The outcome of the October 2022 public hearing on the FDA Center for Drug Evaluation and Research’s proposal to withdraw Covis Pharma’s Makena was negatively influenced by hearing officer Celia Witten’s framing of the last voting question, the company asserts.
Covis said the Obstetrics, Reproductive and Urologic Drugs Advisory Committee (ORUDAC) “was influenced by the ad hoc narrowing” of the final voting question “such that it