Drug Safety, Medical Device, And Laboratory Regulation
US Congress 116th Congress
Medical Innovation Never Stops Act of 2019 [HB-1362]
To amend the Federal Food, Drug, and Cosmetic Act to allow, during a lapse in appropriations, acceptance of certain device submissions and registrations with the corresponding fees made available for obligation and expenditure for the process for the review of device applications, and for other purposes.
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To address the high costs of health care services, prescription drugs, and health insurance coverage in the United States, and for other purposes. [HB-1332]
Addresses the health care system, including Medicare, Medicaid, the private health insurance market, and the prescription drug approval process. The bill also revises tax provisions related to certain health care costs and establishes requirements for lawsuits involving health care provided, at least in part, through a federal program or with federal funds.
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FLAT Prices Act Forcing Limits on Abusive and Tumultuous Prices [HB-1188]
To shorten monopoly periods for prescription drugs that are the subjects of sudden price hikes.
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Protecting Americans from Dangerous Opioids Act [S.419]
Requires the Food and Drug Administration (FDA) to revoke approval for an opioid drug for every new opioid drug approved. (Opioids are drugs with effects similar to opium, such as certain pain medications.) In determining the drug for which to revoke approval, the FDA must prioritize revoking approval for drugs that are not abuse deterrent and consider the public health impact of drugs on the market.
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FDA Accountability for Public Safety Act [S.418]
A bill to establish procedures regarding the approval of opioid drugs by the Food and Drug Administration.
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Changing the Culture of the FDA Act [S.417]
Requires the Food and Drug Administration to amend its mission statement to take responsibility for protecting the public health by considering the danger of addiction and overdose death when approving and regulating prescription opioid medications. (Opioid medications are drugs with effects similar to opium, such as certain pain medications.)
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Blocking Deadly Fentanyl Imports Act [S.400]
Expands reporting requirements related to foreign countries that produce illicit fentanyl and limits assistance to countries that fail to take various actions to combat illegal drug production and trafficking. The President's annual report to Congress on U.S. strategy for controlling international narcotics shall include a section that identifies the countries that are the most significant sources of illicit fentanyl, fentanyl analogues, and precursor chemicals used for producing fentanyl. The report shall also describe the extent to which such
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Medicare Negotiation and Competitive Licensing Act of 2019 [S.377]
Requires the Centers for Medicare & Medicaid Services (CMS) to negotiate with pharmaceutical companies regarding prices for drugs covered under the Medicare prescription drug benefit. (Current law prohibits the CMS from doing so.) The CMS must take certain factors into account during negotiations, including the clinical- and cost-effectiveness of the drug, the financial burden on patients, and unmet patient needs. If the CMS is unable to negotiate the price of a drug, such drug is subject to competitive licensing in order to further its sale under
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FLAT Prices Act Forcing Limits on Abusive and Tumultuous Prices [S.366]
A bill to shorten monopoly periods for prescription drugs that are the subjects of sudden price hikes.
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Hatch-Waxman Integrity Act of 2019 [S.344]
A bill to amend the Federal Food, Drug, and Cosmetic Act and the Securities Exchange Act of 1934 to prevent the inter partes review process for challenging patents from diminishing competition in the pharmaceutical industry and with respect to drug innovation, and for other purposes.
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CREATES Act of 2019 Creating and Restoring Equal Access to Equivalent Samples Act of 2019 [S.340]
A bill to promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products.
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Prescription Drug Price Relief Act of 2019 [S.102]
Establishes a series of oversight and disclosure requirements relating to the prices of brand-name drugs. Specifically, the bill requires the Department of Health and Human Services (HHS) to review at least annually all brand-name drugs for excessive pricing; HHS must also review prices upon petition. If any such drugs are found to be excessively priced, HHS must (1) void any government-granted exclusivity; (2) issue open, nonexclusive licenses for the drugs; and (3) expedite the review of corresponding applications for generic drugs and biosimilar
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Affordable and Safe Prescription Drug Importation Act [S.97]
Addresses the importation of drugs from Canada and other foreign countries. The bill requires the Food and Drug Administration (FDA) to promulgate regulations within 180 days permitting wholesalers, pharmacies, and individuals to import certain prescription drugs from Canada. After two years, The FDA, may permit the importation of prescription drugs from other countries. The bill establishes a process for certifying foreign sellers—a licensed foreign pharmacy or foreign wholesale distributor.
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Safe and Affordable Drugs from Canada Act of 2019 [S.61]
Requires the Food and Drug Administration (FDA) to promulgate regulations within 180 days permitting individuals to import a prescription drug purchased from an approved Canadian pharmacy if the drug is dispensed by a pharmacist licensed in Canada; is purchased for personal use in quantities not greater than a 90-day supply; is filled using a valid prescription issued by a physician licensed to practice in the United States; and has the same active ingredients, route of administration, dosage form, and strength as a prescription drug approved by
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Traditional Cigar Manufacturing and Small Business Jobs Preservation Act of 2019 [S.9]
Exempts traditional large and premium cigars from regulation by the Food and Drug Administration (FDA) and from user fees assessed on tobacco products by the FDA.
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Making consolidated appropriations for the fiscal year ending September 30, 2019, and for other purposes. [HJR-31]
(Sec. 3) This section provides that references to "this Act" included in any division of this bill refer only to the provisions of the division unless the bill expressly provides otherwise. (Sec. 4) This section specifies that the sums in this bill are appropriated for FY2019. (Sec. 5) This section provides that amounts designated by this bill for Overseas Contingency Operations/ Global War on Terrorism pursuant to the Balanced Budget and Emergency Deficit Control Act of 1985 are only available (or rescinded, if applicable) if the President subsequently
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Further Additional Continuing Appropriations Act, 2019 [HJR-28]
(Sec. 101) This joint resolution provides continuing FY2019 appropriations to several federal agencies through the earlier of February 15, 2019, or the enactment of the applicable appropriations legislation. It is known as a continuing resolution (CR) and ends the partial government shutdown that began after the existing CR expired on December 21, 2018, because seven of the remaining FY2019 appropriations bills have not been enacted. (Five of the FY2019 appropriations bills were enacted last year, including the Department of Defense Appropriations
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Blocking Deadly Fentanyl Imports Act [HB-1098]
Expands reporting requirements related to foreign countries that produce illicit fentanyl and limits assistance to countries that fail to take various actions to combat illegal drug production and trafficking. The President's annual report to Congress on U.S. strategy for controlling international narcotics shall include a section that identifies the countries that are the most significant sources of illicit fentanyl, fentanyl analogues, and precursor chemicals used for producing fentanyl. The report shall also describe the extent to which such
(continued...)
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Medicare Negotiation and Competitive Licensing Act of 2019 [HB-1046]
Requires the Centers for Medicare & Medicaid Services (CMS) to negotiate with pharmaceutical companies regarding prices for drugs covered under the Medicare prescription drug benefit. (Current law prohibits the CMS from doing so.) The CMS must take certain factors into account during negotiations, including the clinical- and cost-effectiveness of the drug, the financial burden on patients, and unmet patient needs. If the CMS is unable to negotiate the price of a drug, such drug is subject to competitive licensing in order to further its sale under
(continued...)
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Hatch-Waxman Integrity Act of 2019 [HB-990]
To amend the Federal Food, Drug, and Cosmetic Act and the Securities Exchange Act of 1934 to prevent the inter partes review process for challenging patents from diminishing competition in the pharmaceutical industry and with respect to drug innovation, and for other purposes.