FDAnews Drug Daily Bulletin

Citizen Petition Reforms Under Revised PDUFA to Have Limited Impact

Sept. 17, 2007

Language in the FDA Revitalization Act (FDARA) intended to limit the use of citizen petitions to block approvals of generic drugs will not likely curb the use of the practice, according to Richard Silver, senior vice president of Equity Research for Lehman Brothers. FDARA would reauthorize the Prescription Drug User Fee Act (PDUFA).

“Citizen’s petitions … we do not think they’re going to go away. The backlog continues to grow,” Silver said last week during the Generic Pharmaceutical Association’s Annual Policy Conference in Washington, D.C. “We don’t think the citizen’s reforms will change the behavior of brand companies significantly.”

Two versions of the legislation, S. 1082 and H.R. 2900, are currently pending before a conference committee. Conferees have not been appointed to reconcile the two versions of the bill.

S. 1082 prohibits the FDA from delaying approval of a generic drug on the basis of a citizen’s petition unless such a delay is necessary to protect the public health, according to a summary of the bill. In addition, it requires the FDA to take final action on a petition no later than 180 days after its submission unless such a delay is necessary.

The use of citizen petitions has been an effective tactic in delaying generic entrants to the market. For example, Wyeth’s injectable antibiotic Zosyn (piperacillin/tazobactam) reached blockbuster status earlier this year despite being off-patent. The FDA has not approved any abbreviated new drug applications referencing the product due in part to a citizen’s petition filed by the company last year.