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Fairness in Orphan Drug Exclusivity Act
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Momentum (last 30 days)
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398d open
vs 9,062 other HR bills in the 116th — cohort avg 39d
Fairness in Orphan Drug Exclusivity Act This bill limits which orphan drugs may be granted a market exclusivity period by the Food and Drug Administration (FDA). (Generally, an orphan drug is one that is not economically viable because of the rarity of the disease that it treats; the sponsor of an FDA-designated orphan drug may be granted various incentives, such as a seven-year period in which the FDA may not grant market approval to a different sponsor for the same drug to treat the same disease.) Under this bill, if a drug is designated as an orphan drug on the basis that there is no reasonable expectation that the sponsor will recover the costs of developing and distributing the drug from U.S. sales, the drug shall be granted the seven-year exclusivity period only if the sponsor demonstrates that there is no reasonable expectation that it will recover such costs specifically within its first 12 years of U.S. sales of the drug. This requirement shall also apply retroactively to an orphan drug that was granted such an exclusivity period before this bill's enactment. When deciding whether an orphan drug meets this requirement, the FDA shall consider the sales of all drugs from the sponsor that are covered by the same orphan drug designation.
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Filing registrants (20)
Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Motion to reconsider laid on the table Agreed to without objection.
On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H5807)
Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote.(text: CR H5807)
DEBATE - The House proceeded with forty minutes of debate on H.R. 4712.
Considered under suspension of the rules. (consideration: CR H5807-5809)
Mr. Pallone moved to suspend the rules and pass the bill, as amended.
Placed on the Union Calendar, Calendar No. 470.
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 116-572.
Congress.gov source codes: 5000, H12200
Bills with similar content found using semantic analysis.
Sources: Congress.gov
2021 · first_quarter · Health Issues
Regulatory exclusivity; Drug pricing; Medicare Part B international reference pricing; Generic drug competition; Drug patent issues; Affordable Prescriptions for Patients Act of 2019 (S. 1416); Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 (H.R. 5133/H.R. 4398); H.R. 3991 - Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019; Executive Order 13944 (List of Essential Medicines, Medical Countermeasures, and Critical Inputs); Executive Order 14001 on a Sustainable Public Health Supply Chain; Compulsory licensing; Real world evidence; National Defense Authorization Act for Fiscal Year 2021 (S. 4049); S.Res.625 - A resolution encouraging the Government and the people of the United States to "Buy American"; Executive Order 13922; Executive Order 13911; Executive Order 13938; Domestic manufacturing incentives; Potential amendments to PREP Act; Bring Entrepreneurial Advancements To Consumers Here In North America Act (H.R. 6690); Bayh-Dole Act; Learnings from Pandemic; Safe Authorization for Vaccines during Emergencies Act (S.4427); Executive Order 13948 (Lowering Drug Prices by Putting America First); Advancing Americas Interests Act (H.R. 8037); Safeguarding American Innovation Act (S. 3997); Safe to Work Act (S. 4317); 340B drug discounts; Executive Order 13962 (Ensuring Access to United States Government COVID-19 Vaccines); antitrust reform proposals; Competition and Antitrust Law Enforcement Reform Act (S. 225); Pioneering Antimicrobial Subscriptions To End Up surging Resistance Act of 2020 (S. 4760/H.R. 8920); Lower Health Care Costs Act (S. 1895); Protecting Our Pharmaceutical Supply Chain from China Act of 2020 (H.R. 6482); Part D non-interference; Ensuring Innovation Act (S.1636); Return on Investment (ROI) Initiative for Unleashing American Innovation; 85 Fed. Reg. 76180; Suitability petitions; Securing America's Vaccines for Emergencies (SAVE) Act of 2020 (H.R. 6399/S. 3715); Pandemic Emergency Manufacturing Act of 2021 (S. 187); H.R.153 - Protecting Consumer Access to Generic Drugs Act of 2021; Lower Costs, More Cures Act (H.R. 19/ S. 3129); Fairness in Orphan Drug Exclusivity Act (S. 250/ H.R. 4712); S. 415 - A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity; S.164 - Advancing Education on Biosimilars Act of 2021; Preserve Access to Affordable Generics and Biosimilars Act (S. 64/HR 2375); Drug recalls; drug shortages; Elijah E. Cummings Lower Drug Costs Now Act (H.R. 3); Medicare reimbursement of prescription drugs; Unnamed bill regarding FDA demand reporting with respect to drugs.
Client expense: Not reported · Firm income: $380,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)
2020 · second_quarter · Health Issues
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
2020 · second_quarter · Health Issues
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
2020 · fourth_quarter · Health Issues
DEA implementation of the SECURE Act and specifically Section 3204 addressing specialty pharmacy delivery providerS of long-acting injectable buprenorphine products. Fairness in Orphan Drug Exclusivity Act, H.R. 4712/S. 3271, included in H.R. 133, Consolidated Appropriations Act of 2021, PL 116-196).
Client expense: Not reported · Firm income: $40,000
Government targets: Drug Enforcement Administration (DEA), HOUSE OF REPRESENTATIVES, Justice, Dept of (DOJ), SENATE
2020 · fourth_quarter · Pharmacy
H.R. 1781, Payment Commission Data Act; H.R. 1503, Orange Book Transparency Act of 2019; H.R. 1520, Purple Book Continuity Act of 2019; H.R. 965 and S. 340, the CREATES Act; H.R. 2113, Prescription Drug STAR Act of 2019; H.R. 2069/S. 474, Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2019; H.R. 2296/S. 1391, FAIR Drug Pricing Act of 2019; S. 1895, Lower Health Care Costs Act of 2019; H.R. 2296, More Efficient Tools to Realize Information for Consumers (METRIC) Act of 2019; H.R. 987, Strengthening Health Care and Lowering Prescription Drug Costs Act; H.R. 4712, Fairness in Orphan Drug Exclusivity Act.
Client expense: Not reported · Firm income: $60,000
Ordered to be Reported (Amended) by Voice Vote.
Committee Consideration and Mark-up Session Held.
Forwarded by Subcommittee to Full Committee (Amended) by Voice Vote .
Subcommittee Consideration and Mark-up Session Held.
Referred to the Subcommittee on Health.
Referred to the House Committee on Energy and Commerce.
Introduced in House
Congress.gov source codes: 1000, Intro-H
| House |
| Referred to |
| October 17, 2019 |
| October 17, 2019 |
| Republican |
| GA |
| Marc A. Veasey | Democratic | TX |
| Paul Tonko | Democratic | NY |
| Van Taylor | Republican | TX |
Client expense: $3,320,000 · Firm income: Not reported
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
Client expense: $3,320,000 · Firm income: Not reported
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
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2020 · fourth_quarter · Health Issues
Rare disease patient care, screening, and coverage issues in authorization and appropriations legislation; Orphan Drug Act; HRes 242, Affirming importance of Orphan Drug Act; Newborn Screening legislation in general; Newborn Screening Saves Lives Reauthorization Act of 2019, H.R. 2507; Lower Health Care Costs Act, S. 1895; H.R. 4144, Ending the Diagnostic Odyssey Act of 2019; H.R. 534, Aidan's Law (newborn screening for ALD); H.R. 5062, Advancing Access to Precision Medicine Act; Kidney disease diagnosis, prevention, and care; H.R. 4712, Fairness in Orphan Drug Exclusivity Act; Coronavirus Aid, Relief, and Economic Security (CARES) Act - issues concerning rare disease patients; Executive Order regarding Advancing American Kidney Health; issues concerning diagnosis, treatment, patient care for rare kidney disease; support of telehealth policies for rare disease patients; H.R. 133, Consolidated Appropriations Act of 2021.
Client expense: Not reported · Firm income: $60,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2020 · fourth_quarter · Copyright/Patent/Trademark
H.R. 938: BLOCKING Act of 2019 - Provisions related to 180 day generic prescription drug exclusivity H.R. 1503: Orange Book Transparency Act - Provisions related to prescription drug and device patent listings H.R. 1520: Purple Book Continuity Act of 2019 - Provisions related to biologic patent listings H.R. 3666: STRONGER Patents Act of 2019 - Provisions related to patents H.R. 3991: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 - Provisions related to patent litigation H.R. 4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 - Provisions related to prescription drug patents H.R. 4712: Fairness in Orphan Drug Exclusivity Act - Provisions related to prescription drug exclusivity periods H.R. 4850: Biologic Patent Transparency Act - Provisions related to prescription drug patent disclosures H.R. 5133: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 - Provisions related to prescription drug exclusivity periods and manufacturer behavior S. 64: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 102: Prescription Drug Price Relief Act of 2019 - Provisions related to foreign reference pricing, patents and march-in rights S. 659: Biologic Patent Transparency Act - Provisions related to biologic patent disclosures S. 1416: Affordable Prescriptions for Patients Act of 2019 - Provisions related to prescription drug patents S. 1636: Ensuring Innovation Act - Provisions related to new chemical entity exclusivity Biopharmaceutical innovation and patent policy issues Patent litigation reform issues and issues related to post-grant proceeding at the PTO Bayh-Dole march-in rights policy issues
Client expense: $5,130,000 · Firm income: Not reported
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), Homeland Security, Dept of (DHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE
2020 · fourth_quarter · Copyright/Patent/Trademark
H.R. 938: BLOCKING Act of 2019 - Provisions related to 180 day generic prescription drug exclusivity H.R. 1503: Orange Book Transparency Act - Provisions related to prescription drug and device patent listings H.R. 1520: Purple Book Continuity Act of 2019 - Provisions related to biologic patent listings H.R. 3666: STRONGER Patents Act of 2019 - Provisions related to patents H.R. 3991: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 - Provisions related to patent litigation H.R. 4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 - Provisions related to prescription drug patents H.R. 4712: Fairness in Orphan Drug Exclusivity Act - Provisions related to prescription drug exclusivity periods H.R. 4850: Biologic Patent Transparency Act - Provisions related to prescription drug patent disclosures H.R. 5133: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 - Provisions related to prescription drug exclusivity periods and manufacturer behavior S. 64: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 102: Prescription Drug Price Relief Act of 2019 - Provisions related to foreign reference pricing, patents and march-in rights S. 659: Biologic Patent Transparency Act - Provisions related to biologic patent disclosures S. 1416: Affordable Prescriptions for Patients Act of 2019 - Provisions related to prescription drug patents S. 1636: Ensuring Innovation Act - Provisions related to new chemical entity exclusivity Biopharmaceutical innovation and patent policy issues Patent litigation reform issues and issues related to post-grant proceeding at the PTO Bayh-Dole march-in rights policy issues
Client expense: $750,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)
Biopharmaceutical Intellectual Property Data exclusivity Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO BPCIA Patents Inter Partes Review at PTO Biosimilars S 1416 - Affordable Prescriptions for Patients Act of 2019 H.R.465 - Prescription Drug Price Relief Act of 2019 H.R.938 - BLOCKING Act of 2019 H.R.987 - Strengthening Health Care and Lowering Prescription Drug Costs Act H.R.1046 - Medicare Negotiation and Competitive Licensing Act of 2019 Bayh-Dole Act Section 101 H.R.3991 - Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 H.R.4398 - Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 S.1617 - Second Look at Drug Patents Act of 2019 HR 4712 - Fairness in Orphan Drug Exclusivity Act HR 4850 - Biologic Patent Transparency Act - Provisions related to prescription drug patent disclosures HR 5133 - Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 Intellectual Property Issues in Response to coronavirus S.2387 - We Protect American Investment in Drugs Act of 2019 S.64 - Preserve Access to Affordable Generics & Biosimilars Act of 2019
Client expense: $660,000 · Firm income: Not reported
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), Veterans Affairs, Dept of (VA), White House Office
2020 · fourth_quarter · Health Issues
Rare disease patient care, screening, and coverage issues in authorization and appropriations legislation; Orphan Drug Act; H.R. 2507, S. 2158 Newborn Screening Saves Lives Act Reauthorization; FY 2021 CDC Appropriations; HR 4144, Ending the Diagnostic Odyssey Act; H.R. 5062, Advancing Access to Precision Medicine Act; H.R. 4712, S. 3271 Fairness in Orphan Drug Exclusivity Act; H.R. 534, Aidan's Law; HR 6238, Cameron's Law; rare kidney disease issues; HR 133, Consolidated Appropriations Act of 2021
Client expense: $150,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2020 · fourth_quarter · Health Issues
21st Century Cures Act 2.0 ---RFI from House Energy and Commerce Committee 340B Drug Discount Program ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Nonfunding) ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Families First Coronavirus Response Act of 2020 Biosimilars ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---Biosimilar Copay ---Reimbursement Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.7661: Coronavirus Emerging Growth Companies (EGC) Extension Act of 2020 ---H.R.8080: Health STATISTICS Act of 2020 ---S.4317: SAFE TO WORK Act ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Drug Supply Chain Management ---Immunization information systems ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Families First Coronavirus Response Act of 2020 ---In-Home Administration of Part B Drugs ---Operation Warp Speed ---Patient Cost-Sharing and Smoothing ---PREP Act COVID-19 declaration coverage for private sector procurement ---Preventive Monoclonal Antibody Coverage Diversity & Inclusion Drug Evaluation and Review ---COVID-19 Lessons Learned ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs Drug Importation ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---General Drug Manufacturing, Quality & Distribution ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.7767: To amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment ---Drug Shortages ---Executive Order on Buy American Drug Patenting ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.3991: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 ---S.1617: Second Look at Drug Patents Act of 2019 Drug Pricing ---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.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1425: The Patient Protection and Affordable Care Enhancement Act of 2020 ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.3991: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 ---S.1617: Second Look at Drug Patents Act of 2019 ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Executive Order on Lowering Drug Prices by Putting America First (Most Favored Nation, or MFN, EO) ---General ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---International Pricing Index Proposal ---Most Favored Nation (MFN) Model interim final rule (MFN Rule) Funding for Antimicrobial Resistance Programs ---H.J.Res.107: Further Additional Continuing Appropriations Act of FY 2021 ---H.J.Res.110: Extension of Continuing Appropriations Act of FY 2021 ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1520: Further Extension of Continuing Appropriations Act of FY 2021 ---H.R.8337: The Continuing Appropriations Act for FY 2021 and Other Extensions Act ---H.R.8900: Further Continuing Appropriations Act for FY 2021, and Other Extensions Act ---S.4760:Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.J.Res.107: Further Additional Continuing Appropriations Act of FY 2021 ---H.J.Res.110: Extension of Continuing Appropriations Act of FY 2021 ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1520: Further Extension of Continuing Appropriations Act of FY 2021 ---H.R.8337: The Continuing Appropriations Act for FY 2021 and Other Extensions Act ---H.R.8900: Further Continuing Appropriations Act for FY 2021, and Other Extensions Act ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for FDA ---H.J.Res.107: Further Additional Continuing Appropriations Act of FY 2021 ---H.J.Res.110: Extension of Continuing Appropriations Act of FY 2021 ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1520: Further Extension of Continuing Appropriations Act of FY 2021 ---H.R.8337: The Continuing Appropriations Act for FY 2021 and Other Extensions Act ---H.R.8900: Further Continuing Appropriations Act for FY 2021, and Other Extensions Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Health Resources and Services Administration (HRSA) - Countermeasures Injury Compensation Program (CICP) ---H.J.Res.107: Further Additional Continuing Appropriations Act of FY 2021 ---H.J.Res.110: Extension of Continuing Appropriations Act of FY 2021 ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1520: Further Extension of Continuing Appropriations Act of FY 2021 ---H.R.8337: The Continuing Appropriations Act for FY 2021 and Other Extensions Act ---H.R.8900: Further Continuing Appropriations Act for FY 2021, and Other Extensions Act Funding for National Institutes of Health ---H.J.Res.107: Further Additional Continuing Appropriations Act of FY 2021 ---H.J.Res.110: Extension of Continuing Appropriations Act of FY 2021 ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1520: Further Extension of Continuing Appropriations Act of FY 2021 ---H.R.8337: The Continuing Appropriations Act for FY 2021 and Other Extensions Act ---H.R.8900: Further Continuing Appropriations Act for FY 2021, and Other Extensions Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.J.Res.107: Further Additional Continuing Appropriations Act of FY 2021 ---H.J.Res.110: Extension of Continuing Appropriations Act of FY 2021 ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1520: Further Extension of Continuing Appropriations Act of FY 2021 ---H.R.8337: The Continuing Appropriations Act for FY 2021 and Other Extensions Act ---H.R.8900: Further Continuing Appropriations Act for FY 2021, and Other Extensions Act ---Funding for 2020-21 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---H.J.Res.107: Further Additional Continuing Appropriations Act of FY 2021 ---H.J.Res.110: Extension of Continuing Appropriations Act of FY 2021 ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1520: Further Extension of Continuing Appropriations Act of FY 2021 ---H.R.8337: The Continuing Appropriations Act for FY 2021 and Other Extensions Act ---H.R.8900: Further Continuing Appropriations Act for FY 2021, and Other Extensions Act Medicaid ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 ---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 Orphan Drug Issues ---H.J.Res.107: Further Additional Continuing Appropriations Act of FY 2021 ---H.J.Res.110: Extension of Continuing Appropriations Act of FY 2021 ---H.R.1520: Further Extension of Continuing Appropriations Act of FY 2021 ---H.R.4439/S.4010: Creating Hope Reauthorization Act of 2019 ---H.R.4712: Fairness in Orphan Drug Exclusivity Act of 2019 ---H.R.8337: The Continuing Appropriations Act for FY 2021 and Other Extensions Act ---H.R.8900: Further Continuing Appropriations Act for FY 2021, and Other Extensions Act Rare Pediatric Disease Priority Review ---H.J.Res.107: Further Additional Continuing Appropriations Act of FY 2021 ---H.J.Res.110: Extension of Continuing Appropriations Act of FY 2021 ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.1520: Further Extension of Continuing Appropriations Act of FY 2021 ---H.R.4439/S.4010: Creating Hope Reauthorization Act of 2019 ---H.R.8337: The Continuing Appropriations Act for FY 2021 and Other Extensions Act ---H.R.8900: Further Continuing Appropriations Act for FY 2021, and Other Extensions Act Reimbursement and Coverage of Innovative Products ---H.R.3: Lower Drug Costs Now Act of 2019 ---H.J.Res.107: Further Additional Continuing Appropriations Act of FY 2021 ---H.J.Res.110: Extension of Continuing Appropriations Act of FY 2021 ---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.1520: Further Extension of Continuing Appropriations Act of FY 2021 ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 ---H.R.8337: The Continuing Appropriations Act for FY 2021 and Other Extensions Act ---H.R.8900: Further Continuing Appropriations Act for FY 2021, and Other Extensions Act ---S.2326: New Opportunities for Value that Extend Lives (NOVEL) Act of 2019 ---Administration Rebate Rule ---CMMI Authority ---Executive Order on Increasing Drug Importation to Lower Prices for American Patients ---Executive Order on Lowering Drug Prices by Putting America First (Most Favored Nation, MFN EO) ---In-Home Administration of Part B Drugs ---International Pricing Index Proposal ---Medicare Part B Physician-Administered Products ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-Based Contracting and Communications ---Value-Based Purchasing (VBP) Rule The United States-Mexico-Canada Agreement (USMCA) ---Implementation of United States-Mexico-Canada Agreement (USMCA) ---IP Provisions US-China Trade Agreement ---IP Provisions US-UK Trade Agreement ---IP Provisions Vaccine Injury Compensation Program Tax ---H.R.1973/S.1654: Vaccine Access Improvement Act of 2019 Vaccines and Infectious Diseases ---H.R.133: Consolidated Appropriations Act for FY 2021 ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019 ---S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 ---Adult Immunization Education ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Families First Coronavirus Response Act of 2020 ---Maternal Immunization ---Operation Warp Speed ---Preventive Monoclonal Antibody Coverage ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety
Client expense: $3,180,000 · Firm income: Not reported
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), Health Resources & Services Administration (HRSA), Natl Economic Council (NEC), Natl Institute of Standards & Technology (NIST), Natl Institutes of Health (NIH), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office
2020 · fourth_quarter · Health Issues
Issues related to Drug Enforcement Agency (DEC) implementation of S. 916; Reimbursement issues; issues related to opioid addiction; issues related to NIH/HHS funding levels; issues related to funding for CARA, medication assisted treatment and 21st Century Cures Act; Implementation of CARA Act. S. 2543, Prescription Drug Pricing Reduction Act (PDPRA) of 2019 and H.R. 3, Lower Drug Costs Now Act of 2019. H.R. 4712 Fairness in Orphan Drug Exclusivity Act. Policies impacting U.S. address to the Covid-19 pandemic, including H.R. 604 Coronavirus Preparedness and Response Supplemental Appropriations Act, Public Law No: 116-123.; H. R . 6201 Families First Coronavirus Response Act, Public Law No: 116-127; and H. R. 748 CARES Act, Public Law No: 116-136. Policies impacting orphan drug approval and reimbursement, including H.R. 4712/S. 3272, Fairness in Orphan Drug Exclusivity Act; and H.R. 133, Consolidated Appropriations Act, 2021, Public Law No: 116-260.
Client expense: Not reported · Firm income: $60,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
2020 · fourth_quarter · Health Issues
Expand access to treatment for persons with opioid use disorder. HR 4712 / S 3271, Fairness in Orphan Drug Exclusivity Act. HR 1329, the Medicaid Reentry Act. HR 1865 / HR 2740, FY21 Labor-HHS-Education Appropriations Act. HR 3055, FY21 Commerce-Justice-Science Appropriations Act. HR 4378 / HR 3055, FY21 Continuing Resolution Appropriations Act. HR 133 Omnibus FY21 Appropriations and COVID Relief
Client expense: Not reported · Firm income: $20,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2020 · fourth_quarter · Health Issues
HR 4712, S3271 Fairness in Orphan Drug Exclusivity Act; Administration of controlled substances by HCPs; Storage of controlled substances
Client expense: $100,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · fourth_quarter · Pharmacy
HR 4712, S3271 Fairness in Orphan Drug Exclusivity Act; Administration of controlled substances by HCPs; Storage of controlled substances
Client expense: $100,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · fourth_quarter · Insurance
HR 4712, S3271 Fairness in Orphan Drug Exclusivity Act; Administration of controlled substances by HCPs; Storage of controlled substances
Client expense: $100,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · fourth_quarter · Alcohol and Drug Abuse
HR 4712, S3271 Fairness in Orphan Drug Exclusivity Act; Administration of controlled substances by HCPs; Storage of controlled substances
Client expense: $100,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · fourth_quarter · Medicare/Medicaid
HR 4712, S3271 Fairness in Orphan Drug Exclusivity Act; Administration of controlled substances by HCPs; Storage of controlled substances
Client expense: $100,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · fourth_quarter · Health Issues
reducing stigma and promoting treatment of opioid use disorder raising awareness of the benefits of medication assisted therapy (MAT) ensuring patient access to MAT FDA approval and exclusivity process HR 4712 Fairness in Orphan Drug Exclusivity Act S 3271 Fairness in Orphan Drug Exclusivity Act patient access to practitioner-administered therapies
Client expense: Not reported · Firm income: $50,000
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Natl Drug Control Policy (NDCP), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), White House Office
2020 · third_quarter · Health Issues
DEA implementation of the SECURE Act and specifically Section 3204 addressing specialty pharmacy delivery to the provider of long-acting injectable buprenorphine products. Fairness in Orphan Drug Exclusivity Act, H.R. 4712/S. 3271.
Client expense: Not reported · Firm income: $40,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · third_quarter · Health Issues
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
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
2020 · third_quarter · Pharmacy
H.R. 1781, Payment Commission Data Act; H.R. 1503, Orange Book Transparency Act of 2019; H.R. 1520, Purple Book Continuity Act of 2019; H.R. 965 and S. 340, the CREATES Act; H.R. 2113, Prescription Drug STAR Act of 2019; H.R. 2069/S. 474, Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2019; H.R. 2296/S. 1391, FAIR Drug Pricing Act of 2019; S. 1895, Lower Health Care Costs Act of 2019; H.R. 2296, More Efficient Tools to Realize Information for Consumers (METRIC) Act of 2019; H.R. 987, Strengthening Health Care and Lowering Prescription Drug Costs Act; H.R. 4712, Fairness in Orphan Drug Exclusivity Act.
Client expense: Not reported · Firm income: $60,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2020 · third_quarter · Health Issues
Rare disease patient care, screening, and coverage issues in authorization and appropriations legislation; Orphan Drug Act; HRes 242, Affirming importance of Orphan Drug Act; Newborn Screening legislation in general; Newborn Screening Saves Lives Reauthorization Act of 2019, H.R. 2507; Lower Health Care Costs Act, S. 1895; H.R. 4144, Ending the Diagnostic Odyssey Act of 2019; H.R. 534, Aidan's Law (newborn screening for ALD); H.R. 5062, Advancing Access to Precision Medicine Act; Kidney disease diagnosis, prevention, and care; H.R. 4712, Fairness in Orphan Drug Exclusivity Act; Coronavirus Aid, Relief, and Economic Security (CARES) Act - issues concerning rare disease patients; Executive Order regarding Advancing American Kidney Health; issues concerning diagnosis, treatment, patient care for rare kidney disease; support of telehealth policies for rare disease patients.
Client expense: Not reported · Firm income: $60,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2020 · third_quarter · Health Issues
Rare disease patient care, screening, and coverage issues in authorization and appropriations legislation; Orphan Drug Act; H.R. 2507, S. 2158 Newborn Screening Saves Lives Act Reauthorization; FY 2021 CDC Appropriations; HR 4144, Ending the Diagnostic Odyssey Act; H.R. 5062, Advancing Access to Precision Medicine Act; H.R. 4712, S. 3271 Fairness in Orphan Drug Exclusivity Act; H.R. 534, Aidan's Law; HR 6238, Cameron's Law; rare kidney disease issues
Client expense: $170,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2020 · third_quarter · Health Issues
H.R. 2507: NEWBORN SCREENING SAVES LIVES REAUTHORIZATION ACT OF 2019; ALL PROVISIONS OF THE BILL H.R. 4439: CREATING HOPE REAUTHORIZATION ACT; ALL PROVISIONS OF THE BILL H.R. 4712: FAIRNESS IN ORPHAN DRUG EXCLUSIVITY ACT; ALL PROVISIONS OF THE BILL H.R. 7567: HELPING EXPERTS ACCELERATE RARE TREATMENTS (HEARTS) ACT OF 2020; ALL PROVISIONS OF THE BILL H.R. 7647: TO PROVIDE FOR A COVID-19-RELATED DELAY REGARDING ANNUAL LIMITATION ON COST-SHARING FOR GROUP HEALTH PLANS AND INDIVIDUAL AND SMALL GROUP HEALTH INSURANCE COVERAGE; ALL PROVISIONS OF THE BILL S. 2158: NEWBORN SCREENING SAVES LIVES REAUTHORIZATION ACT OF 2019; ALL PROVISIONS OF THE BILL S. 4010: CREATING HOPE REAUTHORIZATION ACT; ALL PROVISIONS OF THE BILL GENERAL DISCUSSIONS REGARDING FOOD & DRUG ADMINISTRATION'S COMPLETE RESPONSE LETTER; BREAKTHROUGH THERAPY PROGRAM; HEALTH INNOVATION; NEWBORN SCREENING; VALUE BASED ARRANGEMENTS
Client expense: $230,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2020 · third_quarter · Taxation/Internal Revenue Code
Issues related to the Orphan Drug Tax Credit and corporate tax reform implementation (no specific bills). Issues related to coronavirus pandemic response (HR 748: "Coronavirus Aid, Relief, and Economic Security Act" and HR 4712: "Fairness in Orphan Drug Exclusivity Act.").
Client expense: $380,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
Biopharmaceutical Intellectual Property Data exclusivity Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO BPCIA Patents Inter Partes Review at PTO Biosimilars S 1416 - Affordable Prescriptions for Patients Act of 2019 H.R.465 - Prescription Drug Price Relief Act of 2019 H.R.938 - BLOCKING Act of 2019 H.R.987 - Strengthening Health Care and Lowering Prescription Drug Costs Act H.R.1046 - Medicare Negotiation and Competitive Licensing Act of 2019 Bayh-Dole Act Section 101 H.R.3991 - Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 H.R.4398 - Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 S.1617 - Second Look at Drug Patents Act of 2019 HR 4712 - Fairness in Orphan Drug Exclusivity Act HR 4850 - Biologic Patent Transparency Act - Provisions related to prescription drug patent disclosures HR 5133 - Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 Intellectual Property Issues in Response to coronavirus S.2387 - We Protect American Investment in Drugs Act of 2019 S.64 - Preserve Access to Affordable Generics & Biosimilars Act of 2019
Client expense: $1,190,000 · Firm income: Not reported
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
2020 · third_quarter · Pharmacy
HR 4712, S3271 Fairness in Orphan Drug Exclusivity Act; Administration of controlled substances by HCPs; Storage of controlled substances
Client expense: $120,000 · Firm income: Not reported
Government targets: Drug Enforcement Administration (DEA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), SENATE
2020 · third_quarter · Insurance
HR 4712, S3271 Fairness in Orphan Drug Exclusivity Act; Administration of controlled substances by HCPs; Storage of controlled substances
Client expense: $120,000 · Firm income: Not reported
Government targets: Drug Enforcement Administration (DEA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), SENATE
2020 · third_quarter · Health Issues
HR 4712, S3271 Fairness in Orphan Drug Exclusivity Act; Administration of controlled substances by HCPs; Storage of controlled substances
Client expense: $120,000 · Firm income: Not reported
Government targets: Drug Enforcement Administration (DEA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), SENATE
2020 · third_quarter · Medicare/Medicaid
HR 4712, S3271 Fairness in Orphan Drug Exclusivity Act; Administration of controlled substances by HCPs; Storage of controlled substances
Client expense: $120,000 · Firm income: Not reported
Government targets: Drug Enforcement Administration (DEA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), SENATE
2020 · third_quarter · Alcohol and Drug Abuse
HR 4712, S3271 Fairness in Orphan Drug Exclusivity Act; Administration of controlled substances by HCPs; Storage of controlled substances
Client expense: $120,000 · Firm income: Not reported
Government targets: Drug Enforcement Administration (DEA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), SENATE
2020 · third_quarter · Health Issues
Issues related to Drug Enforcement Agency (DEC) implementation of S. 916; Reimbursement issues; issues related to opioid addiction; issues related to NIH/HHS funding levels; issues related to funding for CARA, medication assisted treatment and 21st Century Cures Act; Implementation of CARA Act. S. 2543, Prescription Drug Pricing Reduction Act (PDPRA) of 2019 and H.R. 3, Lower Drug Costs Now Act of 2019. H.R. 4712 Fairness in Orphan Drug Exclusivity Act. Policies impacting U.S. address to the Covid-19 pandemic, including H.R. 604 Coronavirus Preparedness and Response Supplemental Appropriations Act, Public Law No: 116-123.; H. R . 6201 Families First Coronavirus Response Act, Public Law No: 116-127; and H. R. 748 CARES Act, Public Law No: 116-136. Policies impacting orphan drug approval and reimbursement, including H.R. 4712/S. 3272, Fairness in Orphan Drug Exclusivity Act.
Client expense: Not reported · Firm income: $60,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
2020 · third_quarter · Health Issues
Expand access to treatment for persons with opioid use disorder. HR 4712 / S 3271, Fairness in Orphan Drug Exclusivity Act. HR 1329, the Medicaid Reentry Act. HR 6800 /HR 925 as amended, HEROES Act. HR 1865 / HR 2740, FY21 Labor-HHS-Education Appropriations Act, HR 3055, FY21 Commerce-Justice-Science Appropriations Act. HR 4378 / HR 3055, FY21 Continuing Resolution Appropriations Act.
Client expense: Not reported · Firm income: $20,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2020 · third_quarter · Health Issues
reducing stigma and promoting treatment of opioid use disorder raising awareness of the benefits of medication assisted therapy (MAT) ensuring patient access to MAT FDA approval and exclusivity process HR 4712 Fairness in Orphan Drug Exclusivity Act S 3271 Fairness in Orphan Drug Exclusivity Act patient access to practitioner-administered therapies
Client expense: Not reported · Firm income: $50,000
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Natl Drug Control Policy (NDCP), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), White House Office
2020 · second_quarter · Health Issues
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
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
2020 · second_quarter · Health Issues
HR 4712, S3271 Fairness in Orphan Drug Exclusivity Act: General lobbying pertaining to opioid crisis; controlled substances and specialty pharmacies
Client expense: $100,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Office of Natl Drug Control Policy (NDCP), SENATE
2020 · second_quarter · Alcohol and Drug Abuse
HR 4712, S3271 Fairness in Orphan Drug Exclusivity Act: General lobbying pertaining to opioid crisis; controlled substances and specialty pharmacies
Client expense: $100,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Office of Natl Drug Control Policy (NDCP), SENATE
2020 · second_quarter · Pharmacy
HR 4712, S3271 Fairness in Orphan Drug Exclusivity Act: General lobbying pertaining to opioid crisis; controlled substances and specialty pharmacies
Client expense: $100,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Office of Natl Drug Control Policy (NDCP), SENATE
2020 · second_quarter · Insurance
HR 4712, S3271 Fairness in Orphan Drug Exclusivity Act: General lobbying pertaining to opioid crisis; controlled substances and specialty pharmacies
Client expense: $100,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Office of Natl Drug Control Policy (NDCP), SENATE
2020 · second_quarter · Medicare/Medicaid
HR 4712, S3271 Fairness in Orphan Drug Exclusivity Act: General lobbying pertaining to opioid crisis; controlled substances and specialty pharmacies
Client expense: $100,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Office of Natl Drug Control Policy (NDCP), SENATE
2020 · second_quarter · Health Issues
Rare disease patient care, screening, and coverage issues in authorization and appropriations legislation; Orphan Drug Act; HRes 242, Affirming importance of Orphan Drug Act; Newborn Screening legislation in general; Newborn Screening Saves Lives Reauthorization Act of 2019, H.R. 2507; Lower Health Care Costs Act, S. 1895; H.R. 4144, Ending the Diagnostic Odyssey Act of 2019; H.R. 534, Aidan's Law (newborn screening for ALD); H.R. 5062, Advancing Access to Precision Medicine Act; Kidney disease diagnosis, prevention, and care; H.R. 4712, Fairness in Orphan Drug Exclusivity Act; Coronavirus Aid, Relief, and Economic Security (CARES) Act - issues concerning rare disease patients; Executive Order regarding Advancing American Kidney Health; issues concerning diagnosis, treatment, patient care, for rare kidney disease.
Client expense: Not reported · Firm income: $60,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2020 · second_quarter · Pharmacy
H.R. 1781, Payment Commission Data Act; H.R. 1503, Orange Book Transparency Act of 2019; H.R. 1520, Purple Book Continuity Act of 2019; H.R. 965 and S. 340, the CREATES Act; H.R. 2113, Prescription Drug STAR Act of 2019; H.R. 2069/S. 474, Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2019; H.R. 2296/S. 1391, FAIR Drug Pricing Act of 2019; S. 1895, Lower Health Care Costs Act of 2019; H.R. 2296, More Efficient Tools to Realize Information for Consumers (METRIC) Act of 2019; H.R. 987, Strengthening Health Care and Lowering Prescription Drug Costs Act; H.R. 4712, Fairness in Orphan Drug Exclusivity Act.
Client expense: Not reported · Firm income: $60,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
Biopharmaceutical Intellectual Property Data exclusivity Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO BPCIA Patents Inter Partes Review at PTO Biosimilars S 1416 - Affordable Prescriptions for Patients Act of 2019 H.R.465 - Prescription Drug Price Relief Act of 2019 H.R.938 - BLOCKING Act of 2019 H.R.987 - Strengthening Health Care and Lowering Prescription Drug Costs Act H.R.1046 - Medicare Negotiation and Competitive Licensing Act of 2019 Bayh-Dole Act Section 101 H.R.3991 - Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 H.R.4398 - Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 S.1617 - Second Look at Drug Patents Act of 2019 HR 4712 - Fairness in Orphan Drug Exclusivity Act H.R. 4850: Biologic Patent Transparency Act - Provisions related to prescription drug patent disclosures H.R. 5133: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 - Provisions related to prescription drug exclusivity periods and manufacturer behavior Intellectual Property Issues in Response to coronavirus S. 2387, We Protect American Investment in Drugs Act of 2019 S. 64, Preserve Access to Affordable Generics & Biosimilars Act of 2019
Client expense: $780,000 · Firm income: Not reported
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
2020 · second_quarter · Taxation/Internal Revenue Code
Issues related to the Orphan Drug Tax Credit and corporate tax reform implementation (no specific bills). Issues related to coronavirus pandemic response (HR 748: "Coronavirus Aid, Relief, and Economic Security Act" and HR 4712: "Fairness in Orphan Drug Exclusivity Act.").
Client expense: $380,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2020 · second_quarter · Health Issues
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; H.R. 1425, The Patient Protection and Affordable Care Enhancement Act Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; S. 205, The Right Rebate Act of 2019 -provisions related to Medicaid drug rebates and drug classification; The Patient Affordability, Value and Efficiency Act (not yet introduced); H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; Discussions related to co-pay accumulators; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; Discussions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2375, S. 64, Preserve Access to Affordable Generics and Biosimilars Act - provisions related to patent settlements; H.R. 937, Right Rebate Act of 2019 - provisions related to Medicaid drug rebates and drug classification; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; H.R. 19, Lower Costs, More Cures Act of 2019 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 3165, Mental Health Parity Compliance Act - provisions related to mental health coverage; H.R. 5201, Telemental Health Expansion Act of 2019 - provisions related to mental telehealth coverage; H.R. 5469, Pursuing Equity in Mental Health Act of 2019 - provisions related to mental health coverage; Issues related to global pharmaceutical supply chain operations and manufacturing locations; H.R. 4712, Fairness in Orphan Drug Exclusivity Act - provisions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heros Act - provisions related to tax issues and plasma treatments;
Client expense: $1,330,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE
2020 · second_quarter · Health Issues
Expand access to treatment for persons with opioid use disorder. HR 4712 / S 3271, Fairness in Orphan Drug Exclusivity Act. HR 1329, the Medicaid Reentry Act. FY21 Labor-HHS-Education Appropriations Act, FY21 Commerce-Justice-Science Appropriations Act.
Client expense: Not reported · Firm income: $10,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2020 · second_quarter · Health Issues
DEA implementation of the SECURE Act and specifically Section 3204 addressing specialty pharmacy delivery to the provider of long-acting injectable buprenorphine products. Fairness in Orphan Drug Exclusivity Act, H.R. 4712/S. 3271.
Client expense: Not reported · Firm income: $40,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · second_quarter · Health Issues
reducing stigma and promoting treatment of opioid use disorder raising awareness of the benefits of medication assisted therapy (MAT) ensuring patient access to MAT FDA approval and exclusivity process HR 4712 Fairness in Orphan Drug Exclusivity Act S 3271 Fairness in Orphan Drug Exclusivity Act patient access to practitioner-administered therapies
Client expense: Not reported · Firm income: $50,000
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Natl Drug Control Policy (NDCP), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), White House Office
2020 · second_quarter · Pharmacy
Opioids; CREATES Act; Drug Pricing HR 4712 (116th Congress), Fairness in Orphan Drug Exclusivity Act, by Rep. Madeleine Dean (D-PA). Amend the Federal Food, Drug, and Cosmetic Act with respect to limitations on exclusive approval or licensure of orphan drugs. HR 5578 (116th Congress), Recall Unsafe Drugs Act of 2020, by Rep. Rosa DeLauro (D-CT). Provide for the mandatory recall of drugs regulated by the Food and Drug Administration. HR 5663 (116th Congress), Safeguarding Therapeutics Act, by Rep. Brett Guthrie (R-KY). Give authority to the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to destroy counterfeit devices. HR 5691 (116th Congress), Insulin Affordability Data Collection Act, by Rep. Angie Craig (D-MN). Require the Secretary to conduct a study and issue a report on the affordability of insulin. HR 5749 (116th Congress), Affordable Insulin for All Act, by Rep. Charlie Crist (D-FL). Establish the American Insulin Program to provide for lower prices for insulin drugs, to maintain effort throughout the insulin supply chain. HR 5894 (116th Congress), Transparency in Prescription Drug Advertising Act, by Rep. Sharice Davids (D-KS). Directs the Secretary of Health and Human Services to issue guidance requiring the list prices of drugs to be included in advertisements for such drugs. HR 5927 (116th Congress), Safe Medicine Act, by Rep. Bill Posey (R-FL). Directs the Secretary of Health and Human Services to study American dependence on unsafe Chinese pharmaceuticals and to empower the Food and Drug Administration to mandate drug recalls in the case of critical contamination. HR 5982 (116th Congress), Safe Medicine Act, by Rep. Bill Posey (R-FL). Directs the Secretary of Health and Human Services to study American dependence on Chinese pharmaceuticals and to empower the Food and Drug Administration to issue boxed warnings in the case of critical contamination. HR 6193 (116th Congress), Medication Access in Emergencies Act of 2020, by Rep. Chris Pappas (D-NH). Require group health plans and health insurance issuers offering group or individual health insurance coverage to provide benefits under such plan or such coverage for a 30-day refill of prescription drugs to individuals who reside in emergency areas during emergency periods. HR 6731 (116th Congress), Securing Americas Pharmaceutical Supply Chain Act, by Rep. Pete Stauber (R-MN). Require executive agencies to purchase pharmaceuticals from the United States.
Client expense: $350,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, White House Office