By Kurt R. Karst –
FDA’s Office of Generic Drugs (“OGD”) has a backlog of Abbreviated New Drug Applications (“ANDAs”) that is nearing 2,000, according to OGD Director Gary Buehler, who presented the data at the recent Generic Pharmaceutical Association (“GPhA”) Annual Meeting. OGD’s median ANDA approval time was also up about 5 months – to 26.70 months – in Fiscal Year (“FY”) 2009 compared to the FY 2008 figure of 21.65 months. Both the ANDA backlog and median approval times have progressively increased over the past several years, while the numbers of ANDA receipts and approval actions have remained relatively steady, as illustrated in the tables below from Mr. Buehler’s GPhA presentation.
So why such a ANDA backlog and rising median approval times? The answer lies in OGD’s resources, according to FDA Commissioner Dr. Margaret Hamburg. In Her speech at the GPhA Annual Meeting, Dr. Hamburg commented that “no one benefits from a pending-application queue that will soon hit the 2,000 mark. This is simply unacceptable. . . . But the unprecedented spike in generics applications has simply outstripped our capacity to properly review, which must remain our foremost focus. The solution lies in resources.” (emphasis in original)
And “resources” means both funding from Congress and the generic drug industry, according to Dr. Hamburg:
We have already begun to use the $10 million that Congress allotted to our agency to hire 50 additional scientists to address the generics-application backlog. But without action from your industry, too—without your support for a fair system of user fees—we simply cannot achieve for the public what we otherwise could. . . . We very much want to work with you to see generic drug user fees enacted this year. Adequate and reasonable fees will be key to both more rapid review and to better surveillance.
The President’s FY 2011 budget request for the Department of Health and Human Services includes $51,545,000 in appropriations to OGD (a $10 million increase over last year) and proposes “user fees to support activities related to generic human drug reviews” (as well as new user fees for re-inspections of FDA-regulated facilities). Contingent upon the enactment of authorizing legislation, generic drug user fees would be expected to bring in an amount not to exceed $38,015,000.
According to FDA’s FY 2011 Congressional Justification, generic drug user fees would more than halve the current median approval time:
FDA will hire additional staff to support the review of [ANDAs] for generic drugs and inspections of generic drug manufacturing facilities. In the case of user fees, by the end of the first five years of the Generic Drug User Fee Program, the additional user fees will result in a complete review and response for an estimated 80 percent of applications within 12 months of receipt, other than applications excluded because of exclusivity or challenges.
Previous budget requests have proposed the establishment of generic drug user fees (along with draft performance goals); however, legislation has never gotten off the ground and negotiations between FDA and GPhA were stalled, apparently over what FDA’s performance results should be.
Dr. Hamburg expressed her hope that interested parties “can return to the negotiating table soon.” GPhA appears to be open to reengaging FDA in user fee negotiations, according to a GPhA press release.