FDA clears more generic drugs

By Kim Dixon

WASHINGTON (Reuters) - The U.S. Food and Drug Administration on Thursday said it approved one-third more generic drugs last fiscal year and said it planned to speed review of these cheaper versions of brand-name drugs.

Officials said the push includes an expedited review process using an updated electronic format and team reviews of multiple applications for the same product.

The FDA said it approved a record 682 generic drugs in fiscal-year 2007 ended last week and faces a backlog of 1,300 applications, up from about 800 about a year ago.

"These applications represent a vast scope of products -- and over half are still protected by patents. There is no way we could approve all of these applications," Gary Buehler, FDA director for generic drugs, told reporters on a conference call.

"We had no anticipation that the number of generic applications would skyrocket as it did" in the past several years, he added.

Generic prescription sales rose 22 percent from 2005 to 2006, according to the nonprofit Kaiser Family Foundation, as blockbuster drugs lost patent protection and health-care payers sought to cut costs.

The average brand name drug prescription price was more than three times the average generic drug price in 2006, Kaiser says.

The Generic Pharmaceutical Association, which represents most of the industry, called the generic review effort weak.