Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled “FDA Proposes Expedited Access Program for High-Risk Medical Devices.”
Following is an excerpt:
The Food and Drug Administration is seeking public comment on a proposal to create a new program to provide earlier access to certain high-risk medical devices. ?…
“I see these programs rolled out by FDA every few years; indeed, this program is just the formalization of something that the agency started in 2011,” says Bradley Merrill Thompson, an attorney at Washington, D.C.-based law firm Epstein Becker Green. “Unfortunately, for the vast majority of companies, these initiatives really do not prove to be useful. As I recall, when the pilot program came out in 2011, there was only one company that participated. A couple years later, when they revised the program, they got only a couple more.”
Thompson has spent nearly 30 years at legal loggerheads with the FDA. He advises medical device, drug, and combination product companies on a wide range of FDA regulatory, reimbursement, and clinical trial issues. Thompson also frequently counsels companies on premarket clearance and approval strategies. The problem, he says, is that the bar for the EAP program–a product must address “a life-threatening or irreversibly-debilitating disease or condition”–is too high and the vast majority of medical device developers will not qualify.
In addition, Thompson notes that a product has to be a breakthrough technology that is above and beyond currently existing therapies. “Frankly, most medical devices represent incremental improvements,” he argues, and although most entrepreneurs proudly tout the benefits of their new products “when the FDA looks at them it characterizes the gains as more modest.”
Even if a company does qualify for the program, Thompson argues that the FDA doesn’t relax any of its standards and there is no reason to believe that the regulatory agency’s approval process will be any quicker. For the EAP program, the FDA will continue to apply the current approval standard of demonstrating a reasonable assurance of safety and efficacy.