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 MobiHealthNews, in “FDA Announces New Market Pathway for Genetic Health Risk Tests,” by Jonah Comstock.

Following is an excerpt:

FDA Commissioner Scott Gottlieb announced today that the agency intends to make a major change to its regulatory process around direct-to-consumer genetic health risk (GHR) tests. Specifically, the agency is creating a framework that will allow companies to bypass premarket certification for individual tests once they submit to a one-time review of their processes, an approach reminiscent of the FDA’s new pre-certification program for medical devices. …

Bradley Merrill Thompson, an attorney with Epstein Becker Green who specializes in the FDA’s regulation of digital health, said the approach is intriguing, especially considering that the agency is still in the early stages of the pre-cert program.

“Such tests do present special challenges, but also significant opportunities,” he wrote in an email to MobiHealthNews. “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.”

Certainly the timing is right; as MobiHealthNews noted in a feature piece last year, the market for direct-to-consumer genomics has exploded of late, even if questions remain about the technology’s usefulness and accuracy.

“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,” Thompson added. “We really do need fresh thinking, and the agency is clearly willing to consider ideas well outside the traditional box.”

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