Pharmacy Times

FDA ANNOUNCES "GIVE" PROGRAM TO SPEED GENERIC DRUG APPROVALS


The FDA has unveiled a new program designed to boost the number and variety of generic-drug products over the next few years. The plan, known as the Generic Initiative for Value and Efficiency, or GIVE, involves significant staffing increases for the FDA generic-drug review team, as well as a streamlined approval system that officials predict will bring important generic products to the market "much faster" than the current approach.

"Generic drugs generally cost less than their brand-name counterparts, and competition among generics has been a key factor in lowering drug prices," the FDA said in announcing the new initiative. "The GIVE plan outlines ways to maximize the use of our resources so that [the] FDA can review and approve even more high quality generic drugs during the upcoming fiscal year than it did in 2007."

The agency's efforts to bring cost-saving generic drugs to pharmacy shelves is already paying off, with generic-product approvals climbing 30% in fiscal year 2007 to a record 682 drugs. To boost that approval rate even faster, the GIVE initiative empowers the FDA to revise the review order for certain drug applications to place extra emphasis on generics expected to have substantial market impact.

As an example, FDA Generic Drug Director Gary Buehler explained that "first generic products," for which there are no blocking patents or exclusivity protections on the reference listed drug, will be earmarked by the agency for expedited review."This will mean that these products, for which there are currently no generic products on the market, may reach the consumer much faster," agency officials said.

The GIVE initiative also calls for hiring and training new staffers to bolster the 215 FDA employees currently assigned to reviewing generic-drug applications.The FDA also plans to place more emphasis on the use of electronic programs for handling drug submissions and internal documents. Additionally, the FDA said that the agency will increase its communications with generic-drug manufacturers to help sponsors of these products submit clean applications that can be processed with minimal delay. For a related article, please visit www.pharmacytimes.com/give.