Legislation that would reform how diagnostic tests are regulated will be part of the FDA’s must-pass user fee bills, Sen. Patty Murray (D-Wash.) confirmed Tuesday, a move that could settle a longstanding debate about the agency’s authority over laboratory-developed tests.
“Senator [Richard] Burr and I are working on a bipartisan policy to try and improve the regulation of laboratory-developed tests,” Murray said while presiding over the Senate Health Education Labor and Pension Committee’s pandemic preparedness hearing. Lab-developed tests are those that are designed, manufactured, and used in a single laboratory.
She said they aim to include the measure in the FDA user fee reauthorization package this spring.
Murray’s comments come less than a week after the Food and Drug Administration submitted its five-year goals for the next reauthorization of medical device user fees. The agency collect fees from brand-name drugmakers to help fund agency operations and in return agrees to meet certain performance goals. The current five-year authorization expires at the end of September.
Murray made her remarks in response to an amendment submitted by Sen. Rand Paul (R-Ky.) to limit the FDA’s ability to oversee laboratory-developed tests . Murray, the committee’s chair, succeeded in tabling Paul’s amendment in a 19-2 vote.
Murray didn’t name a specific piece of legislation, but she and Burr (R-N.C.), the committee’s ranking member, have been working for several years with Reps. Diana DeGette (D-Colo.) and Larry Bucshon (R-Ind.) on a diagnostics bill called the Verifying Accurate Leading-Edge IVCT Development, or VALID, Act (S. 2209).
“Dr. Bucshon believes now is the time for Congress to clarify the rules of the road and is diligently working to hold hearings in the House Energy and Commerce Committee on this important issue, and to get the VALID Act signed into law,” Charlotte Taylor, a spokesperson for Bucshon, said in an email.
New Product Category
The bill has undergone several iterations but at its core would create a new product category for in vitro diagnostics and then calibrate the level of FDA regulation to the risk of level of device. This would happen regardless of whether the diagnostic came from a medical device company or from a private laboratory.
The FDA has always regulated diagnostics from the device industry and historically has only exercised enforcement discretion over laboratory-developed tests because laboratories must meet the standards of the Clinical Laboratory Improvement Amendments, which are administered by the Centers for Medicare & Medicaid Services.
“Having appropriate authorities and oversight that is consistent for all tests—no matter where they’re developed—has shown to be something that is a continued challenge that needs to be resolved,” Jeff Allen, chief executive officer of Friends of Cancer Research, said in an interview Tuesday. “We certainly hope that the committees of jurisdiction do take this opportunity to work through some of the outstanding issues related to the VALID act in order to finally move this across the finish line.”
As next generation sequencing and other advances made lab-developed tests more complex, the FDA sought to exert authority over them to ensure their accuracy and usefulness.
The medical device industry embraced the proposal, but the clinical laboratory industry decried it as double regulation. The lawmakers aimed to find a legislative solution with the VALID Act that would appeal to all stakeholders.
The Covid-19 response further highlighted the importance of making diagnostics available quickly without sacrificing the public’s ability to rely on those tests results. During the early stages of the pandemic, the FDA tried to ramp up antibody testing capacity by allowing state health departments to approve the tests, but the agency ultimately tightened its oversight of antibody tests amid questions about their accuracy.