US FDA's Resources For Generics "Insufficient"

The US Food and Drug Administration devotes insufficient resources to the review of generic drug products, according to Senator Orrin Hatch.

Sen Hatch is cosponsor, with Senator Harkin, of an amendment to the fiscal 1997 Agriculture, Rural Development, FDA and Related Agencies Appropriations bill. This requires that "a sufficient amount" of agency funds in the next fiscal year shall be used to ensure compliance with the statutory deadlines set forth in Section 505(j)(4)(A) of the Food, Drug & Cosmetic Act. This amendment has been accepted by the Senate.

Sen Hatch told the Senate that FDA resources for review of generic drugs have been declining since 1993. During fiscal 1994, 432 full-time equivalent positions were devoted to this work at the agency, but this level fell to 396 in the following year, rising slightly again to an estimated 397 in fiscal 1996. During fiscal 1997, the agency has estimated that it will devote 390 FTEs to generic drug review.