FDA ANNOUNCES "GIVE" PROGRAM TO SPEED GENERIC DRUG APPROVALS

The FDA has unveiled a new programdesigned to boost the number and variety ofgeneric-drug products over the next few years. The plan, known asthe Generic Initiative for Value and Efficiency, or GIVE, involves significantstaffing increases for the FDA generic-drug review team, aswell as a streamlined approval system that officials predict willbring important generic products to the market "much faster" thanthe current approach.

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

The agency's efforts to bring cost-saving generic drugs to pharmacyshelves is already paying off, with generic-product approvalsclimbing 30% in fiscal year 2007 to a record 682 drugs. To boostthat approval rate even faster, the GIVE initiative empowers theFDA to revise the review order for certain drug applications toplace extra emphasis on generics expected to have substantialmarket impact.

As an example, FDA Generic Drug Director Gary Buehler explainedthat "first generic products," for which there are no blocking patentsor exclusivity protections on the reference listed drug, will be earmarkedby the agency for expedited review."This will mean that theseproducts, for which there are currently no generic products on themarket, may reach the consumer much faster," agency officials said.

The GIVE initiative also calls for hiring and training new staffers tobolster the 215 FDA employees currently assigned to reviewinggeneric-drug applications.The FDA also plans to place more emphasison the use of electronic programs for handling drug submissionsand internal documents. Additionally, the FDA said that the agencywill increase its communications with generic-drug manufacturersto help sponsors of these products submit clean applications thatcan be processed with minimal delay. For a related article, pleasevisit www.pharmacytimes.com/give.