The agency notes that generics are cheaper as it announces GIVE - the Generic Initiative for Value and Efficiency - as a way to move the approval process along. Although the FDA approved or tentatively approved 682 generics in fiscal year 2007, or 30 percent more than the previous year, FDA commish Andy von Eschenbach wants to pick up the pace. And he’s going to hire more people to get it done. (Read more here).

Faced with a backlog of 1,300 applications, up from about 800 about a year ago, the FDA is revising the review order for certain drug applications. For example, the agency says first generic products, for which there are no blocking patents or exclusivity protections on the reference listed drug, are identified at the time of submission for expedited review. This will mean that these products, for which there are currently no generic products on the market, may reach the consumer faster.

FDA now has about 215 full-time staff reviewing generic applications. Under GIVE, FDA will hire and train new generic drug reviewers and focus on enhanced use of electronic programs for handling drug submissions and internal documents. No word, though, on how many new hires will be made. When possible, resources from other FDA departments will be engaged in the effort. The agency also promises to increase its communications with generic drugmakers and provide training on proper application submission to the industry in meetings and Webcasts.