Drug Safety, Medical Device, And Laboratory Regulation
US Congress 115th Congress
Preserving Patient Access to Compounded Medications Act of 2017 [HB-2871]
Preserving Patient Access to Compounded Medications Act of 2017 This bill amends the Federal Food, Drug, and Cosmetic Act to expand the circumstances under which a drug may be compounded (manufactured at small scale) to allow pharmacists and physicians to compound drugs for administration to patients in an office or clinical setting, in accordance with state law. (Drugs that are compounded do not need to meet certain federal requirements regarding manufacturing, labeling, or approval.) Dietary supplements may be used in the compounding of a drug.
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Sponsored by: Rep. Mike Johnson
Referred To The Subcommittee On Health. on 06/16/2017
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Horseracing Integrity Act of 2017 [HB-2651]
Horseracing Integrity Act of 2017 This bill establishes the Horseracing Anti-Doping and Medication Control Authority as an independent non-profit corporation with responsibility for developing and administering an anti-doping and medication control program for: (1) Thoroughbred, Quarter, and Standardbred horses that participate in horse races that have a substantial relation to interstate commerce, (2) such horse races, and (3) the personnel engaged in the care, training, or racing of such horses. The Federal Trade Commission (FTC) shall have exclusive
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Sponsored by: Rep. Alexander Mooney
Subcommittee Hearings Held. on 06/22/2018
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Promoting Life-Saving New Therapies for Neonates Act of 2017 [HB-2641]
Promoting Life-Saving New Therapies for Neonates Act of 2017 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 05/26/2017
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FDA Regulatory Efficiency Act [S.1183]
FDA Regulatory Efficiency Act This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to establish a third-party quality system assessment program to accredit persons to assess whether a medical device manufacturer's quality system can ensure the safety and effectiveness or substantial equivalence of an approved medical device after certain changes, including changes in manufacturing or changes to enhance device safety. Device manufacturers with quality systems that have been certified by an accredited
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Sponsored by: Sen. Joe Donnelly
Read Twice And Referred To The Committee On Health, Education, Labor, And Pensions. on 05/18/2017
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To amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments and for granting export certifications. [HB-1736]
To amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments and for granting export certifications. This bill amends the Federal Food, Drug, and Cosmetic Act to revise provisions regarding Food and Drug Administration (FDA): (1) inspections of establishments that manufacture or process medical devices, and (2) certification of medical devices for export. The biannual inspection schedule for medical device establishments handling higher risk devices is replaced with a risk-based schedule. In establishing
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Sponsored by: Sen. Marsha Blackburn
Referred To The Subcommittee On Health. on 03/31/2017
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ACCESS Act of 2017 Accessible Care by Curbing Excessive lawSuitS Act of 2017 [HB-1704]
ACCESS Act of 2017 Accessible Care by Curbing Excessive lawSuitS Act of 2017 This bill establishes provisions governing health care lawsuits where coverage for the care was provided or subsidized by the federal government. The bill does not preempt certain state laws and federal vaccine injury laws and rules. The statute of limitations is three years after the injury or one year after the claimant discovers the injury, whichever occurs first, with exceptions. Noneconomic damages are limited to $250,000. Juries may not be informed of this limitation.
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Sponsored by: Rep. Lloyd Smucker
Referred To The Subcommittee On The Constitution And Civil Justice. on 04/06/2017
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Medical Product Communications Act of 2017 [HB-1703]
Medical Product Communications Act of 2017 This bill amends the Federal Food, Drug, and Cosmetic Act to state that the intended use of a drug, biological product, or device shall be determined by the objective intent of the manufacturer and sponsor of such drug, biological product, or device, as demonstrated by statements contained in labeling, advertising, or analogous oral statements. The intended use of these medical products shall not be determined by actual or constructive knowledge of the manufacturer or sponsor that these products will be
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Sponsored by: Rep. H. Morgan Griffith
Referred To The Subcommittee On Health. on 03/24/2017
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Over-the-Counter Hearing Aid Act of 2017 [HB-1652]
Over-the-Counter Hearing Aid Act of 2017 This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to categorize certain hearing aids as over-the-counter hearing aids and issue regulations regarding those hearing aids. The regulations for over-the-counter hearing aids must: (1) provide reasonable assurances of safety and efficacy; (2) establish output limits and labeling requirements; and (3) describe requirements for the sale of hearing aids in-person, by mail, or online, without a prescription.
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Sponsored by: Rep. James McGovern
Referred To The Subcommittee On Health. on 03/24/2017
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Over-the-Counter Hearing Aid Act of 2017 [S.670]
Over-the-Counter Hearing Aid Act of 2017 This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to categorize certain hearing aids as over-the-counter hearing aids and issue regulations regarding those hearing aids. The regulations for over-the-counter hearing aids must: (1) provide reasonable assurances of safety and efficacy; (2) establish output limits and labeling requirements; and (3) describe requirements for the sale of hearing aids in-person, by mail, or online, without a prescription.
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Sponsored by: Sen. Susan Collins
Read Twice And Referred To The Committee On Health, Education, Labor, And Pensions. on 03/21/2017
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Preservation of Antibiotics for Medical Treatment Act of 2017 [HB-1587]
Preservation of Antibiotics for Medical Treatment Act of 2017 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
Assuming First Sponsorship - Ms. Delauro Asked Unanimous Consent That She May Hereafter Be Considered As The First Sponsor Of H.r. 1587 A Bill Originally Introduced By Former Representative Slaughter, For Purposes Of Adding Cosponsors And Requesting Reprintings Pursuant To Clause 7 Of Rule Xii. Agreed To Without Objection. on 05/08/2018
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Protecting Our Kids' Medicine Act of 2017 [HB-1586]
Protecting Our Kids' Medicine Act of 2017 This bill amends the Federal Food, Drug, and Cosmetic Act to prohibit the sale of liquid formulations of over-the-counter drugs that are not packaged with a dosage delivery device, such as a calibrated cup or spoon, and that do not have measurements on the label and on the dosage delivery device exclusively in metric units. The Food and Drug Administration may waive the requirement for metric units if that requirement would not benefit public health. Over-the-counter liquid drugs labeled for pediatric use
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Sponsored by: Rep. Jose Serrano
Referred To The Subcommittee On Health. on 03/17/2017
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Preventing Antibiotic Resistance Act of 2017 [S.629]
Preventing Antibiotic Resistance Act of 2017 This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to refuse a new animal drug application if the drug is a medically important antimicrobial used to treat humans and the applicant fails to demonstrate that the drug meets specified criteria for use in animals, including that: (1) the drug is effective, (2) the drug is targeted to animals at risk of developing a specific bacterial disease, (3) the drug has a defined duration of therapy, and (4) there
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Sponsored by: Sen. Jack Reed
Read Twice And Referred To The Committee On Health, Education, Labor, And Pensions. on 03/14/2017
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Safe and Affordable Drugs from Canada Act of 2017 [HB-1480]
Safe and Affordable Drugs from Canada Act of 2017 This bill 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;
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Sponsored by: Rep. Steve Cohen
Referred To The Subcommittee On Health. on 03/10/2017
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Medical Innovation Prize Fund Act [S.495]
Medical Innovation Prize Fund Act This bill denies any person the exclusive right to manufacture, distribute, sell, or use a drug, a biological product, or a medication manufacturing process. The bill establishes the Fund for Medical Innovation Prizes to provide for prize payments in lieu of market exclusivity. The Board of Trustees of the fund must award prize payments to: (1) the first person to receive approval for a medication; (2) the holder of the patent for a manufacturing process; and (3) persons or communities that contributed to the development
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Sponsored by: Sen. Bernard Sanders
Read Twice And Referred To The Committee On Health, Education, Labor, And Pensions. on 03/02/2017
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DXM Abuse Prevention Act of 2017 [HB-1271]
DXM Abuse Prevention Act of 2017 This bill amends the Federal Food, Drug, and Cosmetic Act to: (1) require a retailer that sells certain drugs containing dextromethorphan (DXM) to have a verification system that is intended to ensure that no one under 18 years of age purchases such drugs from the retailer, (2) establish other restrictions on the sale of over-the-counter drugs containing DXM, and (3) establish restrictions on the distribution of bulk DXM.
Sponsored by: Rep. Alcee Hastings
Referred To The Subcommittee On Health. on 03/17/2017
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CCM-CARE Act Cerebral Cavernous Malformations Clinical Awareness, Research, and Education Act of 2017 [HB-1255]
CCM-CARE Act Cerebral Cavernous Malformations Clinical Awareness, Research, and Education Act of 2017 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 03/03/2017
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Affordable and Safe Prescription Drug Importation Act [HB-1245]
Affordable and Safe Prescription Drug Importation Act
Sponsored by: Rep. Barbara Lee
Referred To The Subcommittee On Health. on 03/03/2017
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CCM-CARE Act Cerebral Cavernous Malformations Clinical Awareness, Research, and Education Act of 2017 [S.475]
CCM-CARE Act Cerebral Cavernous Malformations Clinical Awareness, Research, and Education Act of 2017 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. Tom Udall
Read Twice And Referred To The Committee On Health, Education, Labor, And Pensions. on 02/28/2017
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Affordable and Safe Prescription Drug Importation Act [S.469]
Affordable and Safe Prescription Drug Importation Act
Sponsored by: Sen. Robert Casey
Read Twice And Referred To The Committee On Health, Education, Labor, And Pensions. on 02/28/2017
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RACE for Children Act Research to Accelerate Cures and Equity for Children Act [HB-1231]
RACE for Children Act Research to Accelerate Cures and Equity for Children Act This bill amends the Federal Food, Drug, and Cosmetic Act to expand Food and Drug Administration (FDA) requirements for sponsors of certain drugs and biological products for adult cancer to assess the use of their medications in pediatric populations. (Currently, applications for FDA approval of new medications or new uses of medications must include pediatric assessments of safety and effectiveness for claimed indications, with exceptions.) The pediatric assessment for
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Sponsored by: Rep. Ted Poe
Referred To The Subcommittee On Health. on 03/03/2017