Makena Follows Avastin’s Path With US FDA Hearing On Accelerated Approval Withdrawal
Chief scientist Denise Hinton will decide the fate of Covis’ preterm birth prevention drug because acting commissioner Janet Woodcock has recused herself; CBER deputy director Celia Witten is tapped to serve as presiding officer at the hearing, which will be only the second of its kind under accelerated approval regulations.
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Company is not entitled to CDER's unredacted materials or predecisional drafts and emails on the proposed withdrawal of accelerated approval. However, presiding officer Celia Witten sets a 24 January deadline for CDER’s document production and requests the center re-examine what materials from a medical policy council meeting can be released.
Jacqueline O’Shaughnessy takes over as acting chief scientist following Denise Hinton’s move to the surgeon general’s office; Hinton previously had been tapped by acting commissioner Janet Woodcock to make a final decision on the accelerated approval status of Covis' preterm birth prevention drug Makena.
A new study highlights a subset of high-cost drugs in Medicaid for which legal and policy tools may be available to manage spending growth.