FDA Strives to Approve Generic Drugs More Quickly

The United States Food and Drug Administration (FDA) unveiled a plan to approve more generic prescription drugs in 2008. The imitative, the Generic Initiative for Value and Efficiency (GIVE) was outlined today, October 4.

The FDA asserts that generic prescription drugs are usually significantly cheaper than brand-name medications. The FDA aims to increase the rate in which they approve new quality generic prescription medications so that physicians and consumers may benefit from them sooner.

The rate at which the FDA has been approving generic drugs has significantly increased over the past few years. In fact, in the fiscal year 2007, the organization approved a record number of 682 generic medications, a 30% increase from the number of generic drugs approved in fiscal year 2006.

GIVE is aimed at approving even more quality generic drugs in the 2008 fiscal year. Gary Beuhler, the director of FDA's Office of Generic Drugs said in a press release, "To keep pace with the number of generic drug applications, FDA will implement some changes to the generic drug approval process. 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 this upcoming fiscal year than it did in 2007."

One change GIVE makes to the generic drug approval process is identifying first generic drugs that possess no exclusivity or patent restrictions at the time of application submission. This will allow the FDA to approve these medications more quickly than they have been able to do in the past.

GIVE also plans to hire additional personnel to the Office of Generic Drugs, which will speed the process by which applications may be approved. These professionals will be trained in utilizing Internet documents and how to handle application submissions to achieve the most efficient system of generic drug approval possible.