Gottlieb Places Drug Pricing Out Front In First Speech To US FDA Staff
New FDA Commissioner tells employees that 'too many consumers are priced out of medicines they need' and that FDA must take meaningful steps to get lower cost alternatives to market.
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Supplemental Filings: FDA-CMS Collaboration, Beyfortus Approved For Pediatric RSV, Gavreto Loses An Indication, Sanders' Biosimilar Auto-Interchangeability Bill
CDER Director Cavazzoni has her description of CMS’ mandate corrected, the FDA approves AstraZeneca/Sanofi's nirsevimab but requires safety studies on RSV variants, Genentech and Blueprint Medicines withdraw Gavreto's medullary thyroid cancer claim due to confirmatory trial feasibility issues, and Bernie Sanders goes bold on biosimilars.
The FDA was mum on the expertise that it appears to be lending the payer, but Commissioner Robert Califf reiterated that communication between the agency and CMS is increasing.
The US FDA often reminds advisory committees that price is not part of its mission, but the agency pointedly told the experts meeting to review Lilly/Innovent’s sintilimab that “competition” should not be a factor either. Do they really mean that?