Use of Citizen Petitions Questioned

Some lawmakers, FDA officials and generic pharmaceutical companies have begun to raise concerns that "citizen petitions" -- requests for agency action on scientific and safety issues that any individual, group or company can file -- "may be getting subverted" by brand-name pharmaceutical companies that seek to prevent generic competition, the Washington Post reports. According to the Post, critics maintain that the "simple act of filing a petition ... triggers another round of time-consuming and often redundant reviews of the generics by the FDA, which can take months or years."

Sens. Debbie Stabenow (D-Mich.) and Trent Lott (R-Miss.) earlier this year introduced a bill (S 2300) that would place restrictions on petitions filed by brand-name pharmaceutical companies. According to statistics compiled by Stabenow, FDA has rejected 20 of 21 petitions filed by brand-name pharmaceutical companies since 2003.

FDA currently has about 170 petitions under consideration, compared with 90 in 1999, and about 30% of those petitions involve challenges by brand-name pharmaceutical companies to applications to market generic medications, according to agency officials.

In a letter sent last month to acting FDA Commissioner Andrew von Eschenbach, Stabenow and Lott wrote that delays in the approval of an Impax application to market a generic version of the antidepressant Wellbutrin XL caused by a petition filed by manufacturer Biovail have cost consumers $37 million monthly. Biovail officials maintain that the company does not seek to prevent generic competition and that they have concerns about the bioequivalence and safety of the generic version of Wellbutrin XL Impax seeks to market.

However, according to Impax, "Biovail's petition is a sham, designed solely to delay the onset of generic competition for its Wellbutrin XL product."

Stabenow said, "The brand-name drug industry has found a major new loophole. 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 in profits from the delay."

Generic Pharmaceutical Association President Kathleen Jaeger said, "Because of the way the system works now, branded companies have every reason to file citizen petitions. There's a potentially great benefit, and there's no risk. I can't imagine that this is how the originators of the petitions thought they should work."

Scott Gottlieb, FDA deputy commissioner for medical and scientific affairs, in a recent interview said that the agency has made some changes to reduce review times for citizen petitions. Gottlieb said, "It's very hard to decide what's a blocking petition and what has value without taking a serious look. I think citizen petitions are very important and have to be preserved. The last thing we want to do is close off an avenue of discourse with the agency."

Pharmaceutical Research and Manufacturers of America Senior Vice President Caroline Leow said, "Most citizen petitions raise important regulatory, legal or scientific issues. The fact is, the petitions have played a vital role at the FDA since their adoption almost 30 years ago (Kaufman, Washington Post, 7/3).