CHIEF COUNSEL BRADSHAW: CITIZEN PETITION PROCESS REQUIRES REFORM

The FDA's chief counsel wants to reform the citizen petition process to discourage brand drugmakers from filing petitions simply to delay generic drug debuts.

Speaking at the first annual conference of the Generic Pharmaceutical Association in Washington, D.C., the FDA's chief counsel, Sheldon Bradshaw, said he wants to prevent applications from "getting unnecessarily waylaid by these sorts of tactics," and invited generic drug industry representatives to offer their suggestions.

One solution, Bradshaw said, would be putting citizen petitions and abbreviated new drug applications (ANDAs) on "different tracks," so filing a citizen petition won't automatically delay approval of an ANDA as it does now.

The generics industry has criticized the FDA's citizen petition process for years, saying that brand firms, with patents due to expire, often file multiple petitions with the FDA for the sole purpose of delaying the entry of generic competition.

Bradshaw said he feels conflicted over the issue because on one hand he wants all sides to be able to weigh in but that he has "seen firsthand that many of these petitions seem totally without merit."