBM Transparency in Prescription Drug Costs Act - Provisions related to prescription drug pricing transparency H.R. 5381: International Pharmaceutical Transparency Act of 2019 - Provisions related to prescription drug labeling H.R. 5382: To create a mechanism whereby insulin manufacturers may sell directly to consumers at current net prices - Provisions related to prescription drug pricing H.R. 5442: To amend title XXVII of the Public Health Service Act and title XVIII of the Social Security Act to require pharmacies to disclose any differential between the cost of a prescription drug based on whether certain individuals use prescription drug coverage to acquire such drug, and for other purposes - Provisions related to prescription drug pricing and transparency H.R. 5497: Conditional Approval Act - Provisions related to approval pathway S. 61: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation S. 73: End Taxpayer Subsidies for Drug Ads Act - Provisions related to direct-to-consumer prescription drug advertising S. 97: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 340: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 378: Stop Price Gouging Act - Provisions related to prescription drug pricing S. 474: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2019 - Provisions related to increases in the wholesale acquisition costs of prescription drugs S. 637: Combatting Unreasonable Rises and Excessively (CURE) High Drug Prices Act - Provisions related to prescription drug pricing and transparency S. 657: Drug Price Transparency Act - Provisions related to prescription drug pricing transparency and commercial market rebates S. 660: Efficiency and Transparency in Petitions Act - Provisions related to the FDA citizen petition process S. 1140: Protecting Access to Biosimilars Act of 2019 - Provisions related to biological products S. 1227: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 1250: American Cures Act - Provisions related to pharmaceutical research and development S. 1391: FAIR Drug Pricing Act of 2019 - Provisions related to prescription drug pricing and transparency S. 1437: Drug-price Transparency in Communications (DTC) Act - Provisions related to direct-to-consumer prescription drug advertising S. 1532: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 2004: Emergency Access to Insulin Act of 2019 - Provisions related to prescription drug pricing S. 2103: Affordable Insulin Approvals Now Act - Provisions related to FDA prescription drug approvals S. 2161: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 - Provisions related to reciprocity S. 2199: Insulin Price Reduction Act - Provisions related to prescription drug pricing and transparency S. 2723: Mitigating Emergency Drug Shortages Act - Provisions related to prescription drug pricing transparency and other provisions S. 2897: Patient-Centered Outcomes Research Institute Reauthorization Act - Provisions related to PCORI reauthorization Transparency policy issues Drug cost and pricing policy issues Drug importation and counterfeiting policy issues HHS Safe Importation Action Plan Prescription drug take back and secure disposal policy issues Policy issues related to prescription drug abuse and opioids Expanded access policy issues Generic drug approval process policy issues High deductible health plans/HSA policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues FDA modernization policy issues PDUFA implementation policy issues 340B drug discount program policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions Patient assistance program policy issues Foreign manufacturing policy issues Biosimilar approval and reimbursement policy issues Drug compounding policy issues including federal oversight of compounded drugs Cancer drug vial size policy issues TRICARE pharmacy pilot program Drug shortages policy issues Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49) Proposed Rule; Importation of Prescription Drugs (RIN 0910-AI45)

Client expense: $6,450,000 · Firm income: Not reported

S. 474

ANNE PRITCHETT BART FORSYTH BRIDGETT TAYLOR COLLEEN MALONEY DAVID KORN ERIN HERMANCE ERIN MENDELSOHN JAMES STANSEL LISA JOLDERSMA LORI REILLY MATTHEW STURM NATALIE BURKHALTER NICK SHIPLEY NICOLAS MAGALLANES RANDY BURKHOLDER RYAN KAAT SHANNON STEHOUWER TERESA BILL

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)

NOVARTISclient→NOVARTIS

2019 · fourth_quarter · Health Issues

Open original LDA filing ↗

Cited source text, amounts, lobbyists, and targets

S.2543 - Prescription Drug Pricing Reduction Act of 2019 H.R.5997 - Ensuring Patient Access to Critical Breakthrough Products Act of 2018 HR 938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics Act HR 1520: Purple Book Continuity Act HR 1503: Orange Book Transparency Act HR 1499: Protecting Consumer Access to Generic Drugs Act HR 2113:Speeding Access to Already Approved Pharmaceuticals Act of 2017 HR 5997:Ensuring Patient Access to Critical Breakthrough Products Act of 2018 Senate SPIKE Act Fast Generics Cell & Gene Therapy, including reimbursement 340B Drug Discount Program Drug Importation REMS Creates Act Drug Cost/Pricing Biosimilars Reimbursement Outcomes based Contracting Part D Non-interference Orphan Drugs Virtual Clinical Trials Part D Benefit Redesign Biosimilar Pass Through Payments Value Based Pricing USMCA Medicaid Payment Reform AMP Cap Labor HHS Appropriations S 1895 - Lower Health Care Costs Act HR 987 - Strengthening Health Care and Lowering Prescription Drug Costs Act H.R.478 - Safe and Affordable Drugs from Canada Act of 2019 H.R.965 - CREATES Act of 2019 H.R.985 - FAST Generics Act of 2019 H.R.1093 - Stop Price Gouging Act H.R.1332 - Fair Care Act of 2019 H.R.1506 - FAIR Generics Act H.R.2011 - Protecting Access to Biosimilars Act of 2019 H.R.2069 - SPIKE Act H.R.2087 - Drug Price Transparency Act H.R.2113 - Prescription Drug STAR Act H.R.2296 - FAIR Drug Pricing Act of 2019 H.R.3327 - Drug Price Transparency for Medicare Patients Act of 2019 H.R.3408 - EXEMPT Act S.61 - Safe and Affordable Drugs from Canada Act of 2019 S.340 - CREATES Act of 2019 S.474 - Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 S.1140 - Protecting Access to Biosimilars Act of 2019 S.1384 - Prescription Drug Rebate Reform Act of 2019 S.1391 - Fair Accountability and Innovative Research Drug Pricing Act of 2019 S.1437 - Drug-price Transparency in Communications (DTC) Act S.1224 - Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act (Stop STALLING Act) S.1227 - Prescription Pricing for the People Act of 2019 H.R.447 - Affordable and Safe Prescription Drug Importation Act H.R.1922 - Restoring Access to Medication Act of 2019 H.R.2064 - To amend title XI of the Social Security Act to require manufacturers of certain drugs, devices, biologicals, and medical supplies to report on product samples provided to certain health care providers, and for other purposes H.R.4633 - Investing in Safety and Innovation Act of 2019 H.R.5239 - Prescription Drug Price Reporting Act H.R.5304 - PBM Transparency in Prescription Drug Costs Act S.97 - Affordable and Safe Prescription Drug Importation Act S.657 - A bill to amend title XXVII of the Public Health Service Act to establish requirements with respect to prescription drug benefits Transparency policy issues Drug cost and pricing policy issues Drug importation and counterfeiting policy issues HHS Safe Importation Action Plan Expanded access policy issues Generic drug approval process policy issues Risk Evaluation and Mitigation Strategy (REMS) policy issues PDUFA implementation policy issues 340B drug discount program policy issues Cancer drug vial size policy issues

Client expense: $620,000 · Firm income: Not reported

S.474

DANIEL CASSERLY JOSEPH MCGOWAN LEO FARBER NORA CONNORS SARAH HALLER SHELLY MUI-LIPNIK TAYLOR BOOTH

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office

AARPclient→AARP

2019 · fourth_quarter · Pharmacy

Open original LDA filing ↗

Cited source text, amounts, lobbyists, and targets

H.R. 1158/H.R. 1865 - The Consolidated Appropriations Act/Further Consolidated Appropriations Act. H.R. 3055/S.2584 Commerce, Justice, Science, Agriculture, Rural Development, FDA, Interior Environment, Military Construction, VA,Transportation, Housing and Urban Development Appropriations Act, FY 2020. S. 340/H.R. 965 - CREATES Act. H.R. 1499 Preserving Consumer Access to Generic Drugs Act. S.64/H.R. 2375 - the Preserve Access to Generics and Biosimilars Act. H.R. 2113 - the Prescription STAR Act. H.R. 2296/S.1391 - The FAIR Drug Pricing Act. S.1416 - the Affordable Prescriptions for Patients Act. S.1437, the Drug-price Transparency in Communications (DTC) Act. S.551, the REFUND Act. S.1209, the REMEDY Act. S. 474/H.R. 2069, the SPIKE Act. Discussed Part D price negotiation and out-of-pocket cap with House and Senate. Discussed proposed Anti-Kickback rule. Discussed importation. Discussed international reference pricing. Discussed H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act of 2019 and H.R. 1682, the Improving Access to Medicare Coverage Act. No bill number and H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act of 2019, discussed prescription drug legislation with House staff. S.2543 the Prescription Drug Pricing Reduction Act (Grassley-Wyden bill). No bill number. Provided feedback on long-term care pharmacy bill.

Client expense: $2,140,000 · Firm income: Not reported

S. 474

AMY KELBICK BEVERLY GILYARD BLAKE KELLY DAVID CERTNER DENISE DEMICHELE-BAILIN FERNANDO RUIZ JOHN HISHTA LEIGH PURVIS MEGAN O'REILLY NANCY LEAMOND NICOLE BURDA RHONDA RICHARDS TIMOTHY GEARAN WILLIAM SWEENEY mr JOHN CUMMINGS jr ms SHANNON RUSSELL

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Housing & Urban Development, Dept of (HUD), Internal Revenue Service (IRS), Labor, Dept of (DOL), Office of Management & Budget (OMB), Office of Personnel Management (OPM), Pension Benefit Guaranty Corporation (PBGC), SENATE, Securities & Exchange Commission (SEC), Transportation, Dept of (DOT), Treasury, Dept of, White House Office