FDA Commissioner Stephen Hahn
The head of the FDA says some changes the agency made during the height of the COVID-19 pandemic will become permanent.
Dr. Stephen Hahn told members of the Medical Device Innovation Consortium (MDIC) on June 19 that the agency will rely even more on real-world evidence regarding the performance of approved or cleared devices and update its decisions on devices when necessary. The FDA had to boost its reliance on real-world evidence during the pandemic as it weighed which devices and tests qualified for emergency use authorizations (EUAs).
For example, the agency on April 24 issued an EUA list of 74 respirator manufacturers. By May 7, the agency removed 60 respirators made in China from that list once reports came in indicating they may have been substandard.
The FDA announced on June 17 that it revoked the EUA for the Chembio DPP COVID-19 antibody test due to accuracy concerns. Chembio’s IgM/IgG SARS-CoV-2 serological antibody test received an EUA in March as a fingerstick-style test designed to use the company’s MicroReader 1 and MicroReader 2 analyzers to detect IgM and IgG antibodies and offer results within 15 minutes.
“Some of that product hadn’t been approved by us and we had to show flexibility because time was our enemy on this,” said Hahn, who took over as FDA commissioner in December, just a few months before the first cases of COVID-19 were identified in the U.S. “We used the data we had, and when we had more data we updated our emergency use authorization.”
Real-world evidence has “been critical during the pandemic because we’ve had to make some pretty quick decisions with the data available,” Hahn told members of the public-private group. “We will really work on that a lot in the upcoming years to incorporate that further. The question is, how do we do that in a robust way so that we have the right information for the decisions?”
That is indeed the question. The 21st Century Cures Act, passed by Congress in late 2016, promotes the use of real-world evidence. The practice offers a way for a medtech company to prove safety and efficacy without necessarily having to conduct a clinical trial. The FDA issued final guidance on the use of real-world evidence in August 2017.
In a different final guidance issued in September 2019, the agency said it would require medtech companies seeking premarket, de novo and humanitarian device approvals to submit timely postmarket study data or risk losing those approvals. In that guidance, the agency acknowledged the difficulty of postmarket data collection and asked medtech companies to use real-world data on breakthrough devices to meet agency deadlines and provide reliable and relevant data. The agency said it would work with manufacturers on data submission timeframes with the “least burdensome approach” for the companies.
The real-world evidence vs. randomized clinical trial debate has been going on for years, according to Michael Drues, president of Vascular Sciences and a San Diego-area regulatory consultant who has worked with medical device companies and FDA.
“The question is simple,” Drues said in an email to Medical Design & Outsourcing. “Do industry and the FDA want to continue to consider the randomized controlled trial the ‘gold standard,’ even though most randomized clinical trials are so carefully controlled they are not realistic of the way we use medical devices in the real world? Or should we be willing to consider using good-quality real-world evidence in the right circumstances in addition to or perhaps in lieu of a randomized controlled trial, as real-world evidence is more reflective of how devices are used in the real world? After all, what’s the point of doing a clinical trial or any test if it’s not realistic? As a regulatory consultant, biomedical engineer and potential patient, I’m more concerned with how products function in the real world rather than in the theoretical world of regulatory affairs where so many seem to assume people read and follow what’s on a devices label.”
Agency critics claim that FDA has had trouble collecting postmarket data from medtech companies because patients, health providers and the companies themselves fail to cooperate. Major investigative reporting initiatives by Netflix and the International Consortium of Investigative Journalists have also faulted the agency for its failure to act on numerous serious adverse-event reports for certain devices.
Last week, Hahn told MDIC that the FDA “will have an even closer collaboration with the incredible private sector that we have in this country.”
“Let’s keep those (pandemic-era changes) in place as we move forward beyond COVID-19,” Hahn added. “What are the things that we can change from a regulatory practice and procedure point of view to continue to accelerate medical product development outside of COVID-19 so the lessons learned about what worked and what can be improved can be applied to the future?”
