Michele To Lead FDA OTC Division Amid NSURE Uncertainty
This article was originally published in The Tan Sheet
Theresa Michele moves from CDER’s Division of Pulmonary, Allergy and Rheumatology Products to direct the Division of Nonprescription Clinical Evaluation.
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Rx-to-OTC switch sponsors should not wait for FDA to act on NSURE before proposing innovative switch solutions, because reviewers are open to discussing ideas now, an agency official says. Some experts predict the new switch paradigm will not yield concrete regulatory changes, and are promoting other ways to expand OTC access.
Andrea Leonard-Segal and Melissa Furness talked with “The Tan Sheet” about the evolving opportunities for Rx-to-OTC switch and the significance of recent switches. Leonard-Segal, the former director of FDA’s Division of Nonprescription Clinical Evaluation, and Furness, a former DNCE supervisory consumer safety officer, started a consultancy to offer guidance on OTC switch programs and other regulatory areas.
Merck’s Oxytrol for Women has the opportunity to “create the market” for OTC overactive bladder drugs, as well as encourage other switches for chronic, progressive conditions, marketing consultant Joe McGovern says. The transdermal patch product is slated to launch in September.