July 5, 2006

The FDA may not be doing all it can to ensure timely approval of generics and prevent brand companies from exploiting the citizen petition process to delay competition, according to two members of the U.S. Senate.

In a letter to acting FDA Commissioner Andrew von Eschenbach, Sens. Debbie Stabenow (D-Mich.) and Trent Lott (R-Miss.) accused brand companies of purposely filing "frivolous" citizen petitions in order to put off FDA approval of generic companies abbreviated new drug applications (ANDAs). FDA review of a petition and the resulting delay can extend a brand company's monopoly on a drug from several months to more than two years, they wrote.

The letter cites a speech given last year by the FDA's chief counsel that stated that the agency has seen citizen petitions that it believed were submitted only for the purpose of forcing the FDA to review the arguments, regardless of the merits or the fact that the petitions could have been submitted much earlier.

One example in the letter is the generic version of Arava, which was held up for six months because of a brand company's petition submitted just before the ANDA was to be approved. The FDA denied the petition, but only after consumers paid an extra $110 million, the letter said.

"At a time when healthcare costs continue to increase exponentially, we cannot afford the added delay in the approval of lower-cost generic pharmaceuticals," the senators wrote. "These abusive petitions are strategically timed to delay generic competition, and as such are effectively creating a free patent term extension for the brand companies without any congressional oversight or approval." (http://www.fdanews.com/did/5_130/)