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FDA’s Califf Speaks Of Tailoring Trials For CMS Evidence Amid Spotlight On Alzheimer’s Drugs

 
• By Vibha Ravi

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.

US FDA Vector Representation
US FDA Commissioner Robert Califf discussed the value of federated data. • Source: Shutterstock

FDA Commissioner Robert Califf’s remarks at the recent USA-India Chamber of Commerce (USAIC) Annual Biopharma and Healthcare Summit were a reminder that while the head of the agency has been a physician in the modern era, he is also increasingly expected to be a diplomat as well – smoothing relations between payers and developers as well as between the US and the countries that it relies on for data on and manufacturing of products.

For example, divergent actions by the US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) on monoclonal antibodies that target amyloid for the treatment...

Key Takeaways

  • “Baton handoff” to CMS would work better if US FDA could tailor trials to begin to generate the evidence the former needs.

  • ...

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