Drug Safety, Medical Device, And Laboratory Regulation
US Congress 116th Congress
Comprehensive Addiction Resources Emergency Act of 2019 [S.1365]
Establishes various programs to address substance use disorder and opioid addiction, including grants for treatment, recovery, and harm reduction services as well as a program to distribute overdose reversal drugs.
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Modernizing Drug Enforcement Act of 2019 [HB-2580]
Deems a drug or substance that acts as an opioid mu receptor agonist (e.g., morphine) to be in schedule I of the Controlled Substances Act, subject to certain exceptions. A schedule I controlled substance is a drug, substance, or chemical that has a high potential for abuse; has no currently accepted medical value; and is subject to regulatory controls and administrative, civil, and criminal penalties under the Controlled Substances Act.
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US Congress 116th Congress
Newborn Screening Saves Lives Reauthorization Act of 2019 [HB-2507]
Reauthorizes through FY2024 and revises several programs and activities relating to newborn screening for genetic diseases. Among other things, the bill reauthorizes, and makes mandatory rather than discretionary, the Hunter Kelly Research Program at the National Institutes of Health as well as national surveillance activities conducted by the Centers for Disease Control and Prevention.
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Ensuring Timely Access to Generics Act of 2019 [HB-2455]
To amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions.
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Medicare for America Act of 2019 [HB-2452]
Establishes several health insurance programs and otherwise modifies certain requirements relating to health care coverage, costs, and services. In particular, the bill establishes a national health insurance program to be administered by the Department of Health and Human Services (HHS). Among other requirements, the program must (1) cover all U.S. residents; (2) cover specified items and services, including hospital services, prescription drugs, dental services, and home- and community-based long-term care; and (3) be fully implemented in 2023.
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Ensuring Access to Quality Complex Rehabilitation Technology Act of 2019 [HB-2408]
Establishes a specific benefit category (i.e., classification) for complex rehabilitation technology items under Medicare. The Centers for Medicare & Medicaid Services must set payment for such items in accordance with a specified methodology that includes certain clinical conditions and quality standards. The bill also excludes such items from Medicare's competitive acquisition program (in which rates are set through a competitive bidding program rather than by an established fee schedule). The bill defines complex rehabilitation technology item
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Stop STALLING Act Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act [S.1224]
A bill to enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition, and facilitate the efficient review of petitions filed in good faith to raise legitimate public health concerns, and for other purposes.
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Stop STALLING Act Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act [HB-2374]
To enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition and facilitate the efficient review of petitions filed in good faith to raise legitimate public heath concerns, and for other purposes.
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Protecting American Lungs and Reversing the Youth Tobacco Epidemic Act of 2020 [HB-2339]
Revises requirements related to the safety, sale, and advertisement of tobacco products, including electronic nicotine delivery systems (e.g., e-cigarettes, e-hookah, e-cigars, and vape pens). Among other requirements, the bill requires the Food and Drug Administration (FDA) to implement regulations to require color graphics on the labeling of cigarette packages, depicting the negative health consequences of smoking; requires the FDA to apply regulations on tobacco products to all tobacco products, including e-cigarettes; generally prohibits the
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Stephen Hacala Poppy Seed Safety Act [HB-2078]
To prohibit the sale of food that is, or contains, unsafe poppy seeds.
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Supporting State, local, and community initiatives to encourage parents, teachers, camp counselors, and childcare professionals to take measures to prevent sunburns in the minors they care for, and expressing the sense of the House of Representatives that State, local, and community entities should continue to support efforts to curb the incidences of skin cancer beginning with childhood skin protection. [HR-323]
This resolution expresses support for efforts to (1) exempt sunscreen from over-the-counter medication bans in schools, and (2) encourage health care professionals to educate parents and children about sun-safe behaviors. Additionally, the resolution encourages schools to allow students to possess sunscreen without restriction and without physician authorization.
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Protecting Access to Biosimilars Act of 2019 [HB-2011]
To amend the Public Health Service Act with respect to the treatment under section 351(k)(7) of such Act (relating to exclusivity for reference products) of certain products deemed to have a biologics license pursuant to section 7002 of the Biologics Price Competition and Innovation Act of 2009.
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Ensuring Timely Access to Generics Act of 2019 [S.1169]
A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions.
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REMEDY Act Reforming Evergreening and Manipulation that Extends Drug Years Act [S.1209]
A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to approval of abbreviated new drug applications.
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Protecting Access to Biosimilars Act of 2019 [S.1140]
Excludes biological products that were initially licensed under the Federal Food, Drug, and Cosmetic Act (FD&C Act) (e.g., insulin) from the exclusivity protections that delay the licensure of biosimilar products under the Public Health Service Act (PHS Act). (The Biologics Price Competition and Innovation Act of 2009 generally requires that biological products approved under the FD&C Act are treated as though they were approved under the PHS Act through March 23, 2020.)
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A resolution recognizing the importance of vaccinations and immunizations in the United States. [SR-165]
This resolution affirms that vaccines and immunizations save lives and commends those who have worked to bolster global and domestic health through vaccination.
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Menstrual Products Right To Know Act of 2019 [HB-2268]
To amend the Federal Food, Drug, and Cosmetic Act to treat certain menstrual products as misbranded if their labeling does not list each ingredient or component of the product, and for other purposes.
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Gluten in Medicine Disclosure Act of 2019 [HB-2074]
To amend the Federal Food, Drug, and Cosmetic Act to require the label of a drug that is intended for human use and contains an ingredient that is derived directly or indirectly from a gluten-containing grain to identify each such ingredient, and for other purposes.
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Stephen Hacala Poppy Seed Safety Act [S.1016]
A bill to prohibit the sale of food that is, or contains, unsafe poppy seeds.
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Preserving Patient Access to Compounded Medications Act of 2019 [HB-1959]
To amend the Federal Food, Drug, and Cosmetic Act with respect to compounding pharmacies, and for other purposes.