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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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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)...

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)...

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)...

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