Accelerated Approval Reform Target? Makena Hearing Highlights Product Promotion During Withdrawal Period
Makena hearing and the product’s prolonged withdrawal process raises questions about whether FDA needs new authorities to curtail advertisement and ensure accurate patient and provider education after an accelerated approval drug’s confirmatory trial fails and/or during the period in which the agency is considering pulling the product from the market.
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Ahead of the final withdrawal decision, FDA terminated internal separation of functions so that the Office of the Commissioner and CDER could coordinate next steps; Makena’s NDA approval has been withdrawn, but the product’s website lives on, albeit with a pop-up window explaining the regulatory action.
Lengthy withdrawal process creates an opening for the FDA to better convey its concerns about a medicine’s benefit-risk profile in a way that impacts prescribing guidelines, Johns Hopkins’ Joshua Sharfstein says; CDER’s Jacqueline Corrigan-Curay says new expedited withdrawal procedures under omnibus law appear more ‘streamlined’ than those followed for Makena.
The American College of Obstetricians and Gynecologists and Society for Maternal-Fetal Medicine did not testify at the public hearing on CDER’s proposal to withdraw the preterm birth prevention drug, even though the groups’ clinical guidelines still recommend use of Makena and its active ingredient.