Monday, April 10, 2006

FDA backlog = Billions for Big Pharma?

A bottleneck of generic drug applications may give branded drugs more time on the market without generic competition.

good thing if you own big pharma stock...

NEW YORK ( - Big Pharma could land billions of dollars in annual sales that it would have lost to generic competitors thanks to a Food and Drug Administration backlog of applications for generic drugs.

Some $100 billion worth of branded drugs are expected to go off patent over the next five years. In theory, this should translate into lost revenue for branded drug companies because they would face a plunge in sales as they compete with low-cost generic versions of their drugs.

But the FDA's Office of Generic Drugs, which reviews applications for generic drugs, faces a bottleneck of some 800 applications. This is the result of a 36 percent surge in applications last year, according to the Generic Pharmaceutical Association, citing statements made by Gary Buehler, director of the Office of Generic Drugs, at a GPhA conference in February.

"Over the next few years, it's really going to be a problem, as more drugs go off patent," said GPhA spokeswoman Andrea Hofelich.

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