Califf Cautions on Faster Drug Approvals
Former FDA commissioner Robert Califf says there are five things the Trump administration should be aware of if they try to speed drug approvals and reduce FDA regulations. Interviewed by Kaiser Health News, Califf said first that faster drug approvals don’t necessarily mean less expensive drugs. “What I’m concerned about is that when people hear ‘faster approval,’ you get an image of FDA sitting on this application and, you know, twiddling thumbs,” he said. “That’s not what happens.” Califf said that the slow part of getting a drug into patients’ hands happens well before the company submits its application to FDA, since it can take decades to discover, tweak, and test a new drug molecule. It is that development process that needs a boost, Califf said.
The 21st Century Cures Act should streamline drug approvals in a positive way, according to Califf. He said the legislation encourages FDA to consider pieces of information in its approval process in addition to traditional clinical trials, including real-world evidence and biomarkers.
Califf expressed concerns about maintaining drug safety standards and ensuring thorough clinical trials. “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. Declaring a drug is safe after very little information is treacherous.”
It’s not possible for the agency to approve faster, better drugs if it is understaffed, Califf warned. He said the potential hiring freeze put in by the administration was “unfortunate” and said new staff is needed to meet the faster approval timelines and to give advice to companies developing drugs so that “bad mistakes” aren’t made. “A hiring freeze at this time when we are just revving up with 21st Century Cures is unfortunate,” Califf said. “I hope that the dust will settle soon and FDA can get back to its hiring.”
Finally, Califf said the agency is using big data to track the safety of drugs already on the market and plans to do that a lot more. He said the Sentinel system has 180 million individual electronic records and tracks every dispensed prescription, hospitalization, and serious outcome. “It’s used every day by FDA,” he said, and is getting “better and better.”