Drug Safety, Medical Device, And Laboratory Regulation
US Congress 114th Congress
To amend the Federal Food, Drug, and Cosmetic Act to provide for the development and use of patient experience data to enhance the structured risk-benefit assessment framework, and for other purposes. [HB-2338]
To amend the Federal Food, Drug, and Cosmetic Act to provide for the development and use of patient experience data to enhance the structured risk-benefit assessment framework, and for other purposes. This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to establish processes under which: (1) an entity seeking to develop patient experience data may submit initial research concepts for feedback; (2) the FDA may request or receive from such an entity draft guidance documents, data, and summaries
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Sponsored by: Rep. Joseph Pitts
Referred To The Subcommittee On Health. on 05/15/2015
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To amend the Federal Food, Drug, and Cosmetic Act to authorize priority review for breakthrough devices. [HB-2337]
To amend the Federal Food, Drug, and Cosmetic Act to authorize priority review for breakthrough devices. This bill amends the Federal Food, Drug, and Cosmetic Act to replace the requirement that the Food and Drug Administration (FDA) prioritize review of breakthrough medical devices with a requirement that the FDA establish a program to provide priority review for breakthrough medical devices. Prior to submitting an application for approval, a medical device sponsor may request that the FDA designate the medical device for priority review. The FDA
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Sponsored by: Rep. Joseph Pitts
Referred To The Subcommittee On Health. on 05/15/2015
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Stop Tampering of Prescription Pills Act of 2015 [HB-2335]
Stop Tampering of Prescription Pills Act of 2015 This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to deny approval to a new oral opioid (a drug with effects similar to opium, such as morphine) that does not have properties that make the drug significantly more difficult to abuse if an abuse-deterrent drug containing the same opioid is available. The FDA may approve an opioid drug that is not abuse-deterrent if approval is necessary to prevent or alleviate a drug shortage or to address a
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Sponsored by: Rep. Janice Schakowsky
Referred To The Subcommittee On Health. on 05/15/2015
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Veterans Information Modernization Act [HB-2256]
Veterans Information Modernization Act (Sec. 2) This bill directs the Department of Veterans Affairs (VA) to report annually to Congress during 2016 through 2020 on its furnishing of hospital care, medical services, and nursing home care. Each report shall: evaluate the effectiveness of the Veterans Health Administration (VHA) program in improving the quality of, and increasing access to, veterans hospital care, medical services, and nursing home care; and assess physician and other VHA employee workloads, patient demographics and utilization rates,
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Sponsored by: Rep. Dan Benishek
Received In The Senate And Read Twice And Referred To The Committee On Veterans' Affairs. on 07/22/2015
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US Congress 114th Congress
Safe and Affordable Drugs from Canada Act of 2015 [HB-2228]
Safe and Affordable Drugs from Canada Act of 2015 Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require the Department of Health and Human Services (HHS) to promulgate regulations within 180 days permitting individuals to import a prescription drug purchased from an approved Canadian pharmacy that: 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
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Sponsored by: Rep. Steve Cohen
Referred To The Subcommittee On Health. on 05/08/2015
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US Congress 114th Congress
Research for All Act of 2015 [HB-2101]
Research for All Act of 2015 This bill directs the Food and Drug Administration (FDA) to ensure that the clinical trials for products granted expedited approval to treat a serious or life-threatening condition are sufficient to determine the safety and effectiveness of the products for men and women using subgroup analysis. This bill amends the Federal Food, Drug, and Cosmetic Act to require the FDA, at the request of the drug sponsor, to facilitate development and expedite review of a new drug that is: intended to avoid serious adverse events or
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Sponsored by: Rep. Janice Schakowsky
Referred To The Subcommittee On Health. on 05/01/2015
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FDA Deeming Authority Clarification Act of 2015 [HB-2058]
FDA Deeming Authority Clarification Act of 2015 This bill amends the Federal Food, Drug, and Cosmetic Act to revise premarket review and reporting requirements for products deemed by the Food and Drug Administration (FDA) to be tobacco products. A product is not subject to premarket review by the FDA if it is introduced to market before that type of product is deemed a tobacco product. A person introducing a tobacco product that is substantially similar to a marketed product less than 21 months after that type of product is deemed a tobacco product
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Sponsored by: Rep. Alexander Mooney
Referred To The Subcommittee On Health. on 05/01/2015
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US Congress 114th Congress
Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015 [HB-1576]
Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015 This bill requires the Government Accountability Office (GAO) to study whether generic versions of certain complex drugs or certain biological drugs face significantly different challenges in meeting the approval standards of the Food and Drug Administration (FDA) than generic versions of small-molecule drugs. (Complex drugs and biological drugs can be composed of large molecules that are more difficult to fully characterize than small molecules, so it can be more difficult
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Sponsored by: Rep. Gus Bilirakis
Referred To The Subcommittee On Health. on 03/27/2015
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Preservation of Antibiotics for Medical Treatment Act of 2015 [HB-1552]
Preservation of Antibiotics for Medical Treatment Act of 2015 This bill amends the Federal Food, Drug, and Cosmetic Act to require an applicant for approval of a new animal drug that is a medically important antimicrobial to demonstrate that there is a reasonable certainty of no harm to human health from antimicrobial resistance attributable to the nontherapeutic use of the drug. Medically important antimicrobials are drugs intended for use in food-producing animals that contain: (1) specified antibiotics, or (2) certain drugs on the World Health
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Sponsored by: Rep. Raul Grijalva
Referred To The Subcommittee On Health. on 03/27/2015
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Advancing Hope Act of 2015 [HB-1537]
Advancing Hope Act of 2015 This bill amends the Federal Food, Drug, and Cosmetic Act to expand the priority review voucher program for rare pediatric diseases to include treatments for sickle cell disease and pediatric cancers. The voucher program is extended by removing the provision terminating the program one year after the Food and Drug Administration's (FDA's) issuance of three rare pediatric disease vouchers. A voucher may not be issued for a rare pediatric disease product if a voucher was issued for the product as a tropical disease product.
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Sponsored by: Rep. Tony Cardenas
Referred To The Subcommittee On Health. on 03/27/2015
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Ensuring Access to Quality Complex Rehabilitation Technology Act of 2015 [HB-1516]
Ensuring Access to Quality Complex Rehabilitation Technology Act of 2015 Amends title XVIII (Medicare) of the Social Security Act to cover, as medical and other health services, complex rehabilitation technology (CRT) items designed or individually configured for a specific qualified individual to meet that individual's unique: (1) medical, physical, or functional needs related to a medical condition; and (2) capacities for basic activities of daily living (ADLs) or instrumental ADLs. Directs the Secretary of Health and Human Services to: (1) designate
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Sponsored by: Rep. Sean Maloney
Referred To The Subcommittee On Health. on 04/01/2015
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Drug Free Commercial Driver Act of 2015 [HB-1467]
Drug Free Commercial Driver Act of 2015 Revises regulations that require motor carriers to conduct preemployment, reasonable suspicion, random, and post-accident testing of commercial motor vehicle operators for controlled substances or alcohol. Allows motor carriers to use hair testing as an acceptable alternative to urinalysis for detecting use of controlled substances by an operator, but only for preemployment testing and random testing (but the latter only if the motor carrier tested the operator at preemployment using the same method). Requires
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Sponsored by: Rep. Eleanor Norton
Referred To The Subcommittee On Highways And Transit. on 03/20/2015
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Speeding Access to Already Approved Pharmaceuticals Act of 2015 [HB-1455]
Speeding Access to Already Approved Pharmaceuticals Act of 2015 This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration to facilitate the development and expedite the review of a new drug, biological product, or device that has been approved in the European Union.
Sponsored by: Rep. Tim Ryan
Referred To The Subcommittee On Health. on 03/20/2015
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Infection Reduction Labeling Act [HB-1424]
Infection Reduction Labeling Act This bill amends the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to authorize solid antimicrobial copper alloys, and products made from such alloys, to be marketed, distributed, or sold with labels about their infection reduction and control efficacy if the antimicrobial claims made on the label are consistent with the results of federally-funded clinical trials finding: (1) greater than 25% reductions in infection rate or 50% reductions in microbial burden, or (2) statistically significant reductions
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Sponsored by: Rep. Elizabeth Esty
Referred To The Subcommittee On Biotechnology, Horticulture, And Research. on 04/08/2015
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Patient Choice Act of 2015 [HB-1376]
Patient Choice Act of 2015 Amends the Federal Food, Drug, and Cosmetic Act to authorize provisional approval of fast track products determined by the Department of Health and Human Services (HHS) to be adequately safe. Treats provisional approval in the same manner as approval of a drug, except that provisional approval is subject to requirements related to informed consent and continued pursuit of safety and efficacy data for purposes of gaining approval for the drug. Defines the term “adequately safe” to mean that: (1) for at least one population,
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Sponsored by: Rep. H. Morgan Griffith
Referred To The Subcommittee On Health. on 03/20/2015
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PATIENT Act of 2015 Promoting Access for Treatments Ideal in Enhancing New Therapies Act of 2015 [HB-1353]
PATIENT Act of 2015 Promoting Access for Treatments Ideal in Enhancing New Therapies Act of 2015 This bill amends the Federal Food, Drug, and Cosmetic Act to extend to five years the three-year marketing exclusivity period provided to certain new drugs that include an active ingredient that was already approved by the Food and Drug Administration. A drug is provided this extended exclusivity period if it is approved for a new indication or use, or the drug has been reformulated or redesigned to: promote greater patient adherence to an approved treatment
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Sponsored by: Rep. Gerald Connolly
Referred To The Subcommittee On Health. on 03/20/2015
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Microbead-Free Waters Act of 2015 [HB-1321]
Microbead-Free Waters Act of 2015 (Sec. 2) This bill amends the Federal Food, Drug, and Cosmetic Act to ban rinse-off cosmetics that contain intentionally-added plastic microbeads beginning on January 1, 2018, and to ban manufacturing of these cosmetics beginning on July 1, 2017. These bans are delayed by one year for cosmetics that are over-the-counter drugs.
Sponsored by: Rep. Raul Grijalva
Became Public Law No: 114-114. (txt | Pdf) on 12/28/2015
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Clinical Trials Modernization Act of 2015 [HB-1066]
Clinical Trials Modernization Act of 2015 This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to allow sponsors of applications for new drugs, biological products, and medical devices to propose incorporation of alternative statistical methods, including adaptive trial design and Bayesian methods, into clinical trial protocols and marketing applications. The FDA is required to issue guidance that establishes or clarifies standards for using alternative statistical methods in clinical trials.
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Sponsored by: Rep. Chris Collins
Referred To The Subcommittee On Health. on 02/27/2015
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Biological Implant Tracking and Veteran Safety Act of 2015 [HB-1016]
Biological Implant Tracking and Veteran Safety Act of 2015 Directs the Department of Veterans Affairs (VA) to: (1) adopt the unique device identification system developed for medical devices by the Food and Drug Administration (FDA), or implement a comparable standard identification system, for identifying biological implants intended for use in medical procedures conducted in VA medical facilities; (2) permit a vendor to use any of the accredited entities identified by the FDA as an issuing agency in adopting or implementing such a system; (3)
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Sponsored by: Rep. David Roe
Subcommittee Consideration And Mark-up Session Held. on 04/21/2015
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US Congress 116th Congress
A resolution expressing the sense of the Senate on the need for common sense solutions to improve health care delivery and affordability for all people of the United States. [SR-777]
This resolution expresses support for access to health insurance coverage that protects individuals with preexisting conditions, reduces the cost of prescription drugs and monthly premiums, protects individuals from surprise medical bills, and deters medical practices intended to reduce the risk of malpractice claims.
Sponsored by: Sen. David Perdue
Referred To The Committee On Health, Education, Labor, And Pensions. on 11/18/2020