Editorial: Petitions bound by red tape

Wednesday, July 5, 2006 | 7:18 a.m.

Brand-name drug makers have long concocted creative methods of thwarting generic competition, so their latest strategy should come as no surprise.

The latest tactic amounts to a fairly simple manipulation of Food and Drug Administration rules. Agency procedures allow for something called a "citizen petition," which can be filed by virtually anyone, an organization - or a company.

The petition is a formal request that the FDA conduct one last drug review, often a time-consuming, costly and redundant one, according to The Washington Post. It seems that some brand-name drug manufacturers use this petition to put the brakes on rivals that are preparing to sell generic drugs - a delay that allows the brand-name manufacturers to continue reaping millions as their higher-priced drugs don't receive competition from the less-expensive generic drugs.

The scheme has inflamed generic drug makers and captured the attention of Congress. Sens. Debbie Stabenow, D-Mich., and Trent Lott, R-Miss., in February unveiled a bill to close what Stabenow called the "patent loophole."

The lawmakers have noted that Biovail Corp., maker of the antidepressant Wellbutrin XL, used a citizen petition to delay the market debut of generic alternatives - and squeeze an estimated $37 million more a month out of consumers.

Drug companies claim they are filing the petitions to better protect the public. That's disingenuous. The FDA eventually rejected 20 of the 21 petitions filed by the industry since 2003, according to Stabenow's office.

The FDA's complex rules were written to protect the public from unsafe drugs. But who will protect the public from drug companies gaming the regulatory system? Congress should. The companies are - quite legally - hurting consumers, so Stabenow and Lott have the right idea.

Lawmakers ought to craft legislation that preserves warranted final drug reviews, but also blocks brand-name drug companies from filing citizen petitions for the single purpose of making more money.