No matter your perception of the FDA's product approval process right now, Jeffrey Shuren argues that regulators have improved the complex system, and that the process is already getting better for medical device companies. What's more, the director of the agency's Center for Devices and Radiological Health (CDRH) says an infusion of funds from the new user fee legislation will help boost efficiency even further.
Shuren spoke about the regulatory environment at recent event in Memphis. Why there? Memphis bills itself as the second-largest, medical device-manufacturing city in the United States. (Warsaw, IN appears to be number one.) Memphis' The Commercial Appeal covered his talk at length in an enlightening story about how the FDA's chief regulator views the state of a regulatory approval process that has long been a point of anxiety for device companies.
He reminded his audience that CDRH began reviewing how his division handles regulatory approvals almost two years ago. The story quotes Shuren as pointing to new policies the agency began implementing in April to help make the approval process more predictable and efficient. Among the specific changes, as we told you in March: FDA officials issued new guidance for PMA applications for high-risk medical devices and also de novo petitions, which is an approval pathway for novel devices of low-to-moderate risk.
The changes have helped, the CDRH head told his audience, and are beginning to shorten average decision times, with regulators returning applications to companies less often for revisions. Further improvements will come, Shuren said, with the passage of device and drug user fee legislation. The bill more than doubles devicemaker approval fees over 5 years, to about $609 million, with the extra money designed, in part, to help hire more review scientists and speed up approval times.
"The good news is we're seeing the canary in the coal mine is actually singing these days," Shuren told his audience, as quoted in the article, also noting that the overall changes are designed to create a more apolitical approval process that's smoother in the long run.
We'll see. In the meanwhile, not everyone is convinced. BioNanovations' Chief Technology Officer, Andre Simmons is quoted in the story as saying that new FDA websites and "seasoned mentors" have helped take some of the anxiety out of the approval process. But the process remains tough because regulators "want to protect everybody."
"So, is it going to get easier? I don't think so," Simmons said.
- read The Commercial Appeal piece