Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Law360, in “FDA’s Special Treatment of Big Tech Faces Mounting Scrutiny,” by Kevin Stawicki. (Read the full version – subscription required.)
Following is an excerpt:
The U.S. Food and Drug Administration is taking heat from prominent lawmakers over a special approval pathway for health software products sold by Apple, Samsung and other major tech companies, opening the door to a congressional showdown over whether the agency has the right to start such a program. …
Bradley Merrill Thompson of Epstein Becker Green, who closely tracks FDA oversight of digital health products, told Law360 that he is skeptical about the agency’s willingness to secure new authority from Congress.
“The reason they presumably don’t want to get approval is because that’s not easy to do, even for a federal agency,” Thompson said. “When you have a Congress as dysfunctional as this one, passing commonsense legislation is not an easy thing, let alone passing legislation that isn’t common sense.” …
It’s possible that the FDA will eventually expand its precertification approach, at which point questions about the legality of its actions may well hit a boiling point.
“It’s a whole different kettle of fish if you want to kick the training wheels off and not follow the congressional de novo process and only follow the precertification process, which presumably at some point the agency will want to do,” Thompson said.
Getting answers about whether Pre-Cert is legal, or whether the clock is ticking on its legality, has kept Thompson going back and forth with the FDA for years. He said the agency has repeatedly insisted it’s not sure if it needs new legal authority for the program because it’s not sure the process is novel.
“They’re absolutely doing something novel,” Thompson said, adding that convincing Congress to expand the agency’s authority won’t be easy. …
Until then, Thompson said he’ll continue to press the agency on its digital health push until the agency finds itself on Capitol Hill.
“They’re trying to do the intellectual work to create the new process, but they won’t be able to actually use it without Congress saying they can,” he said. “What bugs me is that from time to time they’ve denied that and said, ‘Sure we can,’ to which I responded, ‘Like hell you can.’”