Today, Scott Gottlieb, FDA's Deputy Commissioner for Medical and Scientific Affairs, spoke before the Generic Pharmaceutical Association, responding to the association's criticism of the Agency's generic drug approval process and funding for the Office of Generic Drugs (OGD). He challenged generic drug makers to examine the "root causes" for failed applications, singling out the need for better communication with their API suppliers outside the U.S., to ensure the quality of Drug Master Files. He also brought up the issue of user fees for generic drugs. Among the points he made:
- OGD's budget has doubled since 2001, staffing has increased and will rise again this year
- Since 1996, the average time for approval has dropped 40% to 16 months
- Sponsors should use the dissolution data posted on the Internet in their applications.
- Complete applications result in multiple review cycles. Last year, 93% of generic applications were rejected during the first cycle, and 59% during the second cycle.