/publications/issue/2006/2006-04/2006-04-5434

FDA DRAWS FIRE FOR FOOT-DRAGGING

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Acting FDA Commissioner Andrew von Eschenbach,MD, came under fire on Capitol Hill for the agency's slow-footed approach to approving the sale of new generic drugs. During testimony before the House Agriculture Appropriations Subcommittee, congressmen from both parties expressed concern over recent reports that the FDA's backlog of generic drugs awaiting approval has grown to more than 800 applications.

Although the Bush Administration has asked for a substantial budget increase for the FDA in 2007, most of that money will be earmarked for "pandemic preparedness" and protecting the food supply from terrorist attacks. Despite the growing approval backlog, the FDA has not asked for any increase in funding for its Office of Generic Drugs (OGD).

In his testimony before the subcommittee, Dr. von Eschenbach said the agency has no plans to increase the 200-member staff at OGD, even though there is evidence that the office will receive even more abbreviated new drug applications for generics during 2006. Although the law requires the FDA to complete its review of each application within 6 months, last year the generics office took an average of 20.5 months to accomplish that—up from 19.9 months in 1999.