[Generic-drug companies probably could’ve had PDUFA fees—and faster reviews of ANDAs—several years ago if all of the companies had been on the same page. Now, the FDA backlog has gotten so bad that they finally are.]
Generic drug industry leaders are lining up behind a proposal to pay user fees to the government as a way to speed approval of drugs and plant inspections, say several industry chiefs.
The heads of Mylan Inc. and Watson Pharmaceuticals Inc. said they are trying to break backlogs at the Food and Drug Administration, where copycat medicines now take an average of 2½ years to get approval[see #msg-59964880 re Copaxone ANDA].
At the annual gathering of the Generic Pharmaceutical Association this week in Orlando, Fla., industry chiefs hope to hammer out a unified plan in advance of negotiations over user fees that begin on Feb. 28 with the FDA.
Makers of branded drugs currently pay user fees to the FDA as part of a system to expedite drug approvals. Generic-drug makers don't pay the fees, and as recently as five years ago were looking for ways to block such a system for generics.
The meeting is being held as a number of blockbuster brand-name drugs are set to lose patent protection this year and next, opening the door to generic versions of medicines like Pfizer Inc.'s cholesterol fighter Lipitor.
"We must be able to move when those drugs come off patent," said Mylan President Heather Bresch.
Her sentiments were echoed by Paul Bisaro, chief executive of Watson, who said this is a "crucial moment" for the generics industry.
Generic drugs now make up nearly three-quarters of U.S. prescriptions[the highest penetration rate of any country] after rapid growth in recent years. The issue of lagging approvals is significant not only for the generic drug makers but also for consumers who count on competition from generics to drive down the price of widely used drugs.
Plant inspections are one of the main reasons for delays, because a generics maker cannot sell its products until the FDA certifies that its factory is following good manufacturing practices.
U.S. plants face inspections every two years or so, once they are certified, while foreign facilities may go years longer without an inspection. Ms. Bresch of Mylan, which has factories both in the U.S. and overseas, said it isn't fair for some facilities to face less oversight. "We need a level playing field," she said.
About 40% of the drugs in the U.S. are imported, an FDA official said last year.
The FDA has said the lack of funding for foreign inspections has hampered its inspection efforts, though the number of such visits increased in the wake of the crisis in 2008 over contaminated Chinese heparin.
A government report in 2010 said that about 64% of 3,700 foreign drug facilities may never have been inspected by the agency, and that the number of overseas inspections remains far lower than those done in the U.S.
Members of the generics association said the idea of a comprehensive plan including inspection and application fees has gained supporters.
The largest generic maker by sales, Teva Pharmaceutical Industries Ltd., rejoined the association in January after a policy rift, and will attend the conference.[Our good friend, Bill Marth, is a former president of GPhA.] This may boost the group's influence in talks with the FDA, members say. The FDA's commissioner is expected to address user fees in a speech in Orlando on Friday.
Since the 1990s, brand-name drug companies have paid user fees to speed their applications at the FDA.[These are so-called PDUFA fees, named after the Prescription Drug User Fee Act of 1997.]In exchange, the FDA promises to give an answer on new-drug applications according to fixed deadlines[but the “answer” is sometimes that the FDA needs more time, which makes a mockery of the process].
The Obama administration has supported user fees for generic drugs[#msg-59912094]. President Barack Obama's budget, released Monday, included $40 million in anticipated revenue from such fees in 2012. Any such plan would require approval from Congress.
An FDA senior policy adviser, Peter Beckerman, said the agency is open to the generics' comprehensive approach to setting up several fees. "We run a risk for inspections being a bottleneck," which keep generics from being ready to be sold the first day they are approved, he said.
Bob Billings, interim executive director of the generics association, said: "Our association is committed to advocating a holistic user-fee approach, one that will give FDA the funding for the resources it needs and one that holds FDA accountable for the results of how it spends those funds."‹
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