Drug Safety, Medical Device, And Laboratory Regulation
US Congress 113th Congress
Act to Ban Zohydro [HB-4241]
Act to Ban Zohydro - Ends the sale and distribution of pure hydrocodone bitartrate extended-release capsules (marketed as Zohydro ER) within 45 days by withdrawing approval for its new drug application. Prohibits the Commissioner of Food and Drugs (FDA) from approving any new drug application for the capsules unless they are formulated to prevent abuse.
Sponsored by: Rep. Janice Schakowsky
Referred To The Subcommittee On Health. on 03/14/2014
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Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2014 [HB-4187]
Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2014 or DISARM Act of 2014 - Amends title XVIII (Medicare) of the Social Security Act to direct the Secretary of Health and Human Services (HHS) to: (1) recognize the costs of new 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 new antimicrobial drugs, and (4) further reduce
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Sponsored by: Rep. Robert Brady
Referred To The Subcommittee On Health. on 03/14/2014
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PACT Act [HB-3969]
Preventing Abuse of Cough Treatments Act of 2014 or the PACT Act - Amends the Federal Food, Drug, and Cosmetic Act to prohibit the sale or offering for sale of a drug containing dextromethorphan, and not subject to practitioner supervision requirements, to an individual under age 18, except if the sale is made: (1) pursuant to a validly issued prescription; or (2) to an individual who provides proof of being actively enrolled in the military, including a valid military identification card. Imposes civil monetary penalties that escalate upon repeated
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Sponsored by: Rep. H. Morgan Griffith
Referred To The Subcommittee On Health. on 02/07/2014
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Antibiotic Development to Advance Patient Treatment Act of 2013 [HB-3742]
Antibiotic Development to Advance Patient Treatment Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to authorize the Secretary of Health and Human Services (HHS) to approve the use of an antibacterial or antifungal drug that is intended for treatment of a serious or life-threatening disease or condition to treat a limited population of patients for which there is an unmet medical need. Requires the labeling of such drugs to prominently include in the prescribing information the statement that the drug is indicated for use in
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Sponsored by: Rep. James Langevin
Referred To The Subcommittee On Health. on 12/13/2013
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Personal Drug Importation Fairness Act of 2013 [HB-3715]
Personal Drug Importation Fairness Act of 2013 - Allows a drug to be imported into the United States, and re-imported into the United States by a person other than the drug's manufacturer, if the drug: (1) has the same active ingredients, route of administration, and strength as a prescription drug approved under provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA) regarding adulterated drugs; (2) may be lawfully marketed in, and is imported or reimported from, a qualified country; (3) is dispensed by a licensed pharmacist; (4) is shipped
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Sponsored by: Rep. Janice Schakowsky
Referred To The Subcommittee On Health. on 12/13/2013
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Excellence in Diagnostic Imaging Utilization Act of 2013 [HB-3705]
Excellence in Diagnostic Imaging Utilization Act of 2013 - Amends title XVIII (Medicare) of the Social Security Act (SSA) to establish appropriateness requirements for certain outpatient advanced diagnostic imaging services for which payment is made under the technical or professional component of the physicians' fee schedule or the prospective payment system for hospital outpatient department services. Defines "applicable advanced diagnostic imaging services" as those for which defined appropriate use criteria (and related guidelines) have been:
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Sponsored by: Rep. Erik Paulsen
Referred To The Subcommittee On Health. on 12/13/2013
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Accelerating Innovation in Medicine Act of 2013 [HB-3681]
Accelerating Innovation in Medicine Act of 2013 or AIM Act of 2013 - Amends title XVIII (Medicare) of the Social Security Act to direct the Secretary of Health and Human Services (HHS) to develop an 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 for it and for any related services.
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Sponsored by: Rep. John Shimkus
Referred To The Subcommittee On Health. on 12/13/2013
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Small Manufacturer Protection Act of 2013 [HB-3631]
Small Manufacturer Protection Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services (HHS) to grant the owner of a human generic drug facility a waiver from, or reduction of, one or more human generic drug fees if the Secretary finds that the assessment of the fee would present a significant barrier to market entry because of the owner's limited resources or other circumstances. Requires an owner seeking such fee waiver or reduction to submit a written request no later than 180 days after
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Sponsored by: Rep. David Roe
Referred To The Subcommittee On Health. on 12/06/2013
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Patient Centered Healthcare Savings Act of 2013 [HB-3622]
Patient Centered Healthcare Savings Act of 2013 - Repeals the Patient Protection and Affordable Care Act (PPACA) and the health care requirements of the Health Care and Education Reconciliation Act of 2010, effective as of their enactment. Restores or revives provisions amended or repealed by such Act or such health care requirements. Sets conditions for lawsuits arising from health care liability claims regarding health care goods or services or any medical product affecting interstate commerce. Establishes a statute of limitations and limits
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Sponsored by: Rep. Sean Duffy
Referred To The Subcommittee On The Constitution And Civil Justice. on 01/27/2014
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Medicare Part D Patient Safety and Drug Abuse Prevention Act of 2013 [HB-3392]
Medicare Part D Patient Safety and Drug Abuse Prevention Act of 2013 - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act (SSA) to establish a safe pharmacy access program under which a prescription drug plan (PDP) sponsor (or a Medicare Advantage (MA) organization offering an MA-PD plan) shall have in place procedures designed to prevent fraud and abuse in the dispensing of certain controlled substances under Medicare part D. Allows a PDP sponsor to suspend payments and clean claim
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Sponsored by: Rep. Gus Bilirakis
Referred To The Subcommittee On Health. on 11/01/2013
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Innovation Act [HB-3309]
Innovation Act - (Sec. 3) Directs a party alleging infringement in a civil action involving a claim for relief arising under any Act of Congress relating to patents to include in the court pleadings, unless the information is not reasonably accessible, specified details concerning: each claim of each patent allegedly infringed, including each accused process, machine, manufacture, or composition of matter (referred to as an "accused instrumentality") alleged to infringe the claim; for each claim of indirect infringement, the acts of the alleged
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Sponsored by: Rep. Peter DeFazio
Received In The Senate And Read Twice And Referred To The Committee On The Judiciary. on 12/09/2013
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Sensible Oversight for Technology which Advances Regulatory Efficiency Act of 2013 [HB-3303]
Sensible Oversight for Technology which Advances Regulatory Efficiency Act of 2013 or the SOFTWARE Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act (FDCA) to apply it to medical software to the same extent and in the same manner as it applies to devices. Defines "medical software" as software that is intended to be marketed: to directly change the structure or any function of the body of man or other animals; or for use by consumers and makes recommendations for clinical action that includes the use of a drug, device, or procedure
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Sponsored by: Rep. H. Morgan Griffith
Referred To The Subcommittee On Health. on 10/25/2013
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Drug Quality and Security Act [HB-3204]
Drug Quality and Security Act - Title I: Drug Compounding - Compounding Quality Act - (Sec. 102) Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) with respect to the regulation of compounding drugs. Exempts compounded drugs from new drug requirements, labeling requirements, and track and trace requirements if the drug is compounded by or under the direct supervision of a licensed pharmacist in a registered outsourcing facility and meets applicable requirements. Establishes annual registration requirement for any outsourcing facility. Requires
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Sponsored by: Rep. H. Morgan Griffith
Became Public Law No: 113-54. on 11/27/2013
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MODDERN Cures Act of 2013 [HB-3116]
Modernizing Our Drug & Diagnostics Evaluation and Regulatory Network Cures Act of 2013 or MODDERN Cures Act of 2013 - Requires the Secretary of Health and Human Services (HHS) to: (1) establish the Advanced Diagnostics Education Council to recommend standard terms and definitions related to innovative diagnostics for use by patients, physicians, health care providers, payers, and policy makers; and (2) publish a guide regarding such terms and definitions. Sets forth additional factors for the Secretary to consider in determining the payment amount
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Sponsored by: Rep. Barbara Lee
Referred To The Subcommittee On Courts, Intellectual Property, And The Internet. on 01/09/2014
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MODDERN Cures Act of 2013 [HB-3091]
Modernizing Our Drug & Diagnostics Evaluation and Regulatory Network Cures Act of 2013 or MODDERN Cures Act of 2013 - Requires the Secretary of Health and Human Services (HHS) to: (1) establish the Advanced Diagnostics Education Council to recommend standard terms and definitions related to innovative diagnostics for use by patients, physicians, health care providers, payers, and policy makers; and (2) publish a guide regarding such terms and definitions. Sets forth additional factors for the Secretary to consider in determining the payment amount
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Sponsored by: Rep. David Loebsack
Referred To The Subcommittee On Courts, Intellectual Property, And The Internet. on 10/15/2013
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Compounding Clarity Act of 2013 [HB-3089]
Compounding Clarity Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to revise requirements for the regulation of compounding drugs. Revises the exemption of compounded drugs from certain new drug, labeling, and biological product requirements. Adds an exemption for drug products compounded by a licensed pharmacist or a licensed physician, pursuant to a non-patient-specific purchase order, which: (1) will be administered by a health care practitioner within a physician's office, a hospital, or another health care setting; and
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Sponsored by: Rep. Robert Wittman
Referred To The House Committee On Energy And Commerce. on 09/12/2013
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Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 [HB-307]
Pandemic and All-Hazards Preparedness Act Reauthorization of 2013 - Title I: Strengthening National Preparedness and Response for Public Health Emergencies - (Sec. 101) Amends the Public Health Service Act (PHSA) to require the Secretary of Health and Human Services (HHS) to submit the National Health Security Strategy to the relevant congressional committees in 2014. Revises the Strategy's preparedness goals, in part to specify that the drills and exercises included in periodic evaluations of federal, state, local, and tribal preparedness and response
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Sponsored by: Rep. Frank Pallone
Became Public Law No: 113-5. on 03/13/2013
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S.A.F.E. Compounded Drugs Act of 2013 [HB-3019]
Supporting Access to Formulated and Effective Compounded Drugs Act of 2013 or S.A.F.E. Compounded Drugs Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) with respect to the regulation of compounded drugs. Eliminates authority for compounding pharmacies to compound any drug product that is a copy of a commercially available drug. Prohibits such pharmacies from compounding: (1) any drug product appearing on a list of active ingredients and dosage forms that the Secretary of Health and Human Services (HHS) determines should not
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Sponsored by: Rep. Nita Lowey
Sponsor Introductory Remarks On Measure. (cr E1223) on 08/02/2013
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Medical Testing Availability Act of 2013 [HB-3005]
Medical Testing Availability Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act with respect to labeling in the shipment or delivery of an in vitro diagnostic product for an investigation exempt from compliance with a performance standard or the requirement of premarket approval. Declares that such a product whose labeling states "For Research Use Only. Not for use in diagnostic procedures." may not be deemed misbranded on the basis that its manufacturer or distributor: (1) sells the product to an end user who uses the product in a manner
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Sponsored by: Rep. Jackie Speier
Referred To The House Committee On Energy And Commerce. on 08/02/2013
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Combination Drug Development Incentive Act of 2013 [HB-2985]
Combination Drug Development Incentive Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act with respect to the five-year bar on a new drug application (or abbreviated drug application) by anyone that has not obtained a right of reference or use from the original and approved drug approval applicant by or for whom investigations under the original, subsequently approved application were conducted. Applies this five-year bar, and the requirement of a grant of a right of reference or use, with respect to an approved drug application (or abbreviated
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Sponsored by: Rep. Jason Chaffetz
Referred To The House Committee On Energy And Commerce. on 08/02/2013