Former FDA commissioner shares 4 thoughts on streamlining drug approvals

Robert Califf, MD, former commissioner of the Food and Drug Administration, recently shared his thoughts on drug development and improving the approval process with Kaiser Health News.

Here are four takeaways.

1. On President Trump's call for faster drug approvals.

He noted it can take years for drugmakers to develop a new drug and argued the development process — rather than the regulatory process — is what needs a boost.

"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. That's not what happens," Dr. Califf said. "The real action [occurs] 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."

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

2. On the 21st Century Cures Act.

Dr. Califf called the 21st Century Cures Act a "very well-rounded piece of legislation that will speed up product development."

The act encourages the FDA to consider several pieces of information — not just traditional clinical trial data — during the approval process. This information includes real world evidence and biomarkers, such as measuring tumor shrinkage to assess cancer survival.

"Using real world evidence in clinical trials is one that I'm particularly excited about as a way to get better answers at a lower cost and faster at the same time," Dr. Califf said.

3. On maintaining patient safety.

Dr. Califf expressed the importance of a thorough clinical trial process and said judging the safety of drugs on limited information is "treacherous."

"The concept of safety is much more complex than most people think about until they look into it deeply," he said. "All drugs have risk. None of them are absolutely safe. And the actual safety risks are only revealed through clinical trials with the same quality and number of patients involved as it takes to look at efficacy."

4. On the federal hiring freeze.

Dr. Califf said the agency requires new staff to meet the faster approval timelines and help advise companies developing drugs so they don't make "bad mistakes."

"A hiring freeze at this time when we are just revving up with 21st Century Cures is unfortunate," said Dr. Califf. "I hope that the dust will settle soon and the FDA can get back to its hiring."

 

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