Drug Safety, Medical Device, And Laboratory Regulation
US Congress 116th Congress
Gluten in Medicine Disclosure Act of 2019 [S.3021]
A bill 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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International Pharmaceutical Transparency Act of 2019 [HB-5381]
To amend the Federal Food, Drug, and Cosmetic Act to require the label of a drug to list the country of origin of each of the drug's active ingredients.
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Lower Costs, More Cures Act of 2019 [HB-19]
Establishes and modifies several requirements to address prescription drug prices under Medicare, Medicaid, and other programs. The bill generally limits payment amounts for drugs and biologics under Medicare medical services, reduces cost-sharing under the Medicare prescription drug benefit, modifies certain authorities and requirements under the Medicaid Drug Rebate Program, revises provisions relating to regulatory approval and commercial availability of generics and biosimilars, and establishes several reporting requirements for drug manufacturers
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Ensuring Patient Access to Critical Breakthrough Products Act of 2019 [HB-5333]
Provides for Medicare coverage of medical devices that are approved under the Food and Drug Administration (FDA) Breakthrough Devices Program. (Under the program, manufacturers work with the FDA to expedite the review and approval of certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human diseases or conditions.) The bill allows designated medical breakthrough devices to be temporarily covered under Medicare during a three-year transitional period. The Centers for Medicare
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Cosmetic Safety Enhancement Act of 2019 [HB-5279]
To amend the Federal Food, Drug, and Cosmetic Act to improve cosmetic safety, and for other purposes.
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Insulin Price Reduction Act [S.2199]
Prohibits health insurance plan issuers and pharmacy benefits managers (PBMs) from receiving rebates or discounts for insulin from manufacturers who certify that its current insulin list price has been reduced to an amount no greater than what the list price was for the same insulin on July 1, 2006. This restriction does not apply to discounts provided to insurance plan holders at retail sale or to flat-rate fees for service paid to PBMs. Further, insurance plans are prohibited from applying a deductible to insulin that has received such price certification.
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Quality Care for Nursing Home Residents Act of 2019 [S.2943]
Establishes several requirements for Medicare skilled nursing facilities and Medicaid nursing facilities with respect to minimum staffing levels, training for nurses, and protections for whistleblowers and residents. The bill also requires specific consent procedures in relation to the administration of certain psychotropic drugs and prohibits the use of pre-dispute arbitration agreements in such facilities.
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Quality Care for Nursing Home Residents Act of 2019 [HB-5216]
Establishes several requirements for Medicare skilled nursing facilities and Medicaid nursing facilities with respect to minimum staffing levels, training for nurses, and protections for whistleblowers and residents. The bill also requires specific consent procedures in relation to the administration of certain psychotropic drugs and prohibits the use of pre-dispute arbitration agreements in such facilities.
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Patients’ Right to Know Their Medication Act of 2019 [HB-5198]
To amend the Federal Food, Drug, and Cosmetic Act regarding the patient medication information required to be included in the labeling of prescription drugs, and for other purposes.
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SARMs Control Act of 2019 Selective Androgen Receptor Modulators Control Act of 2019 [S.2895]
A bill to amend the Controlled Substances Act to more effectively regulate selective androgen receptor modulators, and for other purposes.
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Improving Medicare Beneficiary Access to Innovative Diabetes Technologies Act of 2019 [S.2901]
Establishes the Task Force on Innovative Diabetes Technologies and Services to address the accessibility of innovative diabetes technologies and services to Medicare beneficiaries. The bill defines innovative diabetes technologies and services as medical technologies and services for diabetes treatment that are not covered under Medicare. Among other activities, the task force must (1) recommend ways to improve access to innovative diabetes technologies and services through new or alternative payment models and existing policies, and (2) propose
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Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 [HB-5133]
Prohibits, subject to certain exceptions, the practice of product hopping, which is presumed when a drug manufacturer obtains removal of a drug from the Food and Drug Administration's approved drug list, discontinues a drug, or markets a reformulation of an already approved drug during a certain period after which the manufacturer has been notified that a competing drug manufacturer has applied for generic drug approval.
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Medical Innovation Act of 2019 [HB-5031]
Requires certain drug manufacturers to make payments to fund research supported by the Food and Drug Administration (FDA) and the National Institutes of Health (NIH). A drug manufacturer with over $1 billion in net income in a fiscal year that has entered into a relevant settlement agreement regarding specified violations must pay 0.75%-1.5% of its net income to the Department of Health and Human Services for each of its covered blockbuster drugs. A covered blockbuster drug is a drug that has at least $1 billion in net sales in a year and was developed,
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MATE Act of 2019 Medication Access and Training Expansion Act of 2019 [HB-4974]
Requires prescribers of controlled substances, as a condition of obtaining or renewing their registration with the Drug Enforcement Administration, to complete specified education or training on the prevention, treatment, and management of opioid-use and other substance-use disorders. This education and training shall also satisfy the training requirements currently needed to obtain waivers to prescribe certain medication-assisted treatments for opioid-use disorders in settings other than opioid treatment programs.
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Protecting Access to Safe and Effective Medicines Act of 2019 [HB-4955]
To amend the Federal Food, Drug, and Cosmetic Act to clarify the meaning of a new chemical entity.
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Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019 [S.2740]
A bill to amend the Federal Food, Drug, and Cosmetic Act to clarify the regulatory framework with respect to certain nonprescription drugs that are marketed without an approved new drug application, and for other purposes.
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Patient Access to ESRD New Innovative Devices Act [S.2751]
Requires the Centers for Medicare & Medicaid Services (CMS) to establish a process to provide a certain payment adjustment under the Medicare end-stage renal disease (ESRD) prospective payment system. Specifically, the CMS must establish a process to provide for a temporary add-on payment adjustment for new medical devices used to diagnose, treat, or manage ESRD.
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Mitigating Emergency Drug Shortages Act [S.2723]
A bill to amend the Federal Food, Drug, and Cosmetic Act to reduce drug storages, and for other purposes.
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Insulin Price Reduction Act [HB-4906]
Prohibits health insurance plan issuers and pharmacy benefits managers (PBMs) from receiving rebates or discounts for insulin from manufacturers who certify that its current insulin list price has been reduced to an amount no greater than what the list price was for the same insulin on July 1, 2006. This restriction does not apply to discounts provided to insurance plan holders at retail sale or to flat-rate fees for service paid to PBMs. Further, insurance plans are prohibited from applying a deductible to insulin that has received such price certification.
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National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2020 [HB-4866]
To amend the 21st Century Cures Act to provide for designation of institutions of higher education that provide research, data, and leadership on continuous manufacturing as National Centers of Excellence in Continuous Pharmaceutical Manufacturing, and for other purposes.