FDA’s Plan B Decision To Be Guided By Public Comments, Deputy Commissioner Says
This article was originally published in The Pink Sheet Daily
Executive Summary
The agency is awaiting comments about the “legal authority and regulatory pathway” for marketing an active ingredient both as a prescription and OTC drug, Deputy Commissioner Gottlieb says.
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FDA's handling of Barr's application to switch the emergency contraceptive Plan B to over-the-counter status will be guided by public comments received by the agency, Deputy Commissioner for Medical & Scientific Affairs Scott Gottlieb said Sept. 28. "It really depends on what we learn in the comment period, because we asked some fundamental questions about legal authority and about regulatory pathway," Gottlieb said during a speech at the National Press Club in Washington, D.C. "There will probably be some people who think we do and don't have the legal authority to accommodate different kinds of options," he added. On Aug. 26, FDA announced it would issue a notice of proposed rulemaking to collect comments on "unresolved legal and policy issues" affecting Barr's application. Barr is seeking to make the drug available over-the-counter for women 16 and older, but prescription-only for women under 16. FDA is seeking comments on the circumstances under which an active ingredient can be marketed both as an OTC and prescription product (1 (Also see "FDA “Unable” To Decide On Plan B, Seeks Comment On Dual-Status Drugs" - Pink Sheet, 26 Aug, 2005.)). The decision to pursue the rulemaking process delayed further FDA action on Barr's Rx-to-OTC switch application. FDA's announcement prompted criticism from members of Congress, academia and the agency's own staffers; Office of Women's Health Director Susan Wood resigned in protest. One month after the Plan B delay was announced, Lester Crawford resigned as FDA commissioner (2 (Also see "Crawford Resigns; NCI Director Von Eschenbach Named To Top FDA Spot" - Pink Sheet, 23 Sep, 2005.)). Gottlieb said that the approach FDA took on Plan B was "Crawford's decision, and I understand why he reached the decision." The application "created fundamental questions about whether or not they could have the same molecule in the marketplace, the same indication, the same use, the same dosage, in the same packaging. We've never done that before." "That doesn't mean it's not something that we can pursue, but whether or not we can do an open public comment rulemaking is the question," Gottlieb said. Gottlieb noted that he has not yet talked to Acting Commissioner Andrew von Eschenbach about Barr's application. However, because the rulemaking process has begun, von Eschenbach will not be overseeing a traditional review. "I can't think of anything else that's going to happen between now" and the end of the comment period, Gottlieb said. Comments are due by Nov. 1. - Kathleen Michael |