FDA chief urges generic drugmakers' help in avoiding bottlenecks

The head of the Food and Drug Administration on Friday told generic drugmakers that the agency is in a "critical time" as dwindling resources and growing demands threaten to delay approval of their products.

FDA Commissioner Margaret Hamburg used her keynote address at the annual conference of the Generic Pharmaceutical Association (GPhA) to urge generic drugmakers to work with her agency as it develops industry user fees that will ensure generics can quickly be reviewed and approved for sale. The FDA is currently seeking to create new fees that will enable generic and biosimilar drugmakers to directly pay the agency instead of relying on annual congressional appropriations.

House Republicans' stopgap budget bill for the rest of the year would cut the FDA budget by $220 million.

"Our resources are already stretched too thin," Hamburg said. "Looking ahead, it's clear FDA will not be able to make ends meet with our current resourcing, and more approvals will be delayed because of a lack of inspectional resources. That's why it's so important that this year — right now — we begin to constructively address the generic drug user fee issue."

The president's proposed budget for 2012 contains $40 million in anticipated revenues from the new fees, which are still being negotiated.

The GPhA favors the fees, but some consumer groups say they create an unhealthy FDA reliance on industry.

"GPhA has long supported a workable and meaningful generic drug user fee program," the trade group said in a statement Monday. "This means implementing a holistic program with appropriate performance goals to assure the timely approval of generic drugs. The Office of Generic Drugs cannot keep pace with its workload without additional resources. GPhA is delighted that the president included generic drug user fees in his budget request and we are anxious to work with the Agency to make user fees a reality."

Hamburg also said the FDA is improving communications with drugmakers and clarifying the type of information it needs to review and approve generics.

And she assured the group that FDA hopes to hire a permanent director for its Office of Generic Drugs this year. The director since 2000, Gary Buehler, was moved to the Office of Pharmaceutical Science last March shortly after Hamburg publicly complained of a growing backlog of generic drug approvals.

In an unusually frank assessment, Hamburg questioned whether the administration will be able to reduce the market exclusivity period for biosimilars from 12 years to seven. Doing so would raise $2.3 billion for a two-year "doc fix" that would postpone scheduled cuts in Medicare payments to doctors, she said.

"Who knows what will actually happen with this legislative proposal," Hamburg said. "It's still way too early in this new Congress for me to want to make any predictions."