U.S. FDA Aspires To Speed Generic Drugs To Market

FDAWashington: The USFDA sanctioned one-third more generic drugs last year and said it has planned to quicken assessment of these cheaper editions of branded drugs.

Functionaries stated that the thrust consists of an expedited review process using an updated electronic format and team reviews of multiple applications for the same product.

The FDA said it has given nod to a record 682 generic drugs in fiscal year 2007 finished last week and confronts a backlog of 1,300 applications, up from around 800, a year ago.

Gary Buehler, FDA director for generic drugs said, “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.”

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

The generic drugs utilization has significantly increased in recent years, as blockbuster drugs lose patent protection and healthcare costs increase.

The Generic Pharmaceutical Association that represents the majority of the business industry, called the generic review effort weak.

The group wishes restrictions on the practice of trade-name drug manufacturers requesting the group to end generic applications that holds up approval times considerably. The group also called for more resources, not part of the FDA’s plans.

Kathleen Jaeger, president of the group, said, “Another initiative in name only simply will not get the job done.”

“For years, the agency has tinkered around the edges with programs and initiatives designed to increase efficiency but have proven to yield little in the way of significant results.”

The group said it might obtain additional resources under a request now before the U.S. Congress, but its plans are based on its existing funds and staff.

The agency stated that it obtained 880 generic applications in fiscal year 2007, as compared to 792 applications in fiscal year 2006.

Unlike their trade name counterparts, generic drug companies do not pay user-fees to aid fund review of applications. The industry defends the charges.

Top generic drug manufacturers including Teva Pharmaceutical Industries Ltd, Mylan Laboratories Inc, Barr Pharmaceuticals Inc, Watson Pharmaceuticals Inc, and Novartis AG’s Sandoz unit.

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