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Changing the Culture of the FDA ActThis bill 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.)

Safe Drugs Act This bill authorizes the Food and Drug Administration (FDA) to order the mandatory recall of any drug when the FDA determines that there is a reasonable probability that the drug would cause serious adverse health consequences or death. Currently, the FDA may order a mandatory recall under such circumstances only with respect to a controlled substance.

Adding Epidemic Diseases to the FDA Priority Review Voucher Program Act This bill 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.

Prescription Freedom Act of 2020 This bill generally eliminates the authority of the Food and Drug Administration (FDA) to require that a drug be dispensed only with a prescription. However, the FDA may continue to require a prescription for any drug intended for terminating a pregnancy.

Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2021 This bill provides FY2021 appropriations for the Department of Agriculture (USDA), the Food and Drug Administration, and related agencies. The bill provides appropriations to USDA for Agricultural Programs, including * the Office of the Secretary, * Executive Operations, * the Economic Research Service, * the National Agricultural Statistics Service, * the Agricultural Research Service, * the National Institute of Food and Agriculture, * the Animal and Plant Health Inspection Service, * the Agricultural Marketing Service, and * the Food Safety and Inspection Service. The bill also provides appropriations to USDA for Farm Production and Conservation Programs, including * the Farm Production and Conservation Business Center, * the Farm Service Agency, * the Risk Management Agency, and * the Natural Resources Conservation Service. The bill provides appropriations to the Federal Crop Insurance Corporation Fund and the Commodity Credit Corporation Fund. For USDA Rural Development programs, the bill includes appropriations for * Rural Development Salaries and Expenses, * the Rural Housing Service, * the Rural Business-Cooperative Service, and * the Rural Utilities Service. The bill provides appropriations to the Food and Nutrition Service for * Child Nutrition Programs; * the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC); * the Supplemental Nutrition Assistance Program (SNAP, formerly known as the food stamp program); * the Commodity Assistance Program; and * Nutrition Programs Administration. The bill provides appropriations to the Foreign Agricultural Service for (1) Food for Peace Title II Grants, and (2) McGovern-Dole International Food for Education and Child Nutrition Program Grants. The bill also provides appropriations for * the Food and Drug Administration, * the Commodity Futures Trading Commission, and * the Farm Credit Administration. Additionally, the bill sets forth requirements and restrictions for using funds provided by this and other appropriations Acts.

Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2020 This bill provides FY2020 appropriations for the Department of Agriculture (USDA), the Food and Drug Administration, and Related Agencies. The bill provides appropriations to USDA for Agricultural Programs, including * the Office of the Secretary, * Executive Operations, * the Office of the Chief Information Officer, * the Office of the Chief Financial Officer, * the Office of Civil Rights, * Agriculture Buildings and Facilities, * Hazardous Materials Management, * the Office of Inspector General, * the Office of the General Counsel, * the Office of Ethics, * the Economic Research Service, * the National Agricultural Statistics Service, * the Agricultural Research Service, * the National Institute of Food and Agriculture, * the Animal and Plant Health Inspection Service, * the Agricultural Marketing Service, and * the Food Safety and Inspection Service. The bill also provides appropriations to USDA for Farm Production and Conservation Programs, including * the Farm Production and Conservation Business Center, * the Farm Service Agency, * the Risk Management Agency, and * the Natural Resources Conservation Service. The bill provides appropriations to the Federal Crop Insurance Corporation Fund and the Commodity Credit Corporation Fund. For USDA Rural Development programs, the bill includes appropriations for * Rural Development Salaries and Expenses, * the Rural Housing Service, * the Rural Business-Cooperative Service, and * the Rural Utilities Service. Within the Food and Nutrition Service budget, the bill includes appropriations for * Child Nutrition Programs; * the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC); * the Supplemental Nutrition Assistance Program (SNAP, formerly known as the food stamp program); * the Commodity Assistance Program; and * Nutrition Programs Administration. Within the Foreign Agricultural Service budget, the bill provides appropriations for Food for Peace Title II Grants and McGovern-Dole International Food for Education and Child Nutrition Program Grants. The bill also provides appropriations for the Food and Drug Administration and the Farm Credit Administration. Additionally, the bill sets forth requirements and restrictions for using funds provided by this and other appropriations Acts.

Pharmaceutical Accountability, Responsibility, and Transparency Act or the PART Act This bill expands requirements for manufacturers of certain drugs and medical devices to report information to the Food and Drug Administration (FDA) and contains related provisions. A manufacturer of a life-saving drug or medical device must notify the FDA of certain issues that may affect the drug or device's availability, such as an increase in demand that the manufacturer is likely unable to meet or an export restriction imposed by a foreign country where the drug or device is being manufactured. The manufacturer must notify the FDA within five days of becoming aware of the issue. The bill also expands the types of foreign manufacturers of drugs and medical devices that must register with the FDA. Additionally, the bill expands a requirement for registered manufacturers to submit periodic reports to the FDA by (1) increasing the frequency of such reports, and (2) requiring the reports to include additional information about the amounts of drugs and medical devices being manufactured.

This bill expands existing requirements relating to supply shortages of life-saving drugs to also apply to life-saving medical devices. Generally, a manufacturer must (1) notify the Food and Drug Administration (FDA) of supply interruptions in certain circumstances, (2) provide for the expedited review of a new device that may mitigate the shortage, and (3) allow the FDA to authorize the importation of the device for emergency medical care.

Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2020 This bill provides FY2020 appropriations for the Department of Agriculture (USDA), the Food and Drug Administration, and Related Agencies. The bill provides appropriations to USDA for Agricultural Programs, including * the Office of the Secretary, * Executive Operations, * the Office of the Chief Information Officer, * the Office of the Chief Financial Officer, * the Office of Civil Rights, * Agriculture Buildings and Facilities, * Hazardous Materials Management, * the Office of Inspector General, * the Office of the General Counsel, * the Office of Ethics, * the Economic Research Service, * the National Agricultural Statistics Service, * the Agricultural Research Service, * the National Institute of Food and Agriculture, * the Animal and Plant Health Inspection Service, * the Agricultural Marketing Service, and * the Food Safety and Inspection Service. The bill also provides appropriations to USDA for Farm Production and Conservation Programs, including * the Farm Production and Conservation Business Center, * the Farm Service Agency, * the Risk Management Agency, and * the Natural Resources Conservation Service. The bill provides appropriations to the Federal Crop Insurance Corporation Fund and the Commodity Credit Corporation Fund. For USDA Rural Development programs, the bill includes appropriations for * Rural Development Salaries and Expenses, * the Rural Housing Service, * the Rural Business-Cooperative Service, and * the Rural Utilities Service. Within the Food and Nutrition Service budget, the bill includes appropriations for * Child Nutrition Programs; * the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC); * the Supplemental Nutrition Assistance Program (SNAP, formerly known as the food stamp program); * the Commodity Assistance Program; and * Nutrition Programs Administration. Within the Foreign Agricultural Service budget, the bill provides appropriations for Food for Peace Title II Grants and McGovern-Dole International Food for Education and Child Nutrition Program Grants. The bill also provides appropriations for * the Food and Drug Administration, * the Commodity Futures Trading Commission, and * the Farm Credit Administration. Additionally, the bill sets forth requirements and restrictions for using funds provided by this and other appropriations Acts.

Expanded Food Safety Investigation Act of 2019 This bill provides that the Food and Drug Administration (FDA) may, under specified circumstances, request access to a concentrated animal-feeding operation (i.e., a stabled or confined animal-feeding operation) to conduct microbial sampling. Specifically, the bill allows the FDA to request access if the FDA determines that sampling is necessary to facilitate an investigation of a foodborne-illness outbreak, determine the cause of the outbreak, or address other public health needs. The bill provides that such an operation shall be subject to penalties for refusing such a sampling.

Preventing Drug Shortages Act This bill expands existing manufacturer reporting requirements related to shortages of life-saving drugs and contains other related provisions. The bill requires a manufacturer of an active pharmaceutical ingredient of a life-saving drug to notify the Food and Drug Administration (FDA) of an interruption that is likely to lead to a meaningful disruption in the ingredient's supply, whereas under current law this requirement generally applies only to the manufacturer of a life-saving drug that faces a supply disruption. The notification must contain specified information, including any alternative sources for the ingredient. The bill also requires a manufacturer of a life-saving drug or an active pharmaceutical ingredient for such a drug to include in its annual product registration the specific facilities where the drug or ingredient is manufactured. The FDA may also require the manufacturer to conduct periodic risk assessments to address vulnerabilities in its supply chain. The Government Accountability Office shall report to Congress on the FDA's intra-agency coordination in assessing drug shortage risks.

Safe and Affordable Drugs from Canada Act of 2019 This bill 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 the FDA. Under the bill, certain drugs may not be imported, including controlled substances and biological products. The bill establishes a certification process for approving Canadian pharmacies. The FDA must publish a list of approved Canadian pharmacies.

Safe and Affordable Drugs from Canada Act of 2019 This bill 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 the FDA. Under the bill, certain drugs may not be imported, including controlled substances and biological products. The bill establishes a certification process for approving Canadian pharmacies. The FDA must publish a list of approved Canadian pharmacies.

Affordable and Safe Prescription Drug Importation Act This bill 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.

Affordable and Safe Prescription Drug Importation Act This bill 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.

Medical Innovation Act of 2020 This bill 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, in whole or in part, through federal investments in medical research. Payments are divided between the FDA and the NIH in proportion to the discretionary funding of those agencies, excluding FDA user fees. Payments are not disbursed if appropriations for the FDA or the NIH are lower than in the prior fiscal year. Priorities for payments must include advancing regulatory science for medical products and research related to diseases that disproportionately account for federal health care spending. A covered blockbuster drug for which a manufacturer has not made a required payment is considered misbranded and subject to prohibitions on introducing or receiving misbranded drugs in interstate commerce.

Medical Innovation Act of 2019 This bill 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, in whole or in part, through federal investments in medical research. Payments are divided between the FDA and the NIH in proportion to the discretionary funding of those agencies, excluding FDA user fees. Payments are not disbursed if appropriations for the FDA or the NIH are lower than in the prior fiscal year. Priorities for payments must include advancing regulatory science for medical products and research related to diseases that disproportionately account for federal health care spending. A covered blockbuster drug for which a manufacturer has not made a required payment is considered misbranded and subject to prohibitions on introducing or receiving misbranded drugs in interstate commerce.

Food Safety Modernization for Innovative Technologies Act This bill provides statutory authority for joint agency jurisdiction over food intended for humans that is produced using animal cell culture technology. The Food and Drug Administration (FDA) shall oversee tissue collection, cell lines, and cell banks. The FDA shall regulate food derived from cell lines of animals other than livestock or poultry, and the Department of Agriculture shall regulate food derived from cell lines of livestock and poultry.

Food Safety Modernization for Innovative Technologies Act This bill provides statutory authority for joint agency jurisdiction over food intended for humans that is produced using animal cell culture technology. The Food and Drug Administration (FDA) shall oversee tissue collection, cell lines, and cell banks. The FDA shall regulate food derived from cell lines of animals other than livestock or poultry, and the Department of Agriculture shall regulate food derived from cell lines of livestock and poultry.

Affordability is Access Act This bill establishes several requirements relating to health-insurance coverage of, and access to, over-the-counter contraceptives. Specifically, the bill requires the Department of Health and Human Services, the Department of Labor, and the Department of the Treasury to specify that private health-insurance plans must cover over-the-counter contraceptives that are approved by the Food and Drug Administration (FDA), even without a prescription. Under current law, private health-insurance plans (with some exceptions) must cover FDA-approved prescription contraceptives, without cost-sharing requirements. The bill also prohibits retailers from interfering with an individual's access to oral contraceptives that are meant for routine, daily use and are FDA-approved for use without a prescription.

Affordability is Access Act This bill establishes several requirements relating to health-insurance coverage of, and access to, over-the-counter contraceptives. Specifically, the bill requires the Department of Health and Human Services, the Department of Labor, and the Department of the Treasury to specify that private health-insurance plans must cover over-the-counter contraceptives that are approved by the Food and Drug Administration (FDA), even without a prescription. Under current law, private health-insurance plans (with some exceptions) must cover FDA-approved prescription contraceptives, without cost-sharing requirements. The bill also prohibits retailers from interfering with an individual's access to oral contraceptives that are meant for routine, daily use and are FDA-approved for use without a prescription.

Accelerating Access to Critical Therapies for ALS Act This bill establishes a grant program, as well as a new center within the Food and Drug Administration (FDA), to facilitate access to investigational therapies for neurodegenerative diseases such as amyotrophic lateral sclerosis (i.e., ALS, also known as Lou Gehrig's disease, a progressive and fatal disease). Specifically, the Department of Health and Human Services (HHS) must award grants for the provision of investigational drugs for ALS and other rapidly progressing neurodegenerative diseases through an expanded access (i.e., compassionate use) program. HHS may award these grants to (1) a small business that is the sponsor of an investigational new drug application, or (2) a participating clinical trial site for such a sponsor. Additionally, HHS must establish within the FDA a Center of Excellence for Neurodegenerative Diseases. The center shall have duties and authorities similar to those of the FDA's Oncology Center of Excellence, which helps expedite the development of medical products and assists providers in requesting access to investigational drugs.

Promising Pathway Act This bill establishes a provisional approval pathway for medicines intended for serious or life-threatening diseases, including illnesses posing a threat of epidemic or pandemic. The period of the provisional approval is for two years and is potentially renewable. The Food and Drug Administration (FDA) must establish a priority review system to evaluate completed provisional approval applications within 90 days of receipt. A provisional approval application may be approved if the FDA determines that (1) there is substantial evidence of safety for the drug; and (2) there is relevant early evidence of efficacy, based on adequate and well-controlled investigations. During the COVID-19 (i.e., coronavirus disease 2019) pandemic, or another epidemic or pandemic, the FDA must accept and review various portions of a provisional approval application on a rolling basis. The manufacturer of a provisionally approved drug must require patients to participate in an observational registry. A manufacturer that fails to comply with registry requirements is subject to civil penalties. A provisionally approved drug must be labeled as such. If a drug that receives provisional approval status is not brought to market within 180 days of the approval, the approval must be rescinded. The bill also limits the liability of a manufacturer of a provisionally approved drug with respect to any claim under state law alleging that the drug is unsafe or ineffective. Private health insurers and federal health care programs shall not deny coverage of a provisionally approved drug on the basis of it being experimental.