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Congressional Committee Members Publicly Release Discussion Bill on Lab Test Regulation

NEW YORK (GenomeWeb) – A plan for regulating laboratory-developed tests that a group of diagnostic manufacturers and labs had penned two years ago has resurfaced in the US House of Representatives with backing from a Republican and Democratic legislator.

Representative Larry Bucshon (R-IN) and Diana DeGette (D-CO) publicly released the discussion draft (see PDF below) of the so-called Diagnostic Accuracy and Innovation Act, which is fashioned closely after a framework developed by the so-called Diagnostic Test Working Group in 2015.

"Our discussion draft builds upon previous efforts to establish a modern framework for the regulation of diagnostic tests, which will benefit patients and advance precision medicine," Bucshon and DeGette, both on the House Energy & Commerce Committee, said in a joint statement. "This updated approach is an effort to improve public health, foster more innovation, and strike the right regulatory balance. We hope to continue a bipartisan dialogue in the 115th Congress that includes input from patient groups, clinical laboratories, manufacturers, and other stakeholders."

Back when the DTWG's plan was first circulated among industry stakeholders, legislators, and policy experts, the group included Becton Dickinson, Roche, Mayo Clinic, Laboratory Corporation of America, and ARUP Labs, but others may have joined since then. "The DAIA has benefited from collaboration with patient groups, researchers, laboratories, diagnostic test developers, innovators, and others," Bucshon and DeGette wrote in a statement today. 

As previously reported, the DTWG's plan would create a new regulatory category for in vitro clinical tests and spread oversight responsibilities for IVCTs across the US Food and Drug Administration, Centers for Medicare & Medicaid Services, and the states. IVCTs would be distinct from medical devices as defined in the Food, Drug, and Cosmetic Act, though both LDTs and test kits could be IVCTs. The FDA would oversee test development and validation, CMS would remain in charge of traditional lab activities necessary to perform testing, and states would maintain oversight of interpreting test results.

This proposal was offered by the DTWG as an alternative to the FDA's controversial draft guidance for regulating LDTs, and found its way into a House E&C draft bill. The committee has been working with stakeholders on the draft for some time.

Some in industry felt the DTWG's plan was a more favorable compromise than the FDA's proposal, which industry players have criticized as being overly burdensome, expensive, and slow. The FDA, which since the presidential elections has backed away from finalizing that draft guidance, maintains that the current oversight system where LDTs are overseen under Clinical Laboratory Improvement Amendments has significant gaps and places the public's health at risk.

However, the House E&C discussion bill, evolved from the DTWG proposal, may also not have fans among some sectors of the testing industry, mainly labs and pathologist groups that want to keep LDT oversight entirely out of the FDA's hands and make any changes to regulation by amending CLIA, which the Centers for Medicare & Medicaid Services administer. 

Groups such as the Association for Molecular Pathology and the College of American Pathologists have issued their own regulatory proposals for LDTs that would keep oversight for the vast majority of LDTs under a revamped CLIA. Meanwhile, the American Clinical Laboratory Association has maintained that labs are not devices and are beyond FDA's statutory authority, but it has worked with the House E&C on a new legislative pathway. 

The CLIA-only approach appears to have support from a number of Republican Senators, though CMS leadership has testified that the centers do not have the resources to expand oversight over LDTs. Bucshon and DeGette are inviting stakeholders to provide input on the discussion draft. 

When the FDA backed off its plans to finalize its LDT regulatory guidelines last fall, many industry observers opined that the issue, which has stirred up controversy for more than two decades, was dead for the foreseeable future. The agency, more recently, released its own discussion paper — a document without any enforcement teeth — outlining a framework for regulating LDTs, in which it tried to address industry concerns with the draft guidance.

Though the House E&C discussion legislation appears to have bipartisan support, it is unclear how far this bill will go in the current Republican-controlled Congress and with a White House that has signaled a commitment to slashing government regulation.

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