A Citizen’s Petition And A Delayed Generic

For almost three years now, a mystery company has foiled Nastech Pharmaceutical’s hopes of bringing its first product to market. Known as Calcitonin, the med would provide patients who have postmenopausal osteoporosis with a generic alternative to Miacalcin, a nasal spray with nearly $145 million in sales last year, The Seattle Post-Intelligencer writes. It could also produce a much-needed boost for Nastech, which has been forced to cut its budget and lay off more than half its staff in the months since Procter & Gamble withdrew from a lucrative partnership.

The FDA agreed to review Nastech’s Calcitonin for approval in February 2004, three months after Nastech submitted its application. But an unnamed drugmaker, represented by an attorney who once worked for the FDA, challenged the application. The resulting standstill highlights the controversy over citizen’s petitions, even though the FDA argues the process for allowing generics to market is designed to be relatively quick. On average, it took about 16 months to get a generic product approved in 2005, but Nastech has now been waiting almost 50 months, the paper writes.

In September 2005, more than a year after Nastech applied to the FDA, David Rosen, an attorney at Foley & Lardner in Washington, DC, filed a citizen’s petition on behalf of a client, challenging Nastech’s application. In his letter, Rosen argued there was a possibility that the active ingredient in Miacalcin and Nastech’s product would not necessarily be the “same” because there could be contaminants in the production process, the paper explains. In July 2006, the FDA told Nastech its med was not approvable and cited a “potential for immunogenicity.”

Rosen tells the paper the client is a drugmaker, although a spokeswoman for the drugmaker with the most at stake - Novartis, which makes Miacalcin - denies involvement. “When people ask me to write things I believe in, I write them,” he tells the paper. “At the time when I wrote that citizen’s petition you didn’t have to disclose who was the client. They would rather keep that confidential.”

A trade group for generic makers maintains that brand-name drugmakers often file citizen’s petition on the eve of a generics application approval, which would slow the review. Legislation passed in September 2007 has changed much of the process. Under the FDA Amendments Act, the FDA now has to rule on a citizen’s petition within six months of its filing and whoever writes a petition must identify who pays them to do so.

Still, there are doubts about whether those rules are being followed. The paper notes that, in a letter addressed to FDA commish Andy von Eschenabach dated Wednesday, seven senators wrote: “Although the citizen petition provision has been in law for more than six months, it is unclear to us whether or to what extent FDA has taken steps to implement this provision. At a time when healthcare costs continue to increase exponentially, we cannot afford the added delay in the approval of lower-cost generic pharmaceuticals.”