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

More from Drug Pricing

Celltrion Sees Multiple Biosimilar Opportunities From Trump’s Pricing EO

 
• By 

Biosimilars giant Celltrion tells shareholders there could be multiple opportunities for its business under US President Donald Trump’s latest executive order on drug pricing.

Strong Showing For Bayer’s Pharma Business In Uncertain Times

 
• By 

As CEO Anderson backs high prices for innovative drugs in Europe

Trump’s MFN Executive Order More Rhetoric Than Action

 

The details of Trump’s latest executive order on drug pricing are vague and the president put more blame on other countries and pharma distributors than drug companies.

Pharma Left Hanging After US/UK Trade Pact

 
• By 

An ‘historic economic prosperity deal’ does not include the sector.

More from Scrip

Strong Showing For Bayer’s Pharma Business In Uncertain Times

 
• By 

As CEO Anderson backs high prices for innovative drugs in Europe

Stock Watch: Stock Watch: Lilly And Novo Duke Out Q1

 
• By 

Novo Nordisk enjoyed a surprise GLP-1 agonist contracting win in the first quarter of 2025. This provided a welcome boost to its stock after it had spent the previous quarter on the back foot against rival Lilly.

Azafaros Banks Over €130m To Advance Nizubaglustat Into Phase III

 
• By 

The therapy has been developed for GM1 and GM2 gangliosidoses and Niemann-Pick disease type C.