Petitions to FDA Sometimes Delay Generic Drugs

By Marc Kaufman
Washington Post Staff Writer
Monday, July 3, 2006

A procedure designed to alert the Food and Drug Administration to scientific and safety issues is getting a hard look from members of Congress, who say they are concerned that it may be getting subverted by the brand-name drug industry.

Some at the FDA, as well as leaders in the generic drug industry, complain that "citizen petitions" -- requests for agency action that any individual, group or company can file -- are being misused by brand-name drugmakers to stave off generic competition.

The simple act of filing a petition, they say, triggers another round of time-consuming and often redundant reviews of the generics by the FDA, which can take months or years. In the process, consumers continue to pay millions of dollars more for the brand-name drugs.

Statistics collected by the staff of Sen. Debbie Stabenow (D-Mich.), who has introduced legislation with Sen. Trent Lott (R-Miss.) that would rein in industry-filed citizen petitions, show that 20 of the 21 brand-name petitions settled by the FDA since 2003 were ultimately rejected.

"The brand-name drug industry has found a major new loophole," Stabenow said in an interview. "The way things stand now, even if the FDA finds that a petition was frivolous and rejects it, [the drug companies] can get hundreds of millions of dollars of profits from the delay."

She and others point to the example of Wellbutrin XL, a hot-selling antidepressant that was facing the prospect of competition from cheaper generics late last year.

By the time Biovail Corp., the drug's maker, filed a citizen petition with the FDA, 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. 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, 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.

In a letter sent last week to FDA Acting Commissioner Andrew von Eschenbach, Stabenow and Lott estimated that the delay in approving a generic version of the antidepressant Wellbutrin XL is costing consumers $37 million a month.

Impax already sells a twice-a-day version of Wellbutrin; the once-a-day XL version was approved by the FDA in 2003 as the patent on the shorter-lasting formulations was running out.

"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."

Biovail rejects the view that it is trying to block generic competition, and in its petition made the case that generic versions of its product may not be biologically equivalent and could be dangerous. As a result, the company -- which has also filed patent infringement suits against its prospective rivals -- asked the FDA to require substantial additional testing before any generic version of Wellbutrin XL is approved.

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