OFFICIALS LEGISLATION INTEREST GROUPS PUBLIC STATEMENTS COMMITTEES VETOES

DeLauro: Increasing Industry Influence at FDA Will Not Solve Generic Application Backlog

Date: Feb. 17, 2006
Location: Washington, DC
Issues: Drugs


DeLauro: Increasing Industry Influence at FDA Will Not Solve Generic Application Backlog

WASHINGTON, D.C. - Congresswoman Rosa L. DeLauro (Conn.-3), the ranking member of the House Appropriations Agriculture subcommittee, today issued the following statement in response to reports that FDA will call for user fees for the generic drug industry. DeLauro questioned acting FDA Commissioner Dr. Andrew von Eschenbach about generics yesterday at a hearing before her subcommittee.

"Generic drugs provide a low-cost alternative for countless Americans that require prescription drugs and may not be able to afford brand named medications. Increasing the availability of generics is more important than ever with the costs of prescription drugs rising at a level higher than inflation. Yet the backlog in applications of generic drugs at FDA is delaying these critical, life-saving drugs from entering the market.

"For that reason, FDA must be working aggressively to address this backlog of more than 800 applications - an all time high - by looking internally at budget and staffing levels to adequately resolve the breakdown that led to this dilemma. According to reports, the Office of Generic Drugs operated with 200 employees to review almost 800 applications last year, while the offices that review new drugs had more than 2,5000 employees for about 150 applications in 2004. Why has the FDA not asked Congress for an increase in their budget before making this proposal?

"This agency had an opportunity to discuss funding levels for generics at the House Agriculture Appropriations hearing yesterday, but it was members of the subcommittee that first raised the issue. I am concerned that following this opportunity, FDA will instead impose user fees on the generics industry. Imposing user fees on an industry it is charged with regulating will only increase industry influence at FDA."

http://www.house.gov/delauro/press/2006/February/FDA_backlog_2_17_06.html

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