Experts: Don’t Look to Congress For FDA LDT Guidance Fix

Legislation to overhaul the FDA probably won’t touch the regulation of laboratory-developed tests, experts say.

Draft legislation now being circulated by the House Energy and Commerce Committee does not address the FDA’s right to regulate the tests, but some still hope LDT provisions will be added to a final version of the bill (see related story). LDT regulation has been addressed by both houses of Congress in larger 21st Century Cures hearings.

The FDA issued a risk-based LDT regulation proposal in 2014 to act on a perception that the increasingly complex nature of the tests and their proliferation in healthcare settings warrants stricter regulation than they currently get under the Clinical Laboratory Improvements Act, which is administered by the Centers for Medicare & Medicaid Services.

Speaking at a recent webinar hosted by the American Association for Clinical Chemistry, attorney Peter Kazon, with Alson & Bird, said he believes the FDA’s draft guidance on LDTs will be finalized without congressional involvement. Absent congressional intervention, he expects the final guidance to be issued by the end of 2016 to avoid needing to restart in a new administration.

Kazon and Vanderbilt School of Medicine’s James Nichols both expressed concern that the FDA’s and CMS’ oversight mechanisms will overlap, confusing labs and test equipment manufacturers. Nichols also wants the agencies to clarify how many times labs would be inspected and by which agency.

While a recently announced FDA-CMS task force on LDT regulation may help in that regard, it won’t alleviate manufacturers’ concerns completely, Kazon says. “The joint task force may look at the overlap between [quality system regulation] requirements and CLIA, but that doesn’t solve many of the concerns that have been raised about the guidances in general,” he tells IDDM.

“Moreover, while it may clarify where the line is between QSR and CLIA, it doesn’t answer the questions that many laboratories will have concerning how to comply with the QSR requirements themselves,” Kazon says.

FDA manufacturing standards also could hurt LDT makers, the lawyer says. While laboratories already follow common international standards to ensure safety, these aren’t used when sourcing solvents, salts and other raw materials used in making diagnostics under the FDA’s quality management systems rules. The draft guidance also leaves questions about how LDTs will be classified, Kazon says.

Moreover, clinical lab resources already are strained due to low reimbursement levels, Nichols notes. Investing toward research required for FDA approval, as well as any user fees the FDA imposes, could squeeze some labs out of the business, he says. — Elizabeth Orr