FDA Creates Express Lane for Approving Some Generic Drugs

From Reuters

The Food and Drug Administration will accelerate its reviews of certain generic drugs, a top agency official said Wednesday, a move the industry said could help get some cheaper alternatives on the market sooner.

Companies will be given priority if their application is the first one proposing a generic version of a brand-name drug that is no longer protected by a patent or market exclusivity, said Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research.

Applications filed before a patent or exclusivity ends will not be eligible under the new procedures, which have already been implemented.

Generic medicines that would address a public health emergency or nationwide shortage will also see faster reviews, he said. "We recognize that there are certain situations under which it is advantageous to public health to expedite certain applications," Galson said.

The FDA has a backlog of more than 800 generic drugs awaiting approval under the current process that evaluates all applications in the order it receives them. In 2005, the median time for an approval was more than 16 months, according to the FDA.

Last year, the FDA received 766 generic applications, the agency said. About 40 applications a year are for those that, if approved, would be the first generic alternative to a branded drug. The cause of the backlog is a lack of staff and funding, the FDA and others have said. Reviews for brand-name drugs are funded in part by company fees, but the FDA's work on generic bids is funded solely by the government.

"The resource constraints combined with an increased workload in the generics program is a double whammy," Galson said. "Particularly in this era of tremendous importance of saving healthcare dollars, we just can't fall behind."

Generic Pharmaceutical Assn. President and Chief Executive Kathleen Jaeger welcomed the priority reviews as a way to help patients and save the U.S. healthcare system millions of dollars. "This action will mean that consumers will have more timely access to safe, effective and affordable generic medicines," said Jaeger, whose group represents companies with a combined $22.3 billion in annual U.S. sales.

FDA officials have suggested that generic drug makers also pay fees to have their applications reviewed. An internal FDA working group is looking at whether such fees for generic companies would be feasible. The issue is likely to stir debate as Congress prepares to address agency funding next year.

Critics say the fees, also paid by medical device makers, compel the FDA to act in the interests of companies rather than patients and can lead to hasty approvals.

The generic-drug industry has urged greater funding from Congress.

At an industry conference, Jaeger said a number of other issues were slowing generic-drug approvals, including citizen petitions filed with the FDA by brand-name companies seeking to keep a generic medicine from the market.

"User fees simply won't speed up generic drug approval times if brand companies are still able to use loopholes such as citizen petitions to block consumer access to affordable generics," she said.

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