New FDA commissioner Stephen Hahn outlined what appeared to be a business-friendly agenda for the agency in an all-hands email.
A radiation oncologist, Hahn took over as FDA chief in December after a stint as chief medical officer at Houston’s M.D. Anderson Cancer Center. In the email out yesterday, Hahn focused on three areas: better acquisition, integration and use of data; patient- and consumer-empowerment; and innovation, choice and competition.
“I strongly believe that we need to do everything we can to attain more and better data for the work we’re doing, to be more proactive in gathering data, and to be more creative and thorough in our analysis of it,” Hahn said. “By harnessing this power, we can improve our regulatory decision-making and more effectively connect today’s groundbreaking scientific discoveries with the rapid development and approval of new products.”
Patient groups and media organizations have lambasted the agency in recent years for keeping secret caches of data on medical device-related adverse events, for inconsistent and incomplete reporting of adverse events in its public database, and for failing to take action even after multiple reports of serious patient injuries and deaths. The agency has said it relies on medtech companies to submit complete reports once they’ve been notified of problems with a device.
A July 2019 article in the journal Science noted that FDA enforcement actions have plummeted during the Trump administration, most steeply from the agency’s Center for Devices and Radiological Health (CDRH). Warnings from CDRH, which regulates medtech, have dropped by two-thirds, the article said.
Hahn also promised to focus on staff recruitment and retention and reiterated a goal of previous FDA administrator Scott Gottlieb for the agency to use more real-world evidence such as electronic health records, clinical trials, medical studies and patient registries. The term “real-world evidence” includes information generated during routine clinical practice and generally means observational data obtained from sources other than randomized clinical trials, which are subject to controls.
“My hope is that consumers may be even more informed and aware about the entire lifecycle of products we regulate in order to live more healthy and productive lives,” Hahn said. “To this end, I look forward to engaging and hearing from our many stakeholders, including those representing patients, families, consumers and health professional organizations.”
Like his predecessors, Hahn also stressed balancing speedy approval of new products with the integrity of sponsor data and the approval process. Critics have taken the agency to task for allowing certain devices on the market without sufficient testing and oversight.
“This will allow us to support innovation and the development of newer, more effective products while maintaining the FDA’s gold standard for safety and effectiveness,” Hahn said. “I am proud the FDA has made tremendous strides in promoting such innovation, as I believe it provides more choices and healthy competition for America consumers and medical providers. I look to further advancing scientific and medical progress with you and to ensuring that we provide the support and information about our regulatory requirements to innovators.”