FDA to streamline generic drug approval process

The US FDA has announced a programme aimed at increasing the number and variety of generic drug products available to consumers and healthcare providers. The Generic Initiative for Value and Efficiency (GIVE) will help the FDA modernise and streamline its generic drug approval process.

The agency approved or tentatively approved a record 682 generic drug products in fiscal year 2007, more than 30% up on the previous year.

As part of GIVE, the FDA is revising the review order for certain drug applications. For example, 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 much faster.

There are currently 215 full-time staff working on the review of generic drug 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. In addition, FDA will increase its communications with generic drug manufacturers and provide training on proper application submission to the industry.

"To keep pace with the increasing number of generic drug applications, FDA will implement some changes to the generic drug approval process," said Gary Buehler, director of FDA's Office of Generic Drugs. "The GIVE plan outlines ways to maximise the use of our resources so that FDA can review and approve even more high quality generic drugs during the upcoming fiscal year than it did in 2007."