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Former FDA Chief Cites 5 Things To Watch On Drug Approvals

News  |  By Kaiser Health News  
   February 14, 2017

Robert Califf, MD, who stepped down last month, shared his thoughts about keeping Americans safe — and making sure drugs actually work — after about a year overseeing the federal agency.

This article first appeared February 14, 2017 on Kaiser Health News.

By Sydney Lupkin and Sarah Jane Tribble

The just-departed commissioner of the Food and Drug Administration has concerns about plans to speed up drug approvals and dramatically reduce regulations at the agency, as advocated recently by President Donald Trump.

Dr. Robert Califf, who stepped down last month, shared his thoughts about keeping Americans safe — and making sure drugs actually work — after about a year overseeing the federal agency. His takeaways:

1. Faster drug approvals, being advocated by Trump and others, don't necessarily mean less expensive drugs.

"What I'm concerned about is that when people hear 'faster approval,' you get an image of the FDA sitting on this application and, you know, twiddling thumbs," Califf said. "That's not what happens."

Califf explained that the slow part of getting a drug into patients' hands happens well before the drugmaker submits an application to the FDA. It can take decades to discover, tweak and test a new drug molecule, and that development process is what needs a boost.

"The real action [happens] before the application gets submitted and that can be a time frame from years to decades as people try to figure out what will work and what will not," Califf said.

Although faster drug development could bring development costs down, Califf said, "There's not a direct relationship between the cost of development and the price of drugs or devices."

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.


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