DRW Monthly
December 2007
Issue No. 13

Review of FDA's Generic Initiative for Value and Efficiency (GIVE) Program

The Food and Drug Administration (FDA) unveiled the Generic Initiative for Value and Efficiency (GIVE) program in October 2007 with the goal of streamlining the generic drug approval process within the agency. Under the GIVE program, the FDA is hiring and training new generic drug reviewers and focusing on the enhanced use of electronic programs for handling drug submissions and internal documents(1). It is believed that these efforts will result in an increase in the number of applications reviewed and an expansion in the variety of drugs available to consumers and health professionals.

To this end, GIVE is focused on three key areas:

• mobilizing staff efforts to increase review productivity;
• optimizing the capacity and capability of all assets within the Office of Generic Drugs (OGD) and leveraging wherever possible resources from other FDA components; and
• using every avenue possible to recruit, hire and train reviewers for our critical needs areas.(2)

The GIVE program is of particular importance given the significant increase in generic drug applications submitted to the agency in the past three to four years. "The agency approved or tentatively approved a record of 682 generic drugs products in fiscal year 2007, over 30 percent more than the previous year."(3) Moreover, the growing number of pending applications made it imperative that the agency find a solution to address the growing workload and to improve the efficiency of OGD reviews.

Another development under the GIVE program is the revised review order for generic drug applications for which there are no blocking patents or exclusivity protections on the reference listed drug. These applications will now be assigned an expedited review status which will, in turn, enable the approved generic drugs to reach consumers more quickly. The agency has also increased its communications with generic drug manufacturers and is providing training on proper application submission to the industry through meetings and webcasts.

Although several concerns remain that have the potential to slow down the generic drug approval process such as brand-name pharmaceutical companies that continue to extend brand drug patents to prevent the generic versions from coming to market, the FDA is clearly moving in the right direction. Hopefully, the OGD will continue to introduce new initiatives that will accelerate the generic drug development and approval process.

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