FDA’s Califf Defends CMS Drug Coverage Role, Blames Rx Industry Prices For US Health Woes

US FDA Commissioner defends role of his sister-agency CMS in determining drug coverage after his agency’s approvals. Califf weighs in on a variety of drug pricing topics – including the IRA, accelerated approval pricing, and obesity drug coverage – at the annual BIO meeting in Boston.

BIO CEO Rachel King interviewed FDA Commissioner Robert Califf on 7 June 2023 at the BIO International Convention in Boston
BIO CEO Rachel King interviewed FDA Commissioner Robert Califf on 7 June. • Source: Sarah Karlin

From Alzheimer’s drug coverage to the implementation of government drug price negotiations in the Inflation Reduction Act, the pharmaceutical industry’s frustration with the US Centers for Medicare and Medicaid Services has rarely been higher. But if pharma was looking for an ally in US Food and Drug Administration Commissioner Robert Califf, they appear to be mostly out of luck.

During a 7 June talk at the BIO International Convention in Boston, Califf defended the jurisdiction of his sister agency to control access to drugs after FDA approval and endorsed the idea that drugs granted accelerated approval

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