S. 2516 (112th): Food and Drug Administration Safety and Innovation Act

May 07, 2012 (112th Congress, 2011–2013)
Died (Reported by Committee)
See Instead:

S. 3187 (same title)
Signed by the President — Jul 09, 2012

Thomas “Tom” Harkin
Junior Senator from Iowa
Read Text »
Last Updated
May 07, 2012
314 pages
Related Bills
S. 3187 (Related)
Food and Drug Administration Safety and Innovation Act

Signed by the President
Jul 09, 2012

H.R. 5651 (Related)
Food and Drug Administration Reform Act of 2012

Passed House
Last Action: May 30, 2012


This bill was introduced on May 7, 2012, in a previous session of Congress, but was not enacted.

Introduced May 07, 2012
Reported by Committee May 07, 2012
Full Title

An original bill to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes.


No summaries available.


Senate Health, Education, Labor, and Pensions

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Primary Source

THOMAS.gov (The Library of Congress)

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S. stands for Senate bill.

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GovTrack’s Bill Summary

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Library of Congress Summary

The summary below was written by the Congressional Research Service, which is a nonpartisan division of the Library of Congress.

5/7/2012--Reported to Senate without amendment.
Food and Drug Administration Safety and Innovation Act - 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.
Makes permanent programs to study and provide extended exclusivity periods for new drugs for use in pediatric populations.
Permits the FDA to change a classification of a medical device through an administrative order rather than by regulation.
Expands reporting requirements for manufacturers of prescription drugs.
Provides incentives for the development of new qualified infectious disease products, including: (1) an additional five-year market exclusivity period, and (2) eligibility for priority and fast track review.
Requires the Secretary to: (1) expedite the development and review of new drugs designed to treat a serious or life-threatening disease, and (2) include a risk-benefit analysis in the regulatory decision-making process for prescription drugs.
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 establish a task force to develop and implement a strategic plan for enhancing the Secretary's response to preventing and mitigating drug shortages.
Extends until October 1, 2017, the deadline for applications for elections relating to marketing exclusivity for certain drugs containing single enantiomers.
Extends through FY2017 the authorization of appropriations for Critical Path Public-Private Partnerships to implement the FDA's Critical Path Initiative.
Provides for the regulation of medical gas products.
Directs the Secretary to: (1) issue guidance explaining FDA policy for promoting FDA-regulated medical products using the Internet and social media; (2) report to Congress on initiatives to combat prescription drug abuse; (3) reconsider tanning bed labeling requirements; and (4) submit an integrated management strategy identifying goals for the FDA Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health.

House Republican Conference Summary

The summary below was written by the House Republican Conference, which is the caucus of Republicans in the House of Representatives.

No summary available.

House Democratic Caucus Summary

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