Drug Safety, Medical Device, And Laboratory Regulation
US Congress 114th Congress
Gluten in Medicine Disclosure Act of 2015 [HB-3648]
Gluten in Medicine Disclosure Act of 2015 This bill amends the Federal Food, Drug, and Cosmetic Act to prohibit the sale of any drug intended for human use that contains an ingredient other than a polyol that constitutes or is derived from a grain or starch-containing ingredient and whose label does not include a parenthetical statement identifying the source of that ingredient.
Sponsored by: Rep. James McGovern
Referred To The Subcommittee On Health. on 10/02/2015
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Orphan Drug Fairness Act [HB-3618]
Orphan Drug Fairness Act This bill amends the Patient Protection and Affordable Care Act (PPACA) to exclude sales of any drug or biological product approved by the Food and Drug Administration solely for rare diseases or conditions (orphan drug) from the calculation of the annual fee on manufacturers or importers with branded prescription drug sales exceeding $5 million. This Act is effective as if included in PPACA.
Sponsored by: Rep. Leonard Lance
Referred To The Subcommittee On Health. on 10/02/2015
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Reinvigorating Antibiotic and Diagnostic Innovation Act of 2015 [HB-3539]
Reinvigorating Antibiotic and Diagnostic Innovation Act of 2015 This bill amends the Internal Revenue Code to allow tax credits for 50% of the clinical testing expenses for: (1) infectious disease products that are intended to treat a serious or life-threatening infection, including one caused by an antibacterial or antifungal resistant pathogen or a qualifying pathogen listed by the Department of Health and Human Services as having the potential to pose a serious threat to public health; and (2) in-vitro diagnostic devices that identify in less
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Sponsored by: Rep. Raul Grijalva
Introduced In House on 09/17/2015
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Tsunami Warning, Education, and Research Act of 2015 [HB-34]
Tsunami Warning, Education, and Research Act of 2015 Reauthorizes the Tsunami Warning and Education Act through FY2017. (Sec. 4) Consolidates separate tsunami warning systems for the Pacific and Arctic Oceans and for the Atlantic Ocean into a single warning system. Requires the system to support international tsunami forecasting and warning efforts. Requires the National Oceanic and Atmospheric Administration (NOAA) to support or maintain tsunami warning centers to support the national warning system and develop uniform operational procedures for
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Sponsored by: Rep. Suzanne Bonamici
Became Public Law No: 114-255. on 12/13/2016
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Childhood Cancer STAR Act Childhood Cancer Survivorship, Treatment, Access, and Research Act of 2016 [HB-3381]
Childhood Cancer STAR Act Childhood Cancer Survivorship, Treatment, Access, and Research Act of 2016 This bill amends the Public Health Service Act to permit the National Institutes of Health (NIH) to provide support to collect the medical specimens and information of children, adolescents, and young adults with cancer to improve the understanding of these cancers and of the effects of treatment. The national childhood cancer registry is reauthorized through FY2020 and revised to require the Centers for Disease Control and Prevention to award grants
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Sponsored by: Rep. Ted Poe
Received In The Senate. on 12/07/2016
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Foreign Manufacturers Legal Accountability Act of 2015 [HB-3304]
Foreign Manufacturers Legal Accountability Act of 2015 Expresses the sense of Congress with respect to jurisdiction of courts in the United States over foreign manufacturers that import products into the United States. Directs the Food and Drug Administration (FDA) (with respect to drugs, devices, cosmetics, and biological products), the Consumer Product Safety Commission (with respect to consumer products), and the Environmental Protection Agency (with respect to chemical substances, new chemical substances, and pesticides) to require foreign manufacturers
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Sponsored by: Rep. James Langevin
Referred To The Subcommittee On Biotechnology, Horticulture, And Research. on 08/25/2015
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Strengthening Public Health Emergency Response Act of 2016 [HB-3299]
Strengthening Public Health Emergency Response Act of 2016 This bill amends the Public Health Service Act to require the program to enhance community and hospital preparedness for public health emergencies to use at least 97% of its funding for awards. The Government Accountability Office must report on programs for public health emergency preparedness. The Department of Health and Human Services (HHS) must ensure procedures are in place to coordinate the ongoing stockpiling of countermeasures (certain medical supplies) by the Biomedical Advanced
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Sponsored by: Rep. Barbara Comstock
Reported (amended) By The Committee On Energy And Commerce. H. Rept. 114-735. on 09/09/2016
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DXM Abuse Prevention Act of 2015 [HB-3250]
DXM Abuse Prevention Act of 2015 (Sec. 2) This bill amends the Federal Food, Drug, and Cosmetic Act to prohibit the sale of a drug containing dextromethorphan (DXM, a cough suppressant and drug of abuse) to an individual under age 18 unless the individual has a prescription or is actively enrolled in the military. Retailers selling DXM must implement a verification system to ensure compliance. Civil monetary penalties that escalate upon repeated violation are imposed. (Sec. 3) Unfinished DXM may only be possessed by, distributed to, and received
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Sponsored by: Rep. Eleanor Norton
Reported By The Committee On Energy And Commerce. H. Rept. 114-672. on 07/08/2016
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Affordability Is Access Act [HB-3163]
Affordability Is Access Act This bill amends the Public Health Service Act to require health insurance and group health plans to cover, as preventive care for women, over-the-counter oral contraceptives for daily use, regardless of whether an enrollee has a prescription for the contraceptive. (Insurers and plans cannot impose cost sharing for preventive care.)
Sponsored by: Rep. Sean Maloney
Referred To The Subcommittee On Health. on 07/24/2015
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Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2016 [HB-3049]
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2016 Provides FY2016 appropriations to the Department of Agriculture (USDA), the Food and Drug Administration (FDA), and related agencies. TITLE I--AGRICULTURAL PROGRAMS Provides appropriations for the following agricultural programs and services: the Office of the Secretary; Executive Operations; the Office of the Chief Information Officer; the Office of the Chief Financial Officer; the Office of the Assistant Secretary for Civil Rights; the Office
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Sponsored by: Rep. Robert Aderholt
The House Committee On Appropriations Reported An Original Measure, H. Rept. 114-205, By Mr. Aderholt. on 07/14/2015
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Medical Controlled Substances Transportation Act of 2015 [HB-3014]
Medical Controlled Substances Transportation Act of 2015 This bill amends the Controlled Substances Act to allow a physician to transport controlled substances to another practice setting or disaster area if the physician is registered to dispense, or conduct research with, controlled substances listed on schedules II, III, IV, or V, and the physician enters into a specific agreement with the Drug Enforcement Administration (DEA). The agreement must require a physician to provide advance notification to the DEA, limit the duration of transport to
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Sponsored by: Rep. Ted Poe
Committee Consideration And Mark-up Session Held. on 11/18/2015
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Right to Try Act of 2015 [HB-3012]
Right to Try Act of 2015 Bars the federal government from prohibiting or restricting the production, manufacture, distribution, prescribing, dispensing, possession, or use of an experimental drug, biological product, or device that is: (1) intended to treat a patient who has been diagnosed with a terminal illness; and (2) authorized by, and in accordance with, state law. Defines an "experimental drug, biological product, or device" as one that: (1) has successfully completed a phase 1 clinical investigation; (2) remains under investigation in a
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Sponsored by: Rep. Dave Brat
Referred To The Subcommittee On Crime, Terrorism, Homeland Security, And Investigations. on 07/29/2015
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Medical Testing Availability Act of 2015 [HB-298]
Medical Testing Availability Act of 2015 This bill amends the Federal Food, Drug, and Cosmetic Act to prohibit a product labeled for research use only from being deemed adulterated or misbranded on the basis that its manufacturer or distributor: (1) sells the product to an end user who uses the product for a purpose other than research, or (2) engages in business communications with an end user regarding the product.
Sponsored by: Rep. Jackie Speier
Referred To The Subcommittee On Health. on 01/16/2015
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FAST Generics Act of 2015 Fair Access for Safe and Timely Generics Act of 2015 [HB-2841]
FAST Generics Act of 2015 Fair Access for Safe and Timely Generics Act of 2015 This bill amends the Federal Food, Drug, and Cosmetic Act to prohibit the license holder of a Food and Drug Administration (FDA)-approved drug or biological product from restricting availability of the medication for testing by a product developer seeking to develop a drug, generic drug, or biosimilar, including restricting availability with a risk evaluation and mitigation strategy (REMS). Upon request, the license holder of a medication that is not subject to a REMS
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Sponsored by: Rep. Janice Schakowsky
Referred To The Subcommittee On Health. on 06/19/2015
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Antibiotic Development to Advance Patient Treatment Act [HB-2629]
Antibiotic Development to Advance Patient Treatment Act This bill amends the Federal Food, Drug, and Cosmetic Act to allow the Food and Drug Administration (FDA) to agree with the sponsor of an applicable medication on a process for approving the medication for use in a limited population of patients. Applicable medications are antibacterial or antifungal drugs or biological products for the treatment of a serious infection. The FDA may rely on alternate study endpoints, limited data sets, and additional data, including preclinical evidence, in
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Sponsored by: Rep. John Shimkus
Referred To The Subcommittee On Health. on 06/05/2015
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Personal Drug Importation Fairness Act of 2015 [HB-2623]
Personal Drug Importation Fairness Act of 2015 This bill allows a drug to be imported by a person other than the drug's manufacturer if the drug: (1) has the same active ingredients, route of administration, and strength as an approved drug; (2) may be lawfully marketed in, and is imported or reimported from, a country included on a list in this Act that the Food and Drug Administration determines has standards for ensuring drug safety and effectiveness that are at least as protective as U.S. standards; (3) is dispensed by a licensed pharmacist;
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Sponsored by: Rep. Raul Grijalva
Referred To The Subcommittee On Health. on 06/05/2015
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AIM Act of 2015 Accelerating Innovation in Medicine Act of 2015 [HB-2597]
AIM Act of 2015 Accelerating Innovation in Medicine Act of 2015 Amends title XVIII (Medicare) of the Social Security Act to direct the Department of Health and Human Services (HHS) to develop an accelerating innovation in medicine (AIM) list of medical devices for which, because of their inclusion on the list, insurance benefits and payments are prohibited under Medicare (either directly or on a capitated basis), with the result that no Medicare claim may be submitted and an individual who consents to receive such a device is responsible for paying
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Sponsored by: Rep. Ryan Costello
Referred To The Subcommittee On Health. on 06/05/2015
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To amend the HITECH Act with respect to accessing, sharing, and using health data for research purposes. [HB-2549]
To amend the HITECH Act with respect to accessing, sharing, and using health data for research purposes. This bill amends the HITECH Act to require the Department of Health and Human Services (HHS) to revise or clarify the privacy rule established under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) to allow the use and disclosure of protected health information for research purposes without the individual's authorization, approval from an Institutional Review Board or Privacy Board, or representations from the researcher
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Sponsored by: Rep. Cathy McMorris Rodgers
Referred To The Subcommittee On Health. on 05/22/2015
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Surrogate Endpoint Improvement and Utilization Act of 2015 [HB-2547]
Surrogate Endpoint Improvement and Utilization Act of 2015 This bill amends the Federal Food, Drug, and Cosmetic Act to allow the sponsor of a drug that is eligible for accelerated approval to request that the Food and Drug Administration (FDA) agree to an accelerated approval development plan that includes a surrogate endpoint for the study of the drug and a magnitude of drug effect that is sufficient to claim the drug is effective. (Accelerated approval is an FDA process for approving a new drug for a serious medical condition at a point in the
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Sponsored by: Rep. Cathy McMorris Rodgers
Referred To The Subcommittee On Health. on 05/22/2015
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CCM-CARE Act Cerebral Cavernous Malformations Clinical Awareness, Research, and Education Act of 2015 [HB-2480]
CCM-CARE Act Cerebral Cavernous Malformations Clinical Awareness, Research, and Education Act of 2015 This bill amends the Public Health Service Act to require the National Institutes of Health (NIH) to strengthen and coordinate its efforts concerning cerebral cavernous malformation (CCM). (CCM is a condition in which blood vessels in the brain and spinal cord become enlarged, which can lead to seizures, paralysis, hearing or vision loss, or bleeding in the brain.) The NIH may award grants and enter into cooperative agreements for CCM research.
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Sponsored by: Sen. Ben Lujan
Referred To The Subcommittee On Health. on 05/22/2015