Former FDA Chief Critiques Faster Drug Approvals and Reduced Regulations

Clinical trials are needed to reveal safety risks

Dr. Robert Califf, who recently resigned from his post as commissioner of the FDA, has concerns about plans to speed up drug approvals and to dramatically reduce regulations at the agency, as advocated by President Donald Trump. He recently shared his thoughts with Kaiser Health News.

“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 drug maker 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.”

Califf also has 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 is 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.”

About 92% of drugs that enter human clinical trials don’t make it to market because they fail to show any benefit or, worse, they have unexpected toxicity, Califf noted. “Declaring a drug is safe after very little information is treacherous,” he said.

Better drugs can’t be approved if the FDA is understaffed, Califf added. He called a potential FDA hiring freeze “unfortunate” and said new staff is needed to meet the faster approval timelines and to give advice to those developing drugs so “bad mistakes” aren’t made.

The FDA has been steadily hiring staff to keep up with the growing industry it oversees. But hundreds of openings still need to be filled.

Califf said the drug industry’s most valued interaction with the FDA is “during the process of [drug] development,” which begins before a drug application is submitted for approval. FDA staff can provide timely feedback and advice that can help a company choose the right studies needed for approval, thereby speeding drug development.

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

Source: Kaiser Health News; February 14, 2017.