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U.S. Department of Health and Human Services

For Industry

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FDA Implementation of PDUFA III Public Accountability Provisions in Developing Recommendations for PDUFA IV

As part of the PDUFA reauthorization of 2002 (PDUFA III), Congress amended Section 505 of the law to include the following provisions for the process FDA should follow when developing recommendations for PDUFA IV:

(a) Public Accountability.--

(1) Consultation.—In developing recommendations to the Congress for the goals and plans for meeting the goals for the process for the review of human drug applications for the fiscal years after fiscal year 2007, and for the reauthorization of sections 735 and 736 of the Federal Food, Drug, and Cosmetic Act, the Secretary of Health and Human Services (referred to in this section as the "Secretary") shall consult with the Committee on Energy and Commerce of the House of Representatives, the Committee on Health, Education, Labor, and Pensions of the Senate, appropriate scientific and academic experts, health care professionals, representatives of patient and consumer advocacy groups, and the regulated industry.

(2) Recommendations.--The Secretary shall publish in the Federal Register recommendations under paragraph (1), after negotiations with the regulated industry; shall present such recommendations to the congressional committees specified in such paragraph; shall hold a meeting at which the public may present its views on such recommendations; and shall provide for a period of 30 days for the public to provide written comments on such recommendations.

 

Publication of FDA proposed recommendations for PDUFA IV (TXT or PDF)

In developing recommendations to the Congress directed FDA to consult with scientific and academic experts, health care professionals, representatives of patient and consumer advocacy groups and the regulated industry. FDA conducted these consultations through a series of meetings, beginning with a public meeting on November 14, 2005 and continuing through June 2006.

Congress further directed FDA to publish recommendations for reauthorization after negotiations with the regulated industry. FDA conducted these negotiations through a series of technical discussions related to additional funding requirements to cover current and expected review program costs for the period FY2008-2012, and the funding needed to support pre-market and expand post-market review capacity and modernization of the drug review and safety information infrastructure. These discussions were coordinated by a Steering Group and carried out in greater detail by 4 subgroups that respectively addressed Financial, Pre-Market review, Post-Market review, Information Technology/Information Management and Direct-to-Consumer Ad review issues.

Per the statute, following negotiations with industry, FDA presented recommendations to key congressional committee staff and published the recommendations in the Federal Register in January of 2007 and held meetings to obtain the public's views of these recommendations in February 2007 (See TXT and PDF Notice of Public Meeting, Feb. 16, 2007).

Following revisions based on this input, the Secretary transmitted to Congress the Administration's recommendations for PDUFA reauthorization.