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United States · Bill · HR

H.R. 5651 (112th)

Food and Drug Administration Reform Act of 2012

openUnited States· United States Congress· EN

Introduced

9 May 2012

Last action

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Status

Received in the Senate. Read twice. Placed on Senate Legislative Calendar under General Orders. Calendar No. 420.

Sponsors

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Subjects

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Source updated

7 April 2025

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Summary

Food and Drug Administration Reform Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to reauthorize and establish new Food and Drug Administration (FDA) prescription drug user-fee programs and revises requirements relating to: (1) prescription, pediatric, and generic drugs; (2) medical devices; (3) biosimilar biological products; (4) new infectious disease drugs; and (5) drug manufacturer reporting. Prescription Drug User Fee Amendments of 2012 - Extends through FY2017 the authority of the Secretary of Health and Human Services (HHS) to assess and collect prescription drug fees to support the FDA drug development and human drug application review process. Medical Device User Fee Amendments of 2012 - Extends through FY2017 the authority of the Secretary to assess and use fees for expediting the review process for medical device applications and for assuring the safety and effectiveness of such devices. Generic Drug User Fee Amendments of 2012 - Directs the Secretary to assess and collect human generic drug user fees through FY2017, including a fee for drug applications pending on October 1, 2012, a drug master file fee, a generic drug facility fee, and an active pharmaceutical ingredient facility fee. Biosimilar User Fee Act of 2012 - Establishes a new program to assess and use fees to expedite the review process for biosimilar biological product applications. Amends the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act to revise and make permanent studies and extended exclusivity periods for new drugs for use in pediatric populations. Authorizes the extension of certain assessment deferrals. Requires, as part of the drug application process, an initial pediatric plan to be submitted prior to required assessments. Requires pre-issuance notice of certain FDA guidance documents to provide a period for stakeholder input and public comment before issuance of a draft. Prohibits draft or final guidance on the regulation of laboratory-developed tests without prior notice to Congress. Revises the medical device premarket review process, including by: (1) prohibiting the disapproval of an application for an investigational device exemption based on marketing decisions or the requirements for approval or clearance of the device, and (2) limiting the clinical data necessary for a device effectiveness determination to the minimum required information to support a reasonable assurance. Prohibits the use of draft guidance dated July 27, 2011, relating to premarket notification of device modifications. Requires guidance dated January 10, 1997, to be reinstated and to remain in effect until any subsequent guidance has been submitted to Congress for a specified period. Establishes a device recall program to assess and identify strategies for mitigating health risks presented by defective or unsafe devices. Modifies the process for requesting classifications of certain low-moderate risk devices upon which there is no legally marketed device to base a determination of substantial equivalence. Authorizes the Secretary to enter into arrangements with nations to harmonize regulatory requirements for inspections, common international labeling symbols of medical devices, and other activities. Reauthorizes, through October 1, 2017, the third party review of certain premarket notification submissions and inspection of certain manufacturing establishments by persons accredited by the Secretary. Expands: (1) exceptions to the prohibition against the for-profit sale of pediatric devices under the exemption from effectiveness requirements for humanitarian devices, and (2) the sentinel postmarket risk identification and analysis system to include and apply to devices. Exempts certain custom devices from performance standards and premarket approval requirements. Sets forth authority for FDA regulation of the drug supply chain, including inspection of domestic and foreign facilities, documentation of imported drugs, and extraterritorial jurisdiction. Authorizes administrative detention and destruction of certain adulterated, misbranded, or counterfeit imported drugs. Establishes criminal penalties for knowingly counterfeiting drugs and increases penalties for the intentional adulteration of drugs having a reasonable probability of causing serious adverse health consequences or death. Establishes a medical gases certification process with expanded FDA regulatory authority. Provides incentives for the development of new qualified infectious disease products (antibacterial or antifungal drugs for human use that treat or prevent infections from qualifying pathogens), including an additional five-year market exclusivity period. Requires the Secretary to expedite the development and review of new drugs designed to treat a serious or life-threatening disease. Extends through FY2017 the authorization of appropriations for Critical Path Public-Private Partnerships to implement the FDA's Critical Path Initiative. Extends until October 1, 2017, the deadline for applications for elections relating to marketing exclusivity for certain drugs containing single enantiomers. Directs the Secretary to report to Congress on initiatives to combat prescription drug abuse. Authorizes modifications of a drug's risk evaluation and mitigation strategy (REMS) with revised assessment standards. Provides for the designation and expedited review of breakthrough therapy drugs to treat serious or life-threatening diseases or conditions. Amends the Orphan Drug Act to extend through FY2017 the authorization of appropriations for grants and contracts for development of drugs for rare diseases and conditions. Revises requirements for the reporting by drug manufacturers to HHS of a discontinuance or interruption in the production of life saving drugs. Requires the Secretary to: (1) request that the Attorney General (DOJ) increase production quotas of certain drugs and ingredients under the Controlled Substances Act as necessary to address shortages, and (2) maintain a drug shortage list.

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10 official files

Placed on Calendar Senate (text)

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