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Legal Experts: HHS Policy Change Strips FDA Of Oversight For All LDTs

August 27, 2020, Medtech Insight

Scott Danzis spoke with Medtech Insight about a Department of Health and Human Services announcement stripping the FDA of its oversight over Laboratory Developed Tests, or LDTs. Mr. Danzis says, “By the terms of the policy that was issued, it is not restricted to COVID-19 LDTs. It is broader than that. Moreover, we’ve had recent discussions with senior HHS officials who have confirmed that the intent of this policy statement is broad. It is not intended to be only applicable to COVID-19 diagnostics.”

He adds that the HHS was concerned that the FDA’s requirement that COVID-19 LDTs be put through the agency’s emergency use authorization (EUA) process was slowing test development, leading to the policy change. “That caused, I think, an HHS evaluation of how FDA has gone about overseeing LDTs, and that led to the policy statement saying that, ‘If FDA wishes to go forward with regulation of LDTs, at minimum it has to use notice-and-comment rulemaking rather than less formal means of making announcements about LDT regulation.’”

Mr. Danzis went on to say, “this policy statement from HHS, I don’t think, takes a specific position on that underlying authority, but I think what it’s saying is, if indeed there is going to be LDT regulation, FDA has to go through a more formal notice-and-comment rulemaking process. There’s a reason why the administrative procedure provides for notice-and-comment rulemaking, because it provides for public input and accountability in a way that other less-formal pronouncements do not.”

“To that extent, I think there’s some value to this policy,” he adds.

And Mr. Danzis believes that – regardless of the outcome of the upcoming U.S. presidential election, regardless of whichever administration is in place come January – the HHS statement puts pressure on lawmakers to finally develop comprehensive legislation for the diagnostics.

“There is more than one bill that has been introduced in Congress. The one that’s gotten the most attention is the VALID Act. I think this policy statement may put more attention and focus on that legislative effort,” he says.

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