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Citizen Petition Preemption Of FDA Action Barred Under Proposed Rule

This article was originally published in The Tan Sheet

Executive Summary

Pending FDA actions cannot be the subject of a citizen petition submitted to the agency under a proposed rule published in the Nov. 30 Federal Register.

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FDA In Brief

NSA switch prospects: FDA is "working hard" on WellPoint's citizen petition to switch non-sedating antihistamines OTC, Office of the Chief Counsel General Attorney Seth Ray says during FDLI Annual Educational Conference in Washington, D.C. April 2. In response to a question about whether FDA is "actively considering" a forced switch of Aventis' Allegra and Pfizer's Zyrtec, Ray noted "I think that's a fair assumption." When asked about potential classes of Rx drugs FDA might look to switch OTC, CDER Deputy Director Steven Galson, MD, said "we really haven't identified any as [a] top priority that we're working on...there's nothing that we're about to launch and announce in this regard." FDA recently stated its intention to become more proactive in Rx-to-OTC switches (1"The Tan Sheet" Feb. 10, 2003, p. 3)...

OTC Drug Review Hindered By Citizen Petition Proposed Rule - CHPA

FDA's proposal to ban citizen petitions on pending regulations "appear[s] to preclude the introduction of new data and information in the OTC drug review," the Consumer Healthcare Products Association argues in Feb. 28 comments.

FDA citizen petition tentative replies should indicate agency position, IG says.

FDA CITIZEN PETITION TENTATIVE REPLIES SHOULD INDICATE POSITION as to whether the petition will be granted or denied, the HHS Inspector General recommends in a report reviewing the FDA citizen petition process. The report recommends the agency "include in all tentative responses to petitioners an estimate of when a final response will be issued and, to the extent possible, a preliminary indication of whether FDA will approve or deny the petition." The report was issued July 17.





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