The Senate Committee on Health, Education, Labor, and Pensions (HELP) on June 14 approved a package of bills to reauthorize existing Food & Drug Administration (FDA) user fees and included new legislation (the VALID Act) which would authorize the FDA to regulate in vitro diagnostics (IVDs) including laboratory developed tests.

The HELP committee voted against including an amendment offered by Sen. Tommy Tuberville (R-AL) that would have exempted academic medical centers from the VALID Act. Committee members stated that the VALID Act already included several exemptions that all laboratories can utilize to reduce regulatory burden and that exempting some labs from regulation by the FDA established two different regulatory standards for laboratory developed tests.

One amendment accepted during the hearing would require the Government Accountability Office (GAO) to evaluate the effect of the VALID Act on hospital-based laboratories, laboratories serving academic medical centers, and other health care practitioners. The GAO would be due three years after enactment.

What is Next for the VALID Act

The FDA user fee bill, which includes the VALID Act, will now be brought up on the Senate floor for further consideration.

In the House of Representatives on June 8, representatives voted 392-28 on a separate FDA user fee legislation that did not include the VALID Act. If the Senate passes the HELP Committee’s version, the House and Senate would need to reconcile or find agreement on the two different bills before going to the president to be signed into law.

Key Facts of the VALID Act

In a letter to the HELP Committee on May 22, the CAP outlined several aspects of the VALID Act that the CAP supports. On May 27, the HELP Committee introduced the bill after reviewing comments from the CAP and other stakeholders.

Key facts include:

• Exempting all laboratory-developed tests currently in use from new regulatory oversight requirements through the VALID Act’s “grandfather” exemption.
• Laboratories may still introduce LDTs without undergoing premarket review between the VALID Act’s passage and October 1, 2027.
• The VALID Act would not be implemented for five years with an effective date of October 1, 2027, allowing ample time to further refine the regulatory framework.
• Requiring that the FDA to conduct public hearings one year from date of enactment and publish formal regulations which are subject to public comment within two years of enactment.
• Directing the FDA to avoid issuing or enforcing regulations or guidance that are duplicative of CLIA.
• Offering several exemptions from FDA pre-market review, including those LDTs that are low-risk, low volume, modified tests, manual tests, and humanitarian tests.
• Authorizing the FDA to collect user fees and establish a process by which the FDA must negotiate with the laboratory industry to set user fees, including future approval by Congress.
• Establishes mitigating measures, such as labeling, performance testing, and clinical studies, to shift higher-risk LDTs to lower tiers of regulation.

Additional information about this issue, including frequently asked questions, is available on the CAP’s website.