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Make Medications Affordable by Preventing Pandemic Price gouging Act of 2020 or the MMAPPP Act of 2020 This bill imposes licensing and price restrictions on federally supported drugs and other medicines intended to address COVID-19 (i.e., coronavirus disease 2019) or other public health emergencies. With respect to a COVID-19 drug patent developed using certain types of federal support, any license granted by the federal government shall be open and nonexclusive. Similarly, a licensee or assignee for such a patent shall grant open nonexclusive licenses for the patent. An entity that receives a license shall pay reasonable royalties to (1) the patent holder, or (2) the owner of marketing exclusivity rights granted by the Food and Drug Administration (FDA) that were terminated under this bill. The bill requires that such drugs be offered at a fair and reasonable price based on certain considerations, such as access. If the Department of Health and Human Services (HHS) finds that the price of any drug to address a public health emergency is excessive, HHS must void any FDA-granted exclusivity for the drug and grant open and nonexclusive licenses to other manufacturers. Such licenses are subject to reasonable royalty requirements.
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Filing registrants (4)
2020 · fourth_quarter · Pharmacy
H.R. 3 - Lower Drug Costs Now Act of 2019 - Pallone - drug pricing H.R. 4398 - Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 - Cicilline - drug pricing H.R. 4906 - Insulin Price Reduction Act - DeGette - insulin costs H.R. 5444 - Lower Insulin Costs Now Act - Underwood - lowering insulin costs H.R. 5749 - Affordable Insulin for All Act - Crist - insulin costs H.R. 6155 - To amend the Biologics Price Competition and Innovation Act of 2009 to make improvements with respect to the transition of biological products - Grothman - biological products H.R. 6411 - To require group health plans and health insurance issuers offering group or individual coverage to provide notices relating to prescription drug refills to individuals covered under such plans or coverage who reside in emergency areas during emergency periods - McBath - prescription drug refill notices H.R. 6649 - Lower Drug Costs for Seniors During COVID-19 Act of 2020 -Schakowsky - COVID H.R. 6739- Ensuring Seniors' Access to COVID Treatments Act - Casten - COVID H.R. 7062 - Affordable Insulin for the COVID-19 Emergency Act - Waters - Insulin/COVID H.R. 8190 - Biosimilar Insulin Access Act of 2020 - Grothman - insulin biosimilar S. 2543 - Prescription Drug Pricing Reduction Act of 2019 - Grassley - Drug pricing S. 3092 - Expanding Access to Low-Cost Generics Act of 2019 - Smith - 180-day exclusivity period S. 3166 - Prescription Drug Affordability and Access Act - Booker - prescription drug costs S. 3781 - PART Act - Peters - transparency S. 4134 - Increasing Access to Biosimilars Act of 2020 - Cornyn - CMS demonstration project; provider payments for providing biosimilars S. 4199 - Prescription Drug Pricing Reduction Act of 2020 - Grassley - lower drug prices in Medicare and Medicaid/ transparency S. 4439 - Make Medications Affordable by Preventing Pandemic Price-gouging Act of 2020 - Smith - COVID-19 drug be affordable and accessible Regulatory Issues: Issues relating to long term safety and effectiveness of medical devices and drugs, including registries; issues relating to post-market surveillance of drugs and medical devices; issues relating to price of drugs and biologics and proposals to limit high prices; issues related to prescription drug coupons and discount programs; issues relating to vaccines; Executive Orders relating to international pricing, Part D rebates, insulin costs, and importation; issues related to drug patents and market exclusivity; issues related to pharmacy benefit managers; issues related to biosimilars; issues related to approval of drugs and biologics; issues relating to opioids; issues relating to COVID-19, including vaccines and therapeutics; issues related to health care price transparency; issues relating to prescription drug rebates; issues relating to prescription drug price blueprint; direct-to-consumer advertising for prescription drugs; issues related to proposed changes to removal of safe harbor protection for rebates (proposed rule); issues relating to access for investigational drugs; and other issues relating to health care reform implementation.
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Introduced in Senate
Bills with similar content found using semantic analysis.
Sources: Congress.gov
Client expense: $2,400,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Council of Economic Advisers (CEA), Executive Office of the President (EOP), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Office of the Vice President of the United States, SENATE, Treasury, Dept of, White House Office
2020 · fourth_quarter · Pharmacy
Medicare drug price regulation, HR 7296/S 4439 (MMAAPP Act), HR 7288/S 4539 (TRACK Act), transparency for federally support COVID R&D,COVID-19 Medicine pricing and access, HR 4663-Freedom from Price Gouging Act, HR 1093/S 378-Stop Price Gouging Act, S 3847/HR 7113 (COVID 19 Emergency Manufacturing Act, CARES 2.0-S.1712/HR4100-DISARM Act, S 4760-PASTEUR Act, Antibiotic drug development, Prescription drug transparency, S 1416/HR 5133, S-64,HR-2374,HR-3379-Pharma competition legislation, Medicare Part B drug reimbursement
Client expense: $130,000 · Firm income: Not reported
Government targets: Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)
2020 · third_quarter · Health Issues
H.R. 985: FAST Generics Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 4100: DISARM Act of 2019 - Provisions related to antimicrobial drug development H.R. 5668: MODERN Labeling Act of 2020 - Provisions related to prescription drug labeling H.R. 6080: Preventing Drug Shortages Act - Provisions related to prescription drug shortage reporting requirements H.R. 6222: Ensuring Affordable COVID-19 Preventive Care Act of 2020 - Provisions related to prescription drug pricing and access H.R. 6231: Ensuring Access to COVID-19 Preventive Care Act of 2020 - Provisions related to prescription drug pricing and access H.R. 6260: Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavi-rus Patients Act of 2020 - Provisions related to FDA prescription drug marketing approvals H.R. 6390: To require the President to use authorities under the Defense Production Act of 1950 to require emergency production of medical equipment to address the COVID-19 outbreak - Provisions related to the Defense Production Act H.R. 6410: To direct the President to use authority under the Defense Production Act of 1950 to ensure an adequate supply equipment necessary for limiting the spread of COVID-19 - Provisions related to the Defense Production Act H.R. 6450: Price Gouging Prevention Act - Provisions related to prescription drug and medical device pricing H.R. 6906: Health Care Emergency Guarantee Act - Provisions related to prescription drug access and cost sharing H.R. 7288: Taxpayer Research and Coronavirus Knowledge Act of 2020 - Provisions related to prescription drug research and development and transparency H.R. 7296: MMAPPP Act of 2020 - Provisions related to prescription drug pricing and transparency 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 - Provisions related to accumulator adjustment programs H.R. 7676: Health Care PRICE Transparency Act - Provisions related to hospital & insurer price transparency H.R. 7838: To provide for certain temporary waivers with respect to the 340B drug discount program due to the COVID-19 public health emergency, and for other purposes - Provisions related to the 340B drug discount program H.R. 7942: Public Health Emergency COBRA Extension Act - Provisions related to health insurance coverage S. 1532: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 1712: DISARM Act of 2019 - Provisions related to antimicrobial drug development S. 2161: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 - Provisions related to reciprocity S. 2304: Strategies To Address Antibiotic Resistance Act - Provisions related to antimicrobial resistance (AMR) and other issues S. 3384: Lowering Prescription Drug Prices for America's Seniors and Families Act of 2020 - Provisions related to prescription drug price negotiation, importation, and other issues S. 3545: Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Corona-virus Patients Act of 2020 - Provisions related to FDA prescription drug marketing approvals S. 3872: Promising Pathway Act - Provisions related to FDA provisional approval pathways Transparency policy issues S. 3932: A bill to direct the Secretary of Defense to carry out a pilot program under the TRICARE pharmacy benefits program - Provisions related to DoD TRICARE pharmacy benefits program S. 4439: MMAPPP Act of 2020 - Provisions related to prescription drug pricing and transparency S. 4492: Safe Drugs Act - Provisions related to FDA prescription drug mandatory recalls Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 (discussion draft) Proclamation Suspending Entry of Aliens Who Present a Risk to the U.S. Labor Market Following the Coronavirus Outbreak (June 22, 2020) Department of Homeland Security cybersecurity policy issues HHS PREP Act declaration relating to COVID-19 Drug cost and pricing policy issues Drug importation and counterfeiting policy issues HHS Safe Importation Action Plan Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues FDA modernization policy issues 340B drug discount program policy issues Patient assistance program policy issues Foreign manufacturing policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Proposed Rule; Importation of Prescription Drugs (RIN 0910-AI45) Executive Order 13951, An America-First Healthcare Plan (September 24, 2020) Executive Order 13948, Lowering Drug Prices by Putting America First (September 13, 2020) - Provisions on Part B and D, Most Favored Nation, and other issues Executive Order 13944, Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States (August 6, 2020) Executive Order 13939, Lowering Drug Prices for Patients by Eliminating Kickbacks to Middlemen (July 24, 2020) Executive Order 13938, Increasing Drug Importation to Lower Prices for American Patients (July 24, 2020) Executive Order 13937, Access to Affordable Life-saving Medications (July 24, 2020) Proposed Rule; Implementation of Executive Order 13937, Executive Order on Access to Affordable Life-Saving Medications (RIN 0906-AB25) Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients
Client expense: $1,210,000 · 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)
2020 · third_quarter · Health Issues
H.R. 985: FAST Generics Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 4100: DISARM Act of 2019 - Provisions related to antimicrobial drug development H.R. 5668: MODERN Labeling Act of 2020 - Provisions related to prescription drug labeling H.R. 6080: Preventing Drug Shortages Act - Provisions related to prescription drug shortage reporting requirements H.R. 6222: Ensuring Affordable COVID-19 Preventive Care Act of 2020 - Provisions related to prescription drug pricing and access H.R. 6231: Ensuring Access to COVID-19 Preventive Care Act of 2020 - Provisions related to prescription drug pricing and access H.R. 6260: Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavirus Patients Act of 2020 - Provisions related to FDA prescription drug marketing approvals H.R. 6390: To require the President to use authorities under the Defense Production Act of 1950 to require emergency production of medical equipment to address the COVID-19 outbreak - Provisions related to the Defense Production Act H.R. 6410: To direct the President to use authority under the Defense Production Act of 1950 to ensure an adequate supply equipment necessary for limiting the spread of COVID-19 - Provisions related to the Defense Production Act H.R. 6450: Price Gouging Prevention Act - Provisions related to prescription drug and medical device pricing H.R. 6906: Health Care Emergency Guarantee Act - Provisions related to prescription drug access and cost sharing H.R. 7288: Taxpayer Research and Coronavirus Knowledge Act of 2020 - Provisions related to prescription drug research and development and transparency H.R. 7296: MMAPPP Act of 2020 - Provisions related to prescription drug pricing and transparency 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 - Provisions related to accumulator adjustment programs H.R. 7676: Health Care PRICE Transparency Act - Provisions related to hospital & insurer price transparency H.R. 7838: To provide for certain temporary waivers with respect to the 340B drug discount program due to the COVID-19 public health emergency, and for other purposes - Provisions related to the 340B drug discount program H.R. 7942: Public Health Emergency COBRA Extension Act - Provisions related to health insurance coverage S. 1532: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 1712: DISARM Act of 2019 - Provisions related to antimicrobial drug development S. 2161: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 - Provisions related to reciprocity S. 2304: Strategies To Address Antibiotic Resistance Act - Provisions related to antimicrobial resistance (AMR) and other issues S. 3384: Lowering Prescription Drug Prices for America's Seniors and Families Act of 2020 - Provisions related to prescription drug price negotiation, importation, and other issues S. 3545: Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavirus Patients Act of 2020 - Provisions related to FDA prescription drug marketing approvals S. 3872: Promising Pathway Act - Provisions related to FDA provisional approval pathways S. 3932: A bill to direct the Secretary of Defense to carry out a pilot program under the TRICARE pharmacy benefits program - Provisions related to DoD TRICARE pharmacy benefits program S. 4439: MMAPPP Act of 2020 - Provisions related to prescription drug pricing and transparency S. 4492: Safe Drugs Act - Provisions related to FDA prescription drug mandatory recalls Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 (discussion draft) Proclamation Suspending Entry of Aliens Who Present a Risk to the U.S. Labor Market Following the Coronavirus Outbreak (June 22, 2020) Department of Homeland Security cybersecurity policy issues HHS PREP Act declaration relating to COVID-19 Drug cost and pricing policy issues Transparency policy issues Drug importation and counterfeiting policy issues HHS Safe Importation Action Plan Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues FDA modernization policy issues 340B drug discount program reform and policy issues Patient assistance program policy issues Foreign manufacturing policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Proposed Rule; Importation of Prescription Drugs (RIN 0910-AI45) Executive Order 13951, An America-First Healthcare Plan (September 24, 2020) Executive Order 13948, Lowering Drug Prices by Putting America First (September 13, 2020) - Provisions on Part B and D, Most Favored Nation, and other issues Executive Order 13944, Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States (August 6, 2020) Executive Order 13939, Lowering Drug Prices for Patients by Eliminating Kickbacks to Middlemen (July 24, 2020) Executive Order 13938, Increasing Drug Importation to Lower Prices for American Patients (July 24, 2020) Executive Order 13937, Access to Affordable Life-saving Medications (July 24, 2020) Proposed Rule; Implementation of Executive Order 13937, Executive Order on Access to Affordable Life-Saving Medications (RIN 0906-AB25) Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients
Client expense: $5,960,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Economic Council (NEC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR)
2020 · third_quarter · Pharmacy
H.R. 3 - Lower Drug Costs Now Act of 2019 - Pallone - drug pricing H.R. 4398 - Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 - Cicilline - drug pricing H.R. 4906 - Insulin Price Reduction Act - DeGette - insulin costs H.R. 5444 - Lower Insulin Costs Now Act - Underwood - lowering insulin costs H.R. 5749 - Affordable Insulin for All Act - Crist - insulin costs H.R. 6155 - To amend the Biologics Price Competition and Innovation Act of 2009 to make improvements with respect to the transition of biological products - Grothman - biological products H.R. 6411 - To require group health plans and health insurance issuers offering group or individual coverage to provide notices relating to prescription drug refills to individuals covered under such plans or coverage who reside in emergency areas during emergency periods - McBath - prescription drug refill notices H.R. 6649 - Lower Drug Costs for Seniors During COVID-19 Act of 2020 -Schakowsky - COVID H.R. 6739- Ensuring Seniors' Access to COVID Treatments Act - Casten - COVID H.R. 7062 - Affordable Insulin for the COVID-19 Emergency Act - Waters - Insulin/COVID H.R. 8190 - Biosimilar Insulin Access Act of 2020 - Grothman - insulin biosimilar S. 2543 - Prescription Drug Pricing Reduction Act of 2019 - Grassley - Drug pricing S. 3092 - Expanding Access to Low-Cost Generics Act of 2019 - Smith - 180-day exclusivity period S. 3166 - Prescription Drug Affordability and Access Act - Booker - prescription drug costs S. 3781 - PART Act - Peters - transparency S. 4134 - Increasing Access to Biosimilars Act of 2020 - Cornyn - CMS demonstration project; provider payments for providing biosimilars S. 4199 - Prescription Drug Pricing Reduction Act of 2020 - Grassley - lower drug prices in Medicare and Medicaid/ transparency S. 4439 - Make Medications Affordable by Preventing Pandemic Price-gouging Act of 2020 - Smith - COVID-19 drug be affordable and accessible Regulatory Issues: Issues relating to long term safety and effectiveness of medical devices and drugs, including registries; issues relating to post-market surveillance of drugs and medical devices; issues relating to price of drugs and biologics and proposals to limit high prices; issues related to prescription drug coupons and discount programs; issues relating to vaccines; Executive Orders relating to international pricing, Part D rebates, insulin costs, and importation; issues related to drug patents and market exclusivity; issues related to pharmacy benefit managers; issues related to biosimilars; issues related to approval of drugs and biologics; issues relating to opioids; issues relating to COVID-19, including vaccines and therapeutics; issues relating to prescription drug rebates; issues relating to prescription drug price blueprint; direct-to-consumer advertising for prescription drugs; issues related to proposed changes to removal of safe harbor protection for rebates (proposed rule); issues relating to access for investigational drugs; and other issues relating to health care reform implementation.
Client expense: $2,230,000 · 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), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), SENATE, Treasury, Dept of, White House Office
| Democratic |
| CA |
| Kirsten E. Gillibrand | Democratic | NY |
| Tammy Baldwin | Democratic | WI |