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On the heels of a newly proposed rule from the Food and Drug Administration (FDA) to ensure the safety and effectiveness of laboratory-developed tests, U.S. Rep. Larry Bucshon (R-IN) is advocating for passage of his bipartisan legislation that would reform diagnostic testing and restrict the interstate commerce of any in vitro clinical test.

The Verifying Accurate, Leading-edge IVCT Development (VALID) Act of 2023, H.R. 2369, which Rep. Bucshon sponsored on March 29 with lead original cosponsor U.S. Rep. Diana DeGette (D-CO), would update the review process for diagnostic testing and clarify the regulatory authority between the FDA and the Centers for Medicare and Medicaid Services (CMS), according to a bill summary provided by the lawmakers.

H.R. 2369 also would limit duplication between the FDA and CMS by ensuring uniform standards are in place that support innovation, the summary says.

Since its introduction, the bill has stalled in both the U.S. House Energy and Commerce Committee and the U.S. House Ways and Means Committee.

The FDA on Sept. 29 proposed a rule regarding laboratory-developed tests, or LDTs, which are in vitro diagnostic products (IVDs), which are intended for use in the collection, preparation, and examination of specimens taken from the human body, such as blood, saliva, or tissue. 

IVDs, including LDTs, can be used to measure or detect substances, analytes, or markers in the body, such as proteins, glucose, cholesterol, or DNA, to provide information about a patient’s health, including to diagnose, monitor, or determine treatment for diseases and conditions, according to the FDA. 

The proposed rule seeks to amend the FDA’s regulations to make explicit that IVDs are devices under the Federal Food, Drug, and Cosmetic Act, including when the manufacturer of the IVD is a laboratory. Along with this amendment, the FDA is proposing a policy under which the agency intends to provide greater oversight of LDTs through a phaseout of its general enforcement discretion approach to LDTs. 

“The FDA’s proposed rule to provide greater oversight of laboratory-developed tests recognizes the need for action in this space,” said Rep. Bucshon and Rep. DeGette in an Oct. 4 joint statement. “Ultimately, to ensure the analytical and clinical validity of tests and promote patient safety, Congress must pass the VALID Act.”

The bipartisan bill, they said, would provide a long overdue modernization of the regulatory framework of diagnostics, solidifying in law the FDA’s authority to review tests. 

“We hope the conversation generated by the proposed rule will further educate our colleagues and the public on this important issue and highlight the need for Congress to pass the VALID Act,” said Rep. Bucshon and his colleague.