1. Pink Sheet
  2. >>Market Access
  3. >>Pricing Debate

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

 
• By Sarah Karlin-Smith

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

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Pricing Debate

HHS Negotiating With Manufacturers On Most Favored Nation Drug Pricing

 
• By Cathy Kelly

MFN policy would would apply to all single source drugs in all insurance markets, according to HHS release. Secretary Robert F. Kennedy Jr. said the department is discussing the plan with drug sponsors.

‘Tectonic’ Arkansas PBM Legislation May Upend Industry

 
• By Tim Casey

Industry will fight hard to prevent other states or the federal government from adopting measures similar to Arkansas' law preventing PBMs from owning pharmacies.

Will International Prices Influence Medicare Price Negotiation?

 
• By Cathy Kelly

A former CMS official suggested the most likely way it could happen is through a Center for Medicare and Medicaid Innovation demonstration.

Industry Leaders Grapple With Trump’s Most Favored Nation Pricing Plan

 
• By Jessica Merrill

At the Bank of America health care conference, pharma leaders speculated on the impact of Trump’s most favored nation pricing executive order on US and European markets.

More from Market Access

‘Tectonic’ Arkansas PBM Legislation May Upend Industry

 
• By Tim Casey

Industry will fight hard to prevent other states or the federal government from adopting measures similar to Arkansas' law preventing PBMs from owning pharmacies.

Will International Prices Influence Medicare Price Negotiation?

 
• By Cathy Kelly

A former CMS official suggested the most likely way it could happen is through a Center for Medicare and Medicaid Innovation demonstration.

Managed Access Agreement Fails To Help BioMarin’s Brineura Secure Routine Reimbursement In England

 
• By Francesca Bruce

BioMarin’s ultra-rare disease drug Brineura has breached cost-effectiveness thresholds for highly specialized treatments in England and looks set to be denied routine funding on the National Health Service.