Food and Drug Administration Safety and Innovation Act

Food and Drug Administration Safety and Innovation Act - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to reauthorize and establish new Food and Drug Administration (FDA) prescription drug user-fee programs and revise and impose new 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. Title I: Fees Relating to Drugs - Prescription Drug User Fee Amendments of 2012 - (Sec. 103) Extends through FY2017 the authority of the Secretary of Health and Human Services (HHS) to assess and collect human drug application and supplement fees, prescription drug establishment fees, and prescription drug product fees to support the FDA drug development process and the process for the review of human drug applications. Increases for FY2013-FY2017 the level of required prescription drug user fee revenues. Provides for an inflation adjustment and a workload adjustment for FY2013 and for FY2014 and subsequent fiscal years for the required level of user fee revenue amounts.

Requires the Secretary, not later than 60 days before the start of each fiscal year, to establish, for the next fiscal year, application, product, and establishment fees based on revenue amounts established by this title.

(Sec. 104) Requires the Secretary to prepare and submit to the House Committee on Energy and Commerce and the Senate Committee on Health, Education, Labor, and Pensions (specified congressional committees) after the end of each fiscal year for which user fees are collected under this title (beginning with FY2013) a report on the progress of the FDA in achieving the goals identified in the letters sent by the Secretary to the Committees, the future plans of the FDA, and the progress of the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research in achieving such goals.

Requires such report to include, for each review division, per fiscal year, the number of: (1) original standard new drug applications and biologics license applications filed, (2) priority new drug applications and biologics license applications filed, (3) standard efficacy supplements, (4) priority efficacy supplements, (5) applications filed for review under accelerated approval, (6) applications filed for review as fast track products, (7) applications filed for orphan-designated products, and (8) breakthrough designations.

The summary continues for 112 more paragraphs. Read it in full on Congress.gov

Written by analysts at the Congressional Research Service and published on Congress.gov, not by Civibrief. Summarized at the "Public Law" stage on July 9, 2012. It describes the bill, it is not the legal text.

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