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Final PDUFA Recommendations Transmitted to Congress Will Strengthen Drug Review and Drug Safety


The U.S. Food and Drug Administration (FDA) recently submitted to Congress its final proposal for reauthorizing the Prescription Drug User Fee Act (PDUFA IV) after reviewing public comments.

PDUFA provides user fee funds, paid by brand drug and biotechnology companies that are added to appropriated funds to support the review of new human drugs. Since 1992, when PDUFA was first enacted, FDA has provided the public with 1,220 new drugs and biologics. The current user fee program is scheduled to expire on September 30, 2007.

“The reauthorization of this law plays a significant role in FDA’s continued ability to make drug therapies available to the American public in a timely fashion without sacrificing the quality of approval decisions,” said Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs. “Our proposed recommendations for PDUFA IV aim to strengthen our drug safety system and upgrade resources to enhance FDA’s information technology capability.”

Key goals for PDUFA IV include placing PDUFA on a sound financial footing, enhancing premarket review, and creating a modern post-market drug safety system that follows products across their full life cycle.

FDA is also proposing $6.25 million in new user fees for a voluntary program to review direct-to-consumer television advertisements for accuracy and balance prior to airing. This new program would support 27 additional staff and would be phased in over five years.

The package delivered to Congress includes FDA’s proposed changes to the bill, a letter spelling out the agency’s review performance goals for fiscal years 2008 through 2012, and a performance goal letter detailing the agency’s performance goals and procedures for direct-to-consumer television advertising over the same five-year period.

These documents were developed after reviewing public comments submitted to FDA following a January Federal Register notice and a public hearing held in February.

Most of the public comment supported PDUFA reauthorization and endorsed expanding the agency’s post-market safety initiatives. However, the performance goal letter was modified in response to public comments.

The definition of a Type A meeting -- the most urgent meeting with FDA—was changed to include meetings about important safety issues and to commit to holding 90 percent of those meetings within 30 days of a request.

FDA also proposes revised language clarifying the agency’s commitment to combine its current approach to collecting safety data with methods that actively seek information about medications and adverse events.

Under PDUFA IV, annual user fees would be increased to $392.8 million, an $87.4 million increase over PDUFA III.

The initial proposal was $37.9 million in program enhancements, including $29.3 million to hire an additional 82 employees for post-market safety activities, $4.6 million to draft guidance for FDA reviewers and industry and $4 million to move FDA towards an all-electronic drug review system. In addition, $17.7 million would be used to pay for salary and benefit increases; $11.7 million would pay increased rents and the costs of the agency’s move to the new White Oak facility in Silver Spring, Md.; and $20 million would cover significant increases in FDA’s drug review workload that were incurred but not compensated for under PDUFA III. Under the law these costs can be supported under PDUFA IV and these costs are expected to continue.


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