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Senate seeks to reform diagnostic oversight via user fee bill, drawing mixed response

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Diving Brief:

  • US lawmakers are again trying to pass legislation to create a new regulatory framework for in vitro and lab-developed testing, this time by amending the FDA user fee bill that is currently in the works. consideration in Congress.
  • the revised invoice of the Senate Committee on Health, Education, Labor and Pensions (HELP) introduces an amended version of the Verifying Accurate Leading-edge IVCT Development (VALID) Act. The act divide the diagnostics industry when lawmakers previously tried to pass it in 2020.
  • HELP’s push to push VALID through the user fee bill has already proved divisive. While the American Clinical Laboratory Association, who called the VALID 2020 law “incompatible with a risk-based regulatory framework”, welcomed the draft as a “pivotal moment in the multi-year diagnostic regulatory reform effort,” the American Society for Microbiology (ASM) expressed concerns.

Overview of the dive:

The VALID Act remains an attempt to create a tiered regulatory system for in vitro clinical testing. Lawmakers want to assign all tests, whether developed by a lab or a commercial entity, to one of three risk categories.

Tests that would likely cause negative results – such as serious or irreversible harm or death – if they give an undetected inaccurate result, will fall into the high-risk category and be subject to pre-market review. The proposal exempts low-risk tests from pre-market review and offers common ground for all other tests by creating a voluntary “technology certification” program that allows companies to market products by demonstrating that they have appropriate internal validation processes. Once in the market, companies can modify their moderate-risk tests without undergoing FDA review.

The Senate HELP Committee has made the VALID Act the centerpiece of its User Fees Bill. Cowen analysts said the usage bill proposed by the House includes 40 substantive provisions, many of which relate to drugs and biologicals, but lacks a section on tests developed in the laboratory. Still, there are signs that the House is willing to consider the changes proposed by the Senate.

“The management of the Chamber seems very open to inclusion” laboratory developed tests (LDT) provisions in the final bill — provided the Senate actually passes the legislation,” the analysts wrote.

House of Law VALID sponsors — Diana DeGette (D-Colo.) and Larry Bucshon (R-Ind.) — both highlighted their continued interest in including the issue in the user fee package when markup of last week, according to analysts. . House Energy and Commerce Committee Chairman Frank Pallone (DN.J.) vowed to review anything the Senate passes on the matter, adding that it’s “rare” for the Senate to “pass anything,” said analysts in a note to investors Thursday.

While analysts see the Senate user fee bill as the “best chance for LDT oversight,” history suggests it will be difficult to enact the reforms. Lawmakers tried to reform surveillance in 2017 through the Diagnostic Accuracy and Innovation Act and tried three times to pass the VALID Act in 2018, 2020 and 2021.

Some of the previous answers elicited strong and opposing responses from different parts of the diagnostics industry. AdvaMed and the College of American Pathologists have broadly supported the 2020 and 2021 versions of the VALID Act, while groups such as The American Association of Clinical Laboratories (ACLA) and the American Association for Clinical Chemistry have raised concerns in the past.

The ACLA, which represents companies including LabCorp and Quest Diagnostics, has yet to share a detailed analysis of the latest proposal, despite being optimistic in its initial statement. He called the release of the updated VALID law “a pivotal moment in the multi-year effort to reform diagnostic regulation.”

The trade group plans to review the draft and provide feedback to the HELP committee. The ASM was more circumspect, writing in a May 15 letter to the Senate committee that it is “unreasonable” to lump clinical microbiology labs into the same category as commercial entities.