FDA chief urges generic drugmakers’ help in avoiding bottlenecks

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.”