Prescription Drugs
US Congress 116th Congress
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.)
Spread the world
Gettr US Congress 116th Congress
Stop Price Gouging Act [S.378]
Imposes an excise tax on pharmaceutical companies that sell prescription drugs that are subject to price spikes that exceed the annual percentage increase in the Chained Consumer Price Index. For each taxable prescription drug, the excise tax ranges from 50% to 100% of price spike revenue received by the company, depending on the size of the price spike and including an adjustment for revenue that is due solely to an increase in the cost of the inputs necessary to manufacture the drug. Pharmaceutical companies must submit specified data regarding
(continued...)
Spread the world
US Congress 116th Congress
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
(continued...)
Spread the world
US Congress 116th Congress
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.
Spread the world
US Congress 116th Congress
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.
Spread the world
US Congress 116th Congress
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.
Spread the world
US Congress 116th Congress
Right Rebate Act of 2019 [S.205]
Requires drug manufacturers with Medicaid rebate agreements for covered outpatient drugs to disclose drug product information. Manufacturers are subject to civil penalties for knowingly misclassifying drugs. Manufacturers are also required to compensate for rebates that were initially underpaid as a result of misclassification (whether or not such misclassification was committed knowingly).
Spread the world
US Congress 116th Congress
Protect Medicaid Act [S.131]
Prohibits federal payment under Medicaid for the administrative costs of providing health benefits to noncitizens who are ineligible for Medicaid based on their immigration status. The Department of Health and Human Services must report on specified information regarding states that provide health benefits to such individuals.
Spread the world
US Congress 116th Congress
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
(continued...)
Spread the world
US Congress 116th Congress
Medicare Drug Price Negotiation Act [S.99]
Makes a series of changes relating to the prices of prescription drugs under the Medicare prescription drug benefit and Medicare Advantage (MA) prescription drug plans (PDPs). Under current law, the Centers for Medicare & Medicaid Services (CMS) may neither negotiate the prices of covered drugs nor establish a formulary. The bill repeals these restrictions and instead specifically requires the CMS to (1) negotiate the prices of covered drugs; and (2) either establish a formulary for covered drugs, or require changes to PDP formularies that take
(continued...)
Spread the world
US Congress 116th Congress
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.
Spread the world
US Congress 116th Congress
End Taxpayer Subsidies for Drug Ads Act [S.73]
Prohibits tax deductions for expenses relating to direct-to-consumer advertising of prescription drugs. "Direct-to-consumer advertising" is any dissemination, by or on behalf of a sponsor of a prescription drug product, of an advertisement that is (1) in regard to the drug product, and (2) primarily targeted to the general public.
Spread the world
US Congress 116th Congress
Preserve Access to Affordable Generics and Biosimilars Act [S.64]
Authorizes the Federal Trade Commission (FTC) to initiate proceedings against parties to any agreement resolving or settling a patent infringement claim in connection with the sale of a drug or biological product. Such an agreement is presumed to have anticompetitive effects and is a violation of this bill if the filer of the generic drug or biosimilar application receives anything of value and agrees to limit or forego research, development, manufacturing, marketing, or sales of the generic drug or biosimilar. An agreement is exempted if the only
(continued...)
Spread the world
US Congress 116th Congress
Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019 [S.62]
Allows the Centers for Medicare & Medicaid Services to (1) negotiate drug prices under the Medicare prescription drug benefit, and (2) institute a price structure for the reimbursement of drugs covered under the benefit.
Spread the world
US Congress 116th Congress
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
(continued...)
Spread the world
US Congress 116th Congress
Health Savings Act of 2019 [S.12]
Modifies the requirements for health savings accounts (HSAs) to rename high deductible health plans as HSA-qualified health plans; allow spouses who have both attained age 55 to make catch-up contributions to the same HSA; make Medicare Part A (hospital insurance benefits) beneficiaries eligible to participate in an HSA; allow individuals eligible for hospital care or medical services under a program of the Indian Health Service or a tribal organization to participate in an HSA; allow members of a health care sharing ministry to participate in an
(continued...)
Spread the world
US Congress 116th Congress
Keeping Health Insurance Affordable Act of 2019 [S.3]
Alters and establishes several programs relating to health insurance and prescription drugs. Specifically, the bill requires the Department of Health and Human Services (HHS) to establish a public health insurance option through health insurance exchanges. The bill sets forth corresponding implementing provisions, including criteria for payment rates and provider participation. (For example, initial payment rates for providers and services must be set at the same rates as under Medicare; HHS may subsequently alter payment rates in accordance with
(continued...)
Spread the world
US Congress 116th Congress
Expressing the sense of Congress on the need to improve and expand training for future physicians on properly treating pain and prescribing opioids, and for other purposes. [HCR-8]
This concurrent resolution expresses the sense of Congress that medical students and practitioners should receive additional training in pain management and opioid-prescribing practices.
Spread the world
US Congress 116th Congress
Stop Price Gouging Act [HB-1093]
Imposes an excise tax on pharmaceutical companies that sell prescription drugs that are subject to price spikes that exceed the annual percentage increase in the Chained Consumer Price Index. For each taxable prescription drug, the excise tax ranges from 50% to 100% of price spike revenue received by the company, depending on the size of the price spike and including an adjustment for revenue that is due solely to an increase in the cost of the inputs necessary to manufacture the drug. Pharmaceutical companies must submit specified data regarding
(continued...)
Spread the world
US Congress 116th Congress
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...)