FDA OFFICIAL RECOMMENDS MAKENA WITHDRAWAL— The FDA official who presided over the agency’s October meeting when it advocated pulling a preterm birth drug from the market has issued a memo agreeing with the proposal. In a document posted online Friday, Celia Witten, deputy director of the FDA’s Center for Biologics Evaluation and Research, summarized the meeting’s discussion and included her own recommendation that regulators withdraw its approval of Makena, marketed to help prevent preterm birth, more than a decade after it was green-lit for consumers on an accelerated basis. Witten agreed with members of the agency’s obstetrics and reproductive drugs advisory committee that the drug hasn’t proven effective in either a broad or a narrower population proposed by maker Covis, and that known and suspected safety concerns are enough to tip the balance in favor of withdrawal. “I do not think there is a favorable benefit-risk profile to support Makena’s remaining on the market and recommend approval be withdrawn,” she wrote. “There is equipoise for a new study, which I hope will be feasible to conduct.” What’s next: Covis and the FDA’s drug office have until March 6 to respond to Witten’s report. Commissioner Robert Califf and the agency’s chief scientist will consider any submissions in making the final decision on the withdrawal proposal. BIDEN URGES HHS, DHS TO ISSUE MEDICATION ABORTION GUIDANCE — President Joe Biden signed a memorandum over the weekend directing HHS and the Department of Homeland Security to consider new guidance “to support patients, providers, and pharmacies who wish to legally access, prescribe, or provide mifepristone” — a key drug used in medication abortion — “no matter where they live.” The memo also encourages the agencies to consider actions “to educate individuals on their ability to seek legal reproductive care, free from threats or violence.” It comes as states with abortion restrictions — particularly before 10 weeks of pregnancy, which is when mifepristone is indicated for — hit back at the FDA’s move earlier this month to allow corner-store pharmacies to dispense the drug for the first time. FDA: ORPHAN DRUG APPROACH STAYING THE SAME — The FDA announced Monday it intends to continue to tie orphan-drug exclusivity to indications approved by the agency instead of an entire disease area. The decision follows a ruling by the Court of Appeals for the Eleventh Circuit that the orphan-drug exclusivity for the FDA’s approval of Catalyst Pharmaceuticals’ drug in November 2018 for the treatment of Lambert-Eaton myasthenic syndrome, a rare autoimmune disease, in adults blocks the agency from approving other firms’ drugs for other LEMS indications. In May 2019, the agency approved a drug from Jacobus for the treatment of LEMS in children — a decision that Catalyst sued over in June 2019. As a result of the circuit court ruling, the FDA set aside the approval of Jacobus’ LEMS drug. The agency argues its interpretation of the orphan drug exclusivity law “best advances” the balance of incentivizing rare disease drug development and ensuring patients — especially children — have access to orphan drugs. “FDA continues to believe that the statutory text does not unambiguously require that orphan-drug exclusivity extend to the entire disease or condition for which a drug received orphan-drug designation if the drug is only approved for some uses within that disease or condition,” Lauren Roth, FDA associate commissioner for policy, wrote in a notice published in the Federal Register on Monday.
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