Legislative Update

Federal Regulation of LDTs Subject of Proposed Bill

Two federal lawmakers release draft of a bill that would deal with laboratory-developed tests

THERE’S A NEW BATTLE over laboratory-developed tests (LDTs) looming on Capitol Hill. In response to the FDA’s draft guidance to regulate LDTs, a bill has been proposed by two members of the house that would shape LDT regulations in different ways than proposed by the FDA.

The Diagnostic Accuracy and Innovation Act (DAIA) was made public on March 21 by U.S. Reps. Larry Bucshon, MD (R-Ind.) and Diana DeGette (D- Colo.). They called it “a discussion draft” of the DAIA and asserted that this law would provide a predictable and timely path to market for innovative diagnostic tests.

Bucshon and DeGette also said that the DAIA builds on previous work, meaning that of the Diagnostic Test Working Group (DTWG). This is a group that represents large clinical laboratories and companies that develop diagnostic tests. The DTWG was created in response to the FDA’s 2014 proposal to regulate LDTs.

FDA’s New Stance

The FDA proposal stirred up a firestorm of opposition across the clinical laboratory industry. It was a proposal that seemed to have few friends within the house of laboratory medicine. For example, both of the national lab companies went on the record as opposing the FDA’s proposed LDT guidance.

In November 2016, after the federal election, the FDA said it would halt its movement in that direction while the new administration took office. Then in January, the FDA issued a discussion paper on LDTs, which it said did not represent the formal position of the agency and was not enforceable. “We hope to simply advance the public discussion by providing a possible approach to spur further dialogue,” the FDA said.

What Comes Next For LDTs?

That seems to have set the stage for the emergence of the proposed Diagnostic Accuracy and Innovation Act. But every bill that surfaces in Congress is because some individual or group has raised the need for such a bill with sympathetic lawmakers.

Thus, to understand who would benefit from the language of this bill, it is necessary to know which lab industry companies and vendors brought this issue to the attention of Bucshon and DeGette. That is the more interesting story which has yet to be told. Some lab professionals familiar with the language of the DAIA say that it appears to reduce regulation of the test kits manufactured by the IVD companies while increasing the regulatory burden for labs performing LDTs. If true, then another lab industry fight may be about to commence.

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