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.
You may also be interested in...
Scrip examines Torrent Pharma and Strides Pharma’s divergent strategies and Q4 financial performance in the US and India while presenting an infographic to compare market-wise metrics
Lack of detail on data elements that would be required through the portal has stakeholders wondering if the Centers for Medicare and Medicaid Services has really found a way to make the registry requirement less of a threat to access for Alzheimer’s drugs with traditional FDA approval.
FDA Commissioner Robert Califf spoke of the need for a better hand-off to CMS, including tailoring trials to generate evidence relevant for Medicare coverage. He also weighed in on the possibility of accelerated approval for chronic disease drugs, among other topics.