Big Pharma vs generics - widening the "citizen petition" loophole

Big Pharma companies are fighting for their very existence.

Their pipelines are dry.

New blockbusters are twice as rare as their old ones, which are ending their patent lives over the next five years or so.

So the gloves have come off and they are finding every legal loophole that allows them to squeeze every last penny out of their existing product portfolio.

Take Biovail, for example.

The Washington Post reports:

When its hot-selling antidepressant Wellbutrin XL was facing the prospect of competition from cheaper generics late last year, Biovail Corp. filed a "citizen petition" with the Food and Drug Administration, raising concerns about the safety of its potential rivals.

Impax Laboratories Inc. and several other companies had already gone through much of the FDA application and review process for their generic versions of the drug, and Impax was looking forward to getting a tentative approval that would bring it considerably closer to making and selling its competing drug.

But because of the citizen petition -- a request for agency action that any individual, group or company can file -- the FDA has yet to act, and Biovail still has the market for Wellbutrin XL to itself.

Impax is fuming, as are many others in the generic drug industry.

"Biovail's petition is a sham, designed solely to delay the onset of generic competition for its Wellbutrin XL product," Impax told the FDA in a letter. "Biovail has wasted FDA's and Impax's time and resources and has likely cost the American public millions of dollars in taxes and health care expenditures in selfish pursuit of further undeserved windfall profits."

Although citizen petitions have raised many important drug policy issues, the Wellbutrin filing is one of several dozen pending that some call "blocking petitions" because they have the effect of delaying approval of a generic alternative. FDA officials said that about 170 citizen petitions are before the agency -- compared with 90 in 1999 -- and that about 30 percent involve industry challenges to generic applications.

FDA Chief Counsel Sheldon Bradshaw told generic drugmakers at a September conference that the agency has been troubled by the number of such petitions. He said they "appear designed not to raise timely concerns with respect to the legality or scientific soundness of approving a drug application, but rather to delay approval by compelling the agency" to review arguments that could have been made months before.

Read all about it here.