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Angie Drakulich was editorial director of Pharmaceutical Technology.
The US Food and Drug Administration launched a new program to increase the number and variety of generic drugs available to the public, beginning in FY2008.
Rockville, MD (Oct. 4)-The US Food and Drug Administration launched a new program to increase the number and variety of generic drugs available to the public, beginning in fiscal year 2008. The Generic Initiative for Value and Efficiency (GIVE) will use existing resources to help the agency “modernize and streamline the generic drug approval process,” according to FDA.
“To keep pace with the increasing number of generic drug applications, FDA will implement some changes to the generic drug approval process,” said Gary Buehler, director of FDA’s Office of Generic Drugs (OGD), in an agency release. “The GIVE plan outlines ways to maximize the use of our resources so that FDA can review and approve even more high-quality generic drugs during the upcoming fiscal year than it did in 2007.”
More than 600 generic drugs, which cost 30–80% less than brand-name drugs, were approved by FDA in fiscal year 2007. This number represented a 33% increase over fiscal year 2006. Although generic drugs do undergo FDA review before approval, generic drugmakers are not required to repeat the extensive clinical trials that have already been used to develop the original drug, Buehler pointed out. “But they must scientifically demonstrate that their product is bioequivalent” or performs in the same manner as the brand-name product. Generic manufacturers must also demonstrate that the generic version delivers the same amount of its active ingredient over the same amount of time, and uses the same administration route as the brand-name drug.
Under the GIVE initiative, FDA intends to increase the number of applications it reviews and facilitate the review of applications to make more generic drugs available to the public more quickly. These efforts should cut down on the backlog (approximately 1300) of abbreviated new drug applications (ANDAs) within OGD. As a review-oriented program, FDA says that GIVE will focus on:
Specific GIVE improvements in the OGD review process, according to FDA information, will include:
OGD expects that GIVE will have positive results in the near term by providing for greater efficiency in document handling, storage, and retrieval, among other improvements.