Foley & Lardner LLP partner Kyle Faget assessed the potential impact of the U.S. Food and Drug Administration’s final rule regulating lab-developed tests (LDTs) in the Wall Street Journal article, “Lab-Testing Startups Brace for FDA Rule Change,” and the potential legal challenges it may face in the Medtech Insight article, “To Be (a device) Or Not To Be. That’s The Legal Question.”
Faget, who is co-chair of Foley’s Health Care Practice Group, told the Wall Street Journal that depending on the test, complying with the regulation might not prove particularly onerous, especially if there is a similar diagnostic on the market.
Yet “it’s time and energy that wasn’t required previously,” she added.
Faget said in Medtech Insight that the FDA has held the view for decades that it could regulate LDTs based on what constitutes a device as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act.
“If you just look at the plain language of how a medical device is defined, it arguably includes LDTs. There’s nothing in there that differentiates between a medical device that is manufactured from a device manufacturer or in a single laboratory,” Faget explained. “I think it’s going to be an uphill battle to argue that FDA doesn’t have jurisdiction.”
Faget also said that prior to the final rule, the FDA was already exercising enforcement discretion of LDTs, which could be an argument against the agency’s assertion that it is within within its regulatory remit.
“Because it’s been the FDA’s pattern and practice not to enforce in this space and exercise enforcement discretion, you could query whether the FDA really thought it was within its jurisdiction,” she said, adding that she does not “think that’s a winning argument.”
On a potential challenge based on interstate commerce, Faget said, “When FDA decided to exercise enforcement discretion of LDTs, it was because they were single labs usually used on a very small local population. So, you could make an argument that these LDTs were not entering interstate commerce.”
“But it’s hard to make that argument now because so many of these LDTs are driving samples from all across the country,” she added.
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