Drug Safety, Medical Device, And Laboratory Regulation
US Congress 114th Congress
Promoting Life-Saving New Therapies for Neonates Act of 2016 [HB-5182]
Promoting Life-Saving New Therapies for Neonates Act of 2016 This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to award the sponsor of a new drug or biological product for the treatment of newborns a neonatal drug exclusivity voucher upon approval of the medication. A neonatal drug exclusivity voucher is a transferable voucher for a one-year extension of all existing patents and marketing exclusivities for a brand name medication. For a sponsor to be eligible for a voucher, the new medication
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Sponsored by: Rep. Alexander Mooney
Referred To The Subcommittee On Health. on 05/13/2016
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VFD Repeal Act of 2016 [HB-5140]
VFD Repeal Act of 2016 This bill repeals the Food and Drug Administration's (FDA's) final rule regarding the Veterinary Feed Directive published on June 3, 2015, and prohibits the FDA from issuing any similar rule. (Veterinary Feed Directive regulations prohibit the use of medically important antibiotics for animal production purposes. Under these regulations, an animal producer may only use such antibiotics with the authorization of a veterinarian for the prevention, control, or treatment of a specifically identified disease. The rule repealed
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Sponsored by: Sen. Markwayne Mullin
Referred To The Subcommittee On Health. on 05/06/2016
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Over-The-Counter Contraceptives Act of 2016 [HB-5138]
Over-The-Counter Contraceptives Act of 2016 This bill requires the Food and Drug Administration (FDA) to prioritize review of supplemental drug applications (applications to modify the approved use of a drug) for contraceptive drugs intended for routine use that would be available to individuals aged 18 and older without a prescription. The FDA must waive user fees for such supplemental drug applications. Any drug that is eligible for this priority review must be a prescription drug for individuals under age 18. This bill repeals provisions of the
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Sponsored by: Rep. Barbara Comstock
Referred To The Subcommittee On Health. on 05/12/2016
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Curb Opioid Misuse By Advancing Technology Act of 2016 [HB-5127]
Curb Opioid Misuse By Advancing Technology Act of 2016
Sponsored by: Rep. Gerald Connolly
Referred To The Subcommittee On Health. on 05/06/2016
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DISARM Act of 2015 Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2015 [HB-512]
DISARM Act of 2015 Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2015 Amends title XVIII (Medicare) of the Social Security Act to direct the Secretary of Health and Human Services to: (1) recognize the costs of DISARM antimicrobial drugs under the Medicare payment system for the inpatient services of subsection (d) hospitals, (2) provide for additional payment with respect to discharges involving such drugs, (3) publish in the Federal Register a list of the DISARM antimicrobial drugs, and (4) make a proportional
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Sponsored by: Rep. Ted Lieu
Referred To The Subcommittee On Health. on 02/05/2015
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Ensuring Patient Access to Critical Breakthrough Products Act of 2016 [HB-5009]
Ensuring Patient Access to Critical Breakthrough Products Act of 2016 This bill amends titles XVIII (Medicare) and XIX (Medicaid) of the Social Security Act to modify provisions related to coverage and payment for certain breakthrough medical devices under the Medicare and Medicaid programs. Specifically, with respect to such devices, the bill: (1) provides for transitional coverage; (2) establishes accelerated processes for determining regular coverage and payment; and (3) modifies provisions related to specified payment adjustments, cost thresholds,
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Sponsored by: Rep. Tony Cardenas
Referred To The Subcommittee On Health. on 05/05/2016
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Opioid Review Modernization Act of 2016 [HB-4976]
Opioid Review Modernization Act of 2016 (Sec. 2) This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to refer new drug applications for opioids (drugs with effects similar to opium, such as certain pain medications) to an advisory committee before approval, unless the FDA finds that such a referral is scientifically unnecessary and not in the interest of protecting and promoting public health and the FDA notifies Congress of its rationale. The FDA must convene an advisory committee on labeling
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Sponsored by: Rep. Sean Maloney
Received In The Senate And Read Twice And Referred To The Committee On Health, Education, Labor, And Pensions. on 05/12/2016
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Preventing Superbugs and Protecting Patients Act [HB-4966]
Preventing Superbugs and Protecting Patients Act This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to identify types of medical devices for which premarket notification must include proposed labeling, including validated instructions regarding cleaning, disinfection, and sterilization. The FDA must issue final guidance regarding when a premarket notification is required for a modification to a medical device.
Sponsored by: Rep. Ted Lieu
Referred To The Subcommittee On Health. on 04/22/2016
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Disclosure; and Encouragement of Verification, Innovation, Cleaning, and Efficiency Act of 2016 [HB-4965]
Disclosure; and Encouragement of Verification, Innovation, Cleaning, and Efficiency Act of 2016
Sponsored by: Rep. Ted Lieu
Referred To The Subcommittee On Health. on 04/22/2016
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Lower Drug Costs through Competition Act [HB-4784]
Lower Drug Costs through Competition Act This bill amends the Federal Food, Drug, and Cosmetic Act to revise provisions regarding review and approval of generic drug applications or supplements to generic drug applications for drugs: (1) for which there is a shortage, or (2) that have not been recently introduced to the market by more than one manufacturer and for which tentative approval has not been granted to more than two applications. The Food and Drug Administration (FDA) must prioritize the review of such submissions and act on them within
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Sponsored by: Rep. Barbara Lee
Referred To The Subcommittee On Health. on 03/18/2016
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REGROW Act Reliable and Effective Growth for Regenerative Health Options that Improve Wellness [HB-4762]
REGROW Act Reliable and Effective Growth for Regenerative Health Options that Improve Wellness This bill amends the Public Health Service Act to require the Food and Drug Administration (FDA) to conditionally approve certain cellular therapeutic products without initiation of large-scale clinical trials. A conditionally approved cellular therapy may be marketed if certain conditions are met, including conditions on the source, processing, and function of the cells in the product.
Sponsored by: Rep. H. Morgan Griffith
Referred To The Subcommittee On Health. on 03/18/2016
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Advancing Standards in Regenerative Medicine Act [HB-4669]
Advancing Standards in Regenerative Medicine Act This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to facilitate the establishment of a public-private Standards Coordinating Body in Regenerative Medicine and Advanced Therapies. The FDA must work with this body to develop standards to support the development and review of regenerative medicine products.
Sponsored by: Rep. Tim Ryan
Referred To The Subcommittee On Health. on 03/04/2016
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Responsibility in Drug Advertising Act of 2016 [HB-4565]
Responsibility in Drug Advertising Act of 2016 This bill amends the Federal Food, Drug, and Cosmetic Act to prohibit direct-to-consumer advertising of a drug in the first three years after the drug's approval. The Food and Drug Administration may: (1) waive the third year of this prohibition for a drug if direct-to-consumer advertising of the drug would have an affirmative value to public health, or (2) extend the prohibition if the drug has significant adverse health effects.
Sponsored by: Rep. Rosa DeLauro
Referred To The Subcommittee On Health. on 02/19/2016
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Adding Zika Virus to the FDA Priority Review Voucher Program Act [HB-4400]
Adding Zika Virus to the FDA Priority Review Voucher Program Act This bill amends the Federal Food, Drug, and Cosmetic Act to add the Zika virus to the list of tropical diseases under the priority review voucher program, which awards a voucher to the sponsor of a new drug or biological product that is approved to prevent or treat a tropical disease. (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.)
Sponsored by: Rep. Barbara Lee
Referred To The Subcommittee On Health. on 02/05/2016
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Cosmetic Modernization Amendments of 2015 [HB-4075]
Cosmetic Modernization Amendments of 2015 This bill amends the Federal Food, Drug, and Cosmetic Act to set forth provisions governing the Food and Drug Administration's (FDA's) regulation of cosmetics, including requiring the registration of manufacturing establishments and the submission of a cosmetic and ingredient statement for each cosmetic. The FDA must publish a list of registered establishments and a list of cosmetics and their ingredients. Cosmetic manufacturers, packers, and distributors must report to the FDA any serious and unexpected
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Sponsored by: Rep. Pete Sessions
Referred To The Subcommittee On Health. on 11/20/2015
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Combination Drug Development Incentive Act of 2015 [HB-406]
Combination Drug Development Incentive Act of 2015 This bill amends the Federal Food, Drug, and Cosmetic Act to provide a five-year marketing exclusivity period to a new drug approved by the Food and Drug Administration that is a novel combination of active ingredients. The application for the combination drug must contain reports of new clinical investigations that are essential to approval and were conducted or sponsored by the applicant. Currently, a new drug that includes an active ingredient that has already been approved is provided a three-year
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Sponsored by: Rep. Jason Chaffetz
Referred To The Subcommittee On Health. on 01/23/2015
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E-Free Act [HB-3920]
E-Free Act This bill requires the Food and Drug Administration to withdraw approval for Essure, a medical device for permanent, non-surgical female sterilization.
Sponsored by: Sen. Marsha Blackburn
Sponsor Introductory Remarks On Measure. (cr H9210) on 12/10/2015
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RaD Fund Act Rare Disease Fund Act [HB-3731]
RaD Fund Act Rare Disease Fund Act This bill requires the National Institutes of Health (NIH) to organize the Rare Disease Therapeutics Corporation to purchase rights to, fund the development of, and sell ownership interests in drugs, biological products, and medical devices for rare diseases. The NIH must sell stock in the corporation to investors as soon as practicable. The corporation and the NIH may enter into an agreement under which the NIH maintains an ownership interest in the corporation in exchange for providing the corporation with intellectual
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Sponsored by: Rep. Thomas Rooney
Referred To The Subcommittee On Health. on 10/16/2015
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Preserving Access to Orphan Drugs Act of 2015 [HB-3678]
Preserving Access to Orphan Drugs Act of 2015 This bill amends the Patient Protection and Affordable Care Act to expand the definition of orphan drug for purposes of the annual fee paid by brand name prescription drug manufacturers and importers to include medications for rare conditions that were, prior to 2011, approved or in clinical trials. (Drug manufacturers and importers pay an annual fee based on their sales of brand name prescription drugs, excluding sales of orphan drugs.) Currently, only medications for rare conditions for which a tax
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Sponsored by: Rep. Adam Kinzinger
Referred To The Subcommittee On Health. on 10/02/2015
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Opioid Abuse Prevention and Treatment Act of 2015 [HB-3677]
Opioid Abuse Prevention and Treatment Act of 2015 This bill requires the Department of Health and Human Services (HHS) to award grants to states to develop a peer review process to identify and investigate questionable or inappropriate prescribing and dispensing patterns of drugs classified as schedule II or III under the Controlled Substances Act, which are drugs with an accepted medical use that have the potential to be abused and addictive. This bill amends the Public Health Service Act to require HHS to establish grant programs to: (1) facilitate
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Sponsored by: Rep. Sean Maloney
Referred To The Subcommittee On Health. on 10/02/2015