Generic drug backlog to spike: FDA official

By Susan Heavey and Lisa Richwine

ROCKVILLE, Maryland (Reuters) - The backlog of pending generic drug applications is likely to top 1,500 this year and climb further unless the U.S. Food and Drug Administration receives more funding, a top agency official told Reuters on Wednesday.

The time it takes agency reviewers to evaluate proposed generic drugs rose to a median of nearly 19 months in fiscal year 2007, from nearly 17 months in 2006, Gary Buehler, director of the FDA's Office of Generic Drugs, said in an interview.

Applications seeking permission to sell cheaper copycat versions of medicines have swelled in the last five years, Buehler said. The FDA has struggled to sift through the surge of new requests that come as a number of blockbuster medications are losing patent protection.

The market is gearing up for a "patent cliff" that will see some of the world's most lucrative medicines lose protection from 2010 to 2012, clearing the way for generic rivals.

Merck & Co Inc's cholesterol-fighting drug Zocor recently began facing generic competition as has Pfizer Inc's blood-pressure drug Norvasc. Other big brands, including Pfizer's cholesterol drug Lipitor and various antidepressants, among others, also will face copycats in the next decade.

Generic drugmakers include Teva Pharmaceutical Industries Ltd, Mylan Inc and Ranbaxy Laboratories Ltd. Watson Pharmaceuticals Inc, Novartis AG's Sandoz unit and Barr Pharmaceuticals Inc, which Teva is seeking to buy, also are large generic drugmakers.

While the FDA has taken steps to streamline its review process, the backlog has nearly tripled since the early 2000s, Buehler said. In fiscal year 2007, 1,344 generics had decisions pending compared to 515 in 2003. As of late May, it had grown to 1,480. The fiscal year ends in September.

"We still have not been able to catch up with the increase in submissions," he said. "We're very aware that people are waiting for the products."

More funding would help, Buehler said, and although Congress has given the office more money to hire reviewers it is not enough. The FDA has asked the generic industry to start paying fees to help speed reviews but has not reached an agreement with the companies.

Brand-name drugmakers and device companies already pay review fees.

(Additional reporting by Lewis Krauskopf; Editing by Tim Dobbyn and Carol Bishopric)