Drug Safety, Medical Device, And Laboratory Regulation
US Congress 116th Congress
Protecting American Lungs Act of 2019 [HB-4742]
Imposes an excise tax on "taxable nicotine" which is any nicotine that has been extracted, concentrated, or synthesized and is treated as a tobacco product. The tax does not apply to nicotine used in a product that has been approved by the Food and Drug Administration for sale as a nicotine replacement therapy.
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Fairness in Orphan Drug Exclusivity Act [HB-4712]
To amend the Federal Food, Drug, and Cosmetic Act with respect to limitations on exclusive approval or licensure of orphan drugs, and for other purposes.
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Pharmaceutical Independence Long-Term Readiness Reform Act [HB-4710]
To direct the Secretary of Defense to include in each national defense strategy steps to strengthen the United States industrial base and to assure an uninterrupted supply of medicines, and for other purposes.
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Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2019 [HB-4640]
To require persons who undertake Federally funded research and development of drugs to enter into reasonable pricing agreements with the Secretary of Health and Human Services.
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Investing in Safety and Innovation Act of 2019 [HB-4633]
To amend the 21st Century Cures Act to reauthorize funding for FDA innovation projects, and for other purposes.
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Biomedical Innovation Expansion Act of 2019 [HB-4667]
Expands and reauthorizes through FY2030 the National Institutes of Health innovation projects, which include the (1) All of Us Research Programs, (2) Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative, (3) Cancer Moonshot research, and (4) Regenerative Medicine Innovation Project. The bill also provides new funding for antimicrobial resistance research and for the research of rare diseases or conditions.
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END ENDS Act of 2019 Ending Nicotine Dependence from Electronic Nicotine Delivery Systems Act of 2019 [HB-4624]
To amend the Federal Food, Drug, and Cosmetic Act to establish a tobacco product standard prohibiting any e-liquid with a concentration of nicotine higher than 20 milligrams per milliliter, and for other purposes.
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Adding Epidemic Diseases to the FDA Priority Review Voucher Program Act [HB-4553]
Expands the priority-review voucher program for tropical diseases to include Middle East respiratory syndrome, Nipah virus, and Rift Valley fever. A voucher entitles the holder to have a future new drug or biological product application acted upon by the Food and Drug Administration within six months.
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Prescription Drug Pricing Reduction Act of 2019 [S.2543]
Alters several programs and requirements relating to the prices of prescription drugs under Medicare and Medicaid. Among other things, the bill requires drug manufacturers to issue rebates to the Centers for Medicare & Medicaid Services (CMS) for certain drugs covered under Medicare for which the average manufacturer price increases faster than inflation; requires drug manufacturers to issue rebates to the CMS for discarded amounts of certain single-dose drugs covered under Medicare, based on information reported by providers; reduces the annual
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Turn the Tide Act [HB-4460]
Funds through FY2023 the SUPPORT for Patients and Communities Act, which established various programs to address opioid addiction. Funded programs include (1) grants to increase access to substance use disorder treatments; (2) research, training, and developing best practices within the public health sector; (3) prevention and recovery services for youth, women, and infants; (4) overdose prevention and treatment; and (5) other community, judicial, and administrative programs. The bill also reauthorizes through FY2024 and increases funding for the
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E-Cigarette Device Standards Act of 2019 [S.2536]
A bill to establish standards for the design of electronic nicotine delivery systems.
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Creating Hope Reauthorization Act [HB-4439]
To amend the Federal Food, Drug, and Cosmetic Act to make permanent the authority of the Secretary of Health and Human Services to issue priority review vouchers to encourage treatments for rare pediatric diseases.
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Advancing Education on Biosimilars Act of 2019 [HB-4400]
Requires the Department of Health and Human Services (HHS) to maintain a website and undertake other activities to educate health care providers, patients, and caregivers about biological products, biosimilar biological products, and interchangeable biosimilar biological products. Among other activities, HHS must develop or improve continuing education programs that address clinical considerations for biological and related products. Health care providers eligible for the Merit-based Incentive Payment System in Medicare may count completion of such
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ENND Act Ending New Nicotine Dependencies Act of 2019 [S.2519]
A bill to protect the public health by prohibiting non-tobacco e-cigarette flavors and ensuring electronic nicotine delivery systems are tamper-proof.
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Depression Side Effect Labeling Awareness Act of 2019 [HB-4404]
To amend the Federal Food, Drug, and Cosmetic Act to require that the label of drugs with an increased risk of suicide or depression present such increased risk prominently, and for other purposes.
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Elijah E. Cummings Lower Drug Costs Now Act [HB-3]
Establishes several programs and requirements relating to the prices of prescription drugs, health care coverage and costs, and public health. TITLE I--LOWERING PRICES THROUGH FAIR DRUG PRICE NEGOTIATION The bill requires the Department of Health and Human Services (HHS) to negotiate prices for certain drugs. (Under current law, HHS may not negotiate the prices of covered drugs under the Medicare prescription drug benefit.) Specifically, HHS must negotiate maximum prices for (1) insulin products; (2) with respect to FY2023, at least 25 single-source,
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Expanding Cannabis Research and Information Act [S.2400]
Changes marijuana from a Schedule I to a Schedule III controlled substance, which allows it to be dispensed, subject to certain limitations, for accepted medical uses with a written or oral prescription.The bill also requires the National Institutes of Health (NIH) to collaborate with specified agencies to develop a national cannabis research agenda that must address (1) the therapeutic benefits of cannabis, (2) how it effects specified populations, (3) its long-term effects, (4) clinically appropriate methods to deliver it to the body, and (5)
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Expanding Cannabis Research and Information Act [HB-4322]
Changes marijuana from a Schedule I to a Schedule III controlled substance, which allows it to be dispensed, subject to certain limitations, for accepted medical uses with a written or oral prescription.The bill also requires the National Institutes of Health (NIH) to collaborate with specified agencies to develop a national cannabis research agenda that must address (1) the therapeutic benefits of cannabis, (2) how it effects specified populations, (3) its long-term effects, (4) clinically appropriate methods to deliver it to the body, and (5)
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MAGIC Act Market Access for Generic Insulin Competition [HB-4244]
To provide for a pathway for chemically synthesized insulin to be approved under an abbreviated new drug application submitted under the Federal Food, Drug, and Cosmetic Act, and for other purposes.
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Competition Prescription Act of 2019 [HB-3947]
To lower the cost of prescription drugs, and for other purposes.