Bradley Merrill Thompson Quoted in “Elizabeth Warren, Colleagues Pen Critical Letter on FDA Pre-Cert”


Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in MobiHealthNews, in “Elizabeth Warren, Colleagues Pen Critical Letter on FDA Pre-Cert,” by Jonah Comstock.

Following is an excerpt:

The FDA’s Pre-Cert program has fallen under new scrutiny as the agency received an open letter today from three senators: Elizabeth Warren (D-Mass.), Patty Murray (D-Wash.), and Tina Smith (D-Minn.).

The 12-page letter contains no less than 50 questions for the agency about the program, ranging from how it will derive its statutory authority to how it will pay for the program absent traditional user fees. The senators have requested a reply by November 9, 2018. …

Since new FDA Commissioner Scott Gottlieb announced the FDA precertification program, the agency has been moving full speed ahead to re-invent its process for clearing digital health products. Pre-Cert will emphasize a focus on evaluating “standards of excellence” for the company or firm, rather than focusing on specific products. The idea is that trusted shops will be able to iterate technologies at their own pace.

While many support the program, critical voices have also begun to emerge. Bradley Merrill Thompson, a member of the firm at Epstein Becker Green who also helps lead the Clinical Decision Support Coalition, laid out some of his own concerns in a recent editorial for MobiHealthNews.

In a recent reader poll, 63.4 percent of MobiHealthNews readers supported the program, 7.1 percent opposed it and 28.6 felt there wasn’t enough information currently available about the program.

This is the first significant public pushback we’ve seen to the program. While some of the concerns echo those raised in Thompson’s piece, others go even further, suggesting that there’s a risk of the proverbial foxes running the henhouse when companies are put in charge of their own evaluation, and at times even seeming to suggest that the FDA might be abdicating its responsibilities to ensure the safety and efficacy of medical devices.