National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2020

H.R. 36: Combating Sexual Harassment in Science Act of 2019 To provide for research to better understand the causes and consequences of sexual harassment affecting individuals in the scientific, technical, engineering, and mathematics workforce and to examine policies to reduce the prevalence and negative impact of such harassment, and for other purposes (ALL). H.R. 539 and S. 118: Innovators to Entrepreneurs Act of 2019 To require the Director of the National Science Foundation to develop an I-Corps course to support commercialization-ready innovation companies, and for other purposes (ALL). S. 937: Protecting American Technologies Act of 2019 A bill to direct the Secretary of Commerce to require institutions of higher education and other research facilities to obtain deemed export licenses for foreign nationals conducting scientific research at such institutions and facilities, and for other purposes (ALL). S. 2133: Secure American Research Act of 2019 A bill to establish an interagency working group for coordination and development of Federal research protection, and for other purposes (ALL). H.R. 4091 and S. 2714: ARPA-E Reauthorization Act of 2019 To amend the America COMPETES Act to reauthorize the ARPA-E program, and for other purposes (ALL). H.R. 3666 and S. 2082: Support Technology and Research for Our Nation's Growth and Economic Resilience (STRONGER) Patents Act of 2019 A bill to strengthen the position of the United States as the world's leading innovator by amending title 35, United States Code, to protect the property rights of the inventors that grow the country's economy (ALL). H.R. 4866: National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2019 To amend the 21st Century Cures Act to provide for designation of institutions of higher education that provide research, data, and leadership on continuous manufacturing as National Centers of Excellence in Continuous Pharmaceutical Manufacturing, and for other purposes (ALL). S. 3432: Securing America's Medicine Cabinet Act of 2020 A bill to support the advanced manufacturing technologies program of the Food and Drug Administration, to establish National Centers of Excellence in Advanced Pharmaceutical Manufacturing, and for other purposes (ALL). H.R. 7308 and S. 4286: Research Investment to Spark the Economy (RISE) Act To authorize appropriations for offsetting the costs related to reductions in research productivity resulting from the coronavirus pandemic (ALL). S. 3997: Safeguarding American Innovation Act A bill to strengthen the security and integrity of the United States scientific and research enterprise (ALL). S. 4629: America Labor, Economic competitiveness, Alliances, Democracy and Security (America LEADS) Act A bill to address issues involving the People's Republic of China (provisions relating to scientific research funding, foreign gift reporting, and Chinese language and culture instruction). Federal policy changes regarding fetal tissue research.

Client expense: $70,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Compounding; Lower Health Care Costs Act (S.1895); Drug Pricing; 21st Century Cures Act 2.0; CARES Act (S. 3548/H.R. 748); COVID-19 pandemic response; HEROES Act (H.R. 6800); National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act (H.R. 4866); Health, Economic Assistance, Liability Protection and Schools (HEALS) Act; FY 2021 Consolidated Appropriations Act (H.R. 133)

Client expense: Not reported · Firm income: $40,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Compounding; Lower Health Care Costs Act (S.1895); Drug Pricing; 21st Century Cures Act 2.0; CARES Act (S. 3548/H.R. 748); COVID-19 pandemic response; HEROES Act (H.R. 6800); National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act (H.R. 4866); Health, Economic Assistance, Liability Protection and Schools (HEALS) Act; FY 2021 Consolidated Appropriations Act (H.R. 133)

Client expense: Not reported · Firm income: $40,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to generic pharmaceuticals and biosimilars, including H. R. 928, the BLOCKING Act of 2019. Changes to the Risk Evaluation and Mitigation Strategies (REMS) program. Reimbursement rate for biosimilars. S. 1895, the Lower Health Care Costs Act, S.2543, The Prescription Drug Pricing Reduction Act, and H. R. 3,The Lower Drug Costs Now Act. H. R. 1865. Issues related to the implementation of H. R. 748, Coronavirus Aid, Relief, and Economic Security Act (CARES Act), including supply chain issues for generic medicines. Issues related to H.R.6395 and S.4049, National Defense Authorization Act for Fiscal Year 2021, including pharmaceutical supply chain provisions. Issues related to H.R. 4866, National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act, including domestic pharmaceutical manufacturing. Issues related to H.R. 133, Consolidated Appropriations Act for Fiscal Year 2021. Issues related to H.R. 6179, Increasing Access to Biosimilars Act of 2020, H.R. 4597, the ACCESS Act, and H.R. 4455, the Biosim Act.

Client expense: Not reported · Firm income: $60,000

H.R. 2209, To establish the position of Chief Pharmaceutical Negotiator in the Office of the United States Trade Representative responsible for conducting trade negotiations and enforcing trade agreements related to acts, policies, and practices of foreign governments that fail to appropriately reward United States innovation with respect to pharmaceuticals, and for other purposes, regarding all bio-pharmaceutical related provisions. Unite States, Mexico, Canada Trade Agreement, regarding all bio-pharmaceutical related provisions. S. 3537, Protecting our Pharmaceutical Supply Chain from China Act of 2020, regarding all bio-pharmaceutical related provisions S. 3538, Strengthening Americas Supply Chain and National Security Act, regarding all bio-pharmaceutical related provisions No Bill, potential Buy American executive order for health-related goods, regarding all bio-pharmaceutical related provisions H.R. 4710, Pharmaceutical Independence Long-Term Readiness Reform Act, regarding all bio-pharmaceutical related provisions H.R. 4866, National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2019, regarding all bio-pharmaceutical related provisions H.R. 5381, International Pharmaceutical Transparency Act of 2019 , regarding all bio-pharmaceutical related provisions H.R. 5982, Safe Medicine Act, regarding all bio-pharmaceutical related provisions H.R. 6049/S3343, Medical Supply Chain Security Act, regarding all bio-pharmaceutical related provisions H.R. 6080, Preventing Drug Shortages Act, regarding all bio-pharmaceutical , regarding all bio-pharmaceutical related provisions related provisions H.R. 6393, Strengthening America's Supply Chain and National Security Act, regarding all bio-pharmaceutical related provisions H.R.6399/S.3715 , SAVE Act of 2020, regarding all bio-pharmaceutical related provisions H.R. 6431, Made in America Emergency Preparedness Act, regarding all bio-pharmaceutical related provisions H.R. 6482, Protecting Our Pharmaceutical Supply Chain from China Act of 2020, regarding all bio-pharmaceutical related provisions H.R. 6670, Prescription for American Drug Independence Act of 2020, regarding all bio-pharmaceutical related provisions H.R. 6690, Bring Entrepreneurial Advancements To Consumers Here In North America Act ,regarding all bio-pharmaceutical related provisions H.R. 6708/S. 3432, Securing America's Medicine Cabinet Act of 2020, regarding all bio-pharmaceutical related provisions H.R. 6930, MADE in America Act of 2020, regarding all bio-pharmaceutical related provisions S. 3635, Protecting Our Pharmaceutical Supply Chain from China Act of 2020, regarding all bio-pharmaceutical related provisions S. 2723, Mitigating Emergency Drug Shortages Act, regarding all bio-pharmaceutical related provisions S.3945, Bring Entrepreneurial Advancements To Consumers Here In North America Act, regarding all bio-pharmaceutical related provisions

Drug shortage prevention H.R. 4866

Client expense: $230,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), General Services Administration (GSA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE

Compounding; Drug Pricing; Cures 2.0; CARES Act (S. 3548/H.R. 748); Additional COVID-19 pandemic response legislation; HEROES Act (H.R. 6800); National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act (H.R. 4866); FY 2021 appropriations; Health, Economic Assistance, Liability Protection and Schools (HEALS) Act.

Client expense: Not reported · Firm income: $40,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 36: Combating Sexual Harassment in Science Act of 2019 To provide for research to better understand the causes and consequences of sexual harassment affecting individuals in the scientific, technical, engineering, and mathematics workforce and to examine policies to reduce the prevalence and negative impact of such harassment, and for other purposes (ALL). H.R. 539 and S. 118: Innovators to Entrepreneurs Act of 2019 To require the Director of the National Science Foundation to develop an I-Corps course to support commercialization-ready innovation companies, and for other purposes (ALL). S. 937: Protecting American Technologies Act of 2019 A bill to direct the Secretary of Commerce to require institutions of higher education and other research facilities to obtain deemed export licenses for foreign nationals conducting scientific research at such institutions and facilities, and for other purposes (ALL). S. 2133: Secure American Research Act of 2019 A bill to establish an interagency working group for coordination and development of Federal research protection, and for other purposes (ALL). H.R. 4091 and S. 2714: ARPA-E Reauthorization Act of 2019 To amend the America COMPETES Act to reauthorize the ARPA-E program, and for other purposes (ALL). H.R. 3666 and S. 2082: Support Technology and Research for Our Nation's Growth and Economic Resilience (STRONGER) Patents Act of 2019 A bill to strengthen the position of the United States as the world's leading innovator by amending title 35, United States Code, to protect the property rights of the inventors that grow the country's economy (ALL). H.R. 4866: National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2019 To amend the 21st Century Cures Act to provide for designation of institutions of higher education that provide research, data, and leadership on continuous manufacturing as National Centers of Excellence in Continuous Pharmaceutical Manufacturing, and for other purposes (ALL). S. 3432: Securing America's Medicine Cabinet Act of 2020 A bill to support the advanced manufacturing technologies program of the Food and Drug Administration, to establish National Centers of Excellence in Advanced Pharmaceutical Manufacturing, and for other purposes (ALL). H.R. 7308: Research Investment to Spark the Economy (RISE) Act To authorize appropriations for offsetting the costs related to reductions in research productivity resulting from the coronavirus pandemic (ALL). S. 3997: Safeguarding American Innovation Act A bill to strengthen the security and integrity of the United States scientific and research enterprise (ALL). S. 4629: America Labor, Economic competitiveness, Alliances, Democracy and Security (America LEADS) Act A bill to address issues involving the People's Republic of China (provisions relating to scientific research funding, foreign gift reporting, and Chinese language and culture instruction). Federal policy changes regarding fetal tissue research.

Drug shortage prevention H.R. 4866

Client expense: $370,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), General Services Administration (GSA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE

Policy matters related to generic pharmaceuticals and biosimilars, including H. R. 985, the FAST Generics Act of 2019. H. R. 1499, the Protecting Consumer Access to Generic Drugs Act of 2019, and H. R. 938, the BLOCKING Act of 2019. Changes to the Risk Evaluation and Mitigation Strategies (REMS) program. Reimbursement rate for biosimilars. S. 1895, the Lower Health Care Costs Act, S.2543, The Prescription Drug Pricing Reduction Act, and H. R. 3,The Lower Drug Costs Now Act. H. R. 1865. Issues related to the implementation of H. R. 748, Coronavirus Aid, Relief, and Economic Security Act (CARES Act), including supply chain issues for generic medicines. Issues related to H.R.6395 and S.4049, National Defense Authorization Act for Fiscal Year 2021, including pharmaceutical supply chain provisions. Issues related to H.R. 4866, National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act, including domestic pharmaceutical manufacturing.

Client expense: Not reported · Firm income: $60,000

H.R. 2209, To establish the position of Chief Pharmaceutical Negotiator in the Office of the United States Trade Representative responsible for conducting trade negotiations and enforcing trade agreements related to acts, policies, and practices of foreign governments that fail to appropriately reward United States innovation with respect to pharmaceuticals, and for other purposes, regarding all bio-pharmaceutical related provisions. Unite States, Mexico, Canada Trade Agreement, regarding all bio-pharmaceutical related provisions. S. 3537, Protecting our Pharmaceutical Supply Chain from China Act of 2020, regarding all bio-pharmaceutical related provisions S. 3538, Strengthening Americas Supply Chain and National Security Act, regarding all bio-pharmaceutical related provisions No Bill, potential Buy American executive order for health-related goods, regarding all bio-pharmaceutical related provisions H.R. 4710, Pharmaceutical Independence Long-Term Readiness Reform Act, regarding all bio-pharmaceutical related provisions H.R. 4866, National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2019, regarding all bio-pharmaceutical related provisions H.R. 5381, International Pharmaceutical Transparency Act of 2019 , regarding all bio-pharmaceutical related provisions H.R. 5982, Safe Medicine Act, regarding all bio-pharmaceutical related provisions H.R. 6049/S3343, Medical Supply Chain Security Act, regarding all bio-pharmaceutical related provisions H.R. 6080, Preventing Drug Shortages Act, regarding all bio-pharmaceutical , regarding all bio-pharmaceutical related provisions related provisions H.R. 6393, Strengthening America's Supply Chain and National Security Act, regarding all bio-pharmaceutical related provisions H.R.6399/S.3715 , SAVE Act of 2020, regarding all bio-pharmaceutical related provisions H.R. 6431, Made in America Emergency Preparedness Act, regarding all bio-pharmaceutical related provisions H.R. 6482, Protecting Our Pharmaceutical Supply Chain from China Act of 2020, regarding all bio-pharmaceutical related provisions H.R. 6670, Prescription for American Drug Independence Act of 2020, regarding all bio-pharmaceutical related provisions H.R. 6690, Bring Entrepreneurial Advancements To Consumers Here In North America Act ,regarding all bio-pharmaceutical related provisions H.R. 6708/S. 3432, Securing America's Medicine Cabinet Act of 2020, regarding all bio-pharmaceutical related provisions H.R. 6930, MADE in America Act of 2020, regarding all bio-pharmaceutical related provisions S. 3635, Protecting Our Pharmaceutical Supply Chain from China Act of 2020, regarding all bio-pharmaceutical related provisions S. 2723, Mitigating Emergency Drug Shortages Act, regarding all bio-pharmaceutical related provisions S.3945, Bring Entrepreneurial Advancements To Consumers Here In North America Act, regarding all bio-pharmaceutical related provisions

H.R. 36: Combating Sexual Harassment in Science Act of 2019 To provide for research to better understand the causes and consequences of sexual harassment affecting individuals in the scientific, technical, engineering, and mathematics workforce and to examine policies to reduce the prevalence and negative impact of such harassment, and for other purposes (ALL). H.R. 539 and S. 118: Innovators to Entrepreneurs Act of 2019 To require the Director of the National Science Foundation to develop an I-Corps course to support commercialization-ready innovation companies, and for other purposes (ALL). S. 937: Protecting American Technologies Act of 2019 A bill to direct the Secretary of Commerce to require institutions of higher education and other research facilities to obtain deemed export licenses for foreign nationals conducting scientific research at such institutions and facilities, and for other purposes (ALL). S. 2133: Secure American Research Act of 2019 A bill to establish an interagency working group for coordination and development of Federal research protection, and for other purposes (ALL). H.R. 4091 and S. 2714: ARPA-E Reauthorization Act of 2019 To amend the America COMPETES Act to reauthorize the ARPA-E program, and for other purposes (ALL). H.R. 3666 and S. 2082: Support Technology and Research for Our Nation's Growth and Economic Resilience (STRONGER) Patents Act of 2019 A bill to strengthen the position of the United States as the world's leading innovator by amending title 35, United States Code, to protect the property rights of the inventors that grow the country's economy (ALL). H.R. 4866: National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2019 To amend the 21st Century Cures Act to provide for designation of institutions of higher education that provide research, data, and leadership on continuous manufacturing as National Centers of Excellence in Continuous Pharmaceutical Manufacturing, and for other purposes (ALL). S. 3432: Securing America's Medicine Cabinet Act of 2020 A bill to support the advanced manufacturing technologies program of the Food and Drug Administration, to establish National Centers of Excellence in Advanced Pharmaceutical Manufacturing, and for other purposes (ALL). H.R. 7308: Research Investment to Spark the Economy (RISE) Act To authorize appropriations for offsetting the costs related to reductions in research productivity resulting from the coronavirus pandemic (ALL). S. 3997: Safeguarding American Innovation Act A bill to strengthen the security and integrity of the United States scientific and research enterprise (ALL). H.R. 6800: Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act Vehicle for the fourth coronavirus supplemental relief package (provisions relating to relief for medical and scientific research and continuous pharmaceutical manufacturing). Pending federal policy changes regarding fetal tissue research.

Pub.L. 116-136; CARES Act; implementation as it relates to supporting public health infrastructure. HR 4866; National Centers of Excellence in Continuous Manufacturing act; all provisions. S. 3432; Securing America's Medicine Cabinet Act; all provisions.

Client expense: $130,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Drug shortage prevention H.R. 4866

Client expense: $260,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), General Services Administration (GSA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE

H.R. 2209, To establish the position of Chief Pharmaceutical Negotiator in the Office of the United States Trade Representative responsible for conducting trade negotiations and enforcing trade agreements related to acts, policies, and practices of foreign governments that fail to appropriately reward United States innovation with respect to pharmaceuticals, and for other purposes, regarding all bio-pharmaceutical related provisions. Unite States, Mexico, Canada Trade Agreement, regarding all bio-pharmaceutical related provisions. S. 3537, Protecting our Pharmaceutical Supply Chain from China Act of 2020, regarding all bio-pharmaceutical related provisions S. 3538, Strengthening Americas Supply Chain and National Security Act, regarding all bio-pharmaceutical related provisions No Bill, potential Buy American executive order for health-related goods, regarding all bio-pharmaceutical related provisions H.R. 4710, Pharmaceutical Independence Long-Term Readiness Reform Act, regarding all bio-pharmaceutical related provisions H.R. 4866, National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2019, regarding all bio-pharmaceutical related provisions H.R. 5381, International Pharmaceutical Transparency Act of 2019 , regarding all bio-pharmaceutical related provisions H.R. 5982, Safe Medicine Act, regarding all bio-pharmaceutical related provisions H.R. 6049/S3343, Medical Supply Chain Security Act, regarding all bio-pharmaceutical related provisions H.R. 6080, Preventing Drug Shortages Act, regarding all bio-pharmaceutical , regarding all bio-pharmaceutical related provisions related provisions H.R. 6393, Strengthening America's Supply Chain and National Security Act, regarding all bio-pharmaceutical related provisions H.R.6399/S.3715 , SAVE Act of 2020, regarding all bio-pharmaceutical related provisions H.R. 6431, Made in America Emergency Preparedness Act, regarding all bio-pharmaceutical related provisions H.R. 6482, Protecting Our Pharmaceutical Supply Chain from China Act of 2020, regarding all bio-pharmaceutical related provisions H.R. 6670, Prescription for American Drug Independence Act of 2020, regarding all bio-pharmaceutical related provisions H.R. 6690, Bring Entrepreneurial Advancements To Consumers Here In North America Act ,regarding all bio-pharmaceutical related provisions H.R. 6708/S. 3432, Securing America's Medicine Cabinet Act of 2020, regarding all bio-pharmaceutical related provisions H.R. 6930, MADE in America Act of 2020, regarding all bio-pharmaceutical related provisions S. 3635, Protecting Our Pharmaceutical Supply Chain from China Act of 2020, regarding all bio-pharmaceutical related provisions S. 2723, Mitigating Emergency Drug Shortages Act, regarding all bio-pharmaceutical related provisions S.3945, Bring Entrepreneurial Advancements To Consumers Here In North America Act, regarding all bio-pharmaceutical related provisions

H.R. 36: Combating Sexual Harassment in Science Act of 2019 To provide for research to better understand the causes and consequences of sexual harassment affecting individuals in the scientific, technical, engineering, and mathematics workforce and to examine policies to reduce the prevalence and negative impact of such harassment, and for other purposes (ALL). H.R. 539 and S. 118: Innovators to Entrepreneurs Act of 2019 To require the Director of the National Science Foundation to develop an I-Corps course to support commercialization-ready innovation companies, and for other purposes (ALL). S. 937: Protecting American Technologies Act of 2019 A bill to direct the Secretary of Commerce to require institutions of higher education and other research facilities to obtain deemed export licenses for foreign nationals conducting scientific research at such institutions and facilities, and for other purposes (ALL). S. 2133: Secure American Research Act of 2019 A bill to establish an interagency working group for coordination and development of Federal research protection, and for other purposes (ALL). H.R. 4091 and S. 2714: ARPA-E Reauthorization Act of 2019 To amend the America COMPETES Act to reauthorize the ARPA-E program, and for other purposes (ALL). H.R. 3666 and S. 2082: Support Technology and Research for Our Nation's Growth and Economic Resilience (STRONGER) Patents Act of 2019 A bill to strengthen the position of the United States as the world's leading innovator by amending title 35, United States Code, to protect the property rights of the inventors that grow the country's economy (ALL). H.R. 4866: National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2019 To amend the 21st Century Cures Act to provide for designation of institutions of higher education that provide research, data, and leadership on continuous manufacturing as National Centers of Excellence in Continuous Pharmaceutical Manufacturing, and for other purposes (ALL). Pending federal policy changes regarding fetal tissue research.

Drug shortage prevention H.R. 4866

Client expense: $310,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), General Services Administration (GSA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE

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

H.R. 3038: Securing American Science and Technology Act of 2019 To establish an interagency working group to coordinate activities and develop policy guidance to protect federally funded research and development from foreign interference, and for other purposes (ALL). H.R. 36: Combating Sexual Harassment in Science Act of 2019 To provide for research to better understand the causes and consequences of sexual harassment affecting individuals in the scientific, technical, engineering, and mathematics workforce and to examine policies to reduce the prevalence and negative impact of such harassment, and for other purposes (ALL). H.R. 539 and S. 118: Innovators to Entrepreneurs Act of 2019 To require the Director of the National Science Foundation to develop an I-Corps course to support commercialization-ready innovation companies, and for other purposes (ALL). S. 937: Protecting American Technologies Act of 2019 A bill to direct the Secretary of Commerce to require institutions of higher education and other research facilities to obtain deemed export licenses for foreign nationals conducting scientific research at such institutions and facilities, and for other purposes (ALL). S. 2133: Secure American Research Act of 2019 A bill to establish an interagency working group for coordination and development of Federal research protection, and for other purposes (ALL). H.R. 4091 and S. 2714: ARPA-E Reauthorization Act of 2019 To amend the America COMPETES Act to reauthorize the ARPA-E program, and for other purposes (ALL). H.R. 3666 and S. 2082: Support Technology and Research for Our Nation's Growth and Economic Resilience (STRONGER) Patents Act of 2019 A bill to strengthen the position of the United States as the world's leading innovator by amending title 35, United States Code, to protect the property rights of the inventors that grow the country's economy (ALL). H.R. 4866: National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2019 To amend the 21st Century Cures Act to provide for designation of institutions of higher education that provide research, data, and leadership on continuous manufacturing as National Centers of Excellence in Continuous Pharmaceutical Manufacturing, and for other purposes (ALL). H.R. 150: Grant Reporting Efficiency and Agreements Transparency Act of 2019 To modernize Federal grant reporting, and for other purposes (ALL). Pending federal policy changes regarding fetal tissue research

S. 1895, Lower Health Care Costs Act; Section 207 Cures 2.0 H.R. 4866, Continuous Pharmaceutical Manufacturing

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE