Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in the Bloomberg BNA Medical Devices Law & Industry Report, in “Some Genetic Tests Will Get Quicker FDA Path to Market,” by Bronwyn Mixter. (Read the full version – subscription required.)
Following is an excerpt:
Makers of genetic health-risk tests are getting a more flexible, quicker way to get their products on the market.
The Food and Drug Administration Nov. 6 said it is proposing to exempt genetic health risk (GHR) tests from premarket review under certain conditions. Under this proposal, the FDA would conduct a one-time review of manufacturers’ tests to ensure they meet agency requirements, after which they could send new GHR tests to market without further review, FDA Commissioner Scott Gottlieb said in a statement announcing the policy. …
Bradley Merrill Thompson, a Washington, D.C.-based health-care attorney with Epstein Becker & Green PC, told Bloomberg Law in an email, “Such tests do present special challenges but also significant opportunities. If used appropriately, such tests if widely accessible may cause people to live healthier lives, choosing better diets and getting more exercise if they realize they are at risk.”
“The FDA notes some of the risks that are present if the tests provide inaccurate information. They particularly focus on false negatives, but false positives also carry problems by increasing anxiety,” Thompson, who also is a Bloomberg Law advisory board member, said. “We will really have to wait and see what the real-world experience is with this new program, but frankly I’m tickled that FDA is trying to think so creatively. We really do need fresh thinking, and the agency is clearly willing to consider ideas well outside the traditional box.”
