KHN: Former FDA chief shares insights into drug approval process, Trump administration & more

Kaiser Health News interviewed Robert Califf, MD, former FDA commissioner, concerning his thoughts on the drug approval process and the current presidential administration's outlook on quickening the pace.

Here are five thoughts:

1. Dr. Califf explains there is a great deal of confusion about the drug approval process. While the Trump administration says it will quicken the approval process, Dr. Califf said the delay often stems from before the pharmaceutical company even submits an application to the FDA.

Dr. Califf said, "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."

2. He noted evidence does not indicate a direct relationship exists between the development's cost and drugs' prices, despite legislators often saying a quicker process could reduce drug development's costs.

3. Dr. Califf applauded the 21st Century Cures Act, which former President Barack Obama signed in late 2016. Dr. Califf referred the bill as a "very well-rounded piece of legislation that will speed up product development."

4. He supports in-depth clinical trials as Dr. Califf notes safety is a convoluted issue that the industry should not overlook. He said approximately 92 percent of drugs that researchers test in human clinical trials fail to obtain market approval as they prove ineffective or have unforeseen toxicity. Dr. Califf told KHN, "Declaring a drug is safe after very little information is treacherous."

5. With news swirling about a possible FDA hiring freeze, Dr. Califf said sufficient staff members are necessary to providing recommendations to pharmaceutical companies to avoid "bad mistakes." Staff can help a company participate in the appropriate studies necessary for drug approval.

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