Former FDA Head McClellan Weighs in on Speedier FDA

Former FDA commissioner Mark McClellan has weighed in on President Trump’s address to Congress last week where he criticized the agency’s approval process (see story) as “slow and burdensome.” In an interview with NPR reporter Audie Cornish, McClellan noted that the approval process takes only eight and a half months on average. “And most drugs that finally make it to an FDA application do get approved, which is a sign of predictability in the regulatory process and also that it takes a lot less time than it used to,” he said.

Making the review process faster would be difficult, and real gains should be sought on the drug development side before an application is submitted for review, according to McClellan. “(T)hat eight and a half months comes on the end of often years of development with lots of failed drugs along the way,” he said. “And that’s not the FDA’s fault. It’s the fault of the challenges in developing and bringing to market safe and effective medical treatments. So the big challenge today is how do we make that process more predictable and less costly and work better for patients.”

McClellan believes the development process could be helped with new sophisticated staff at FDA who are trained on some of the new statistical methods that can inform whether or not a drug is really effective and safe in actual use. “It means finding markers for whether or not a drug works and is safe that don’t require waiting a really long time,” he said. “That was transformative, for example, in getting drugs for AIDS approved much faster by not waiting to see if patients actually died of complications of the infection, but showing that a marker for effectiveness of a drug was whether or not the drug got the virus out of the bloodstream. It’s a much faster process for development and could really help bring down costs and development time.”