The VALID Act has been refiled and the FDA has declared its intent to issue a proposed rule to enable it to oversee LDTs
Should the federal Food and Drug Administration (FDA) have the authority to regulate laboratory-developed tests (LDT)? Advocates in favor of this outcome are working to make FDA oversight of LDTs a reality.
On March 29, HR.2369—the Verifying Accurate Leading-edge IVCT Development Act of 2023 (VALID Act)—was refiled in the US House of Representatives by Representatives Larry Bucshon, MD, (R-IN) and Diana DeGette (D-CO). The 273-page proposal would move LDT oversight to the FDA.
Prior to that, however, the FDA had already announced its intention to issue a proposed rule giving the agency regulatory oversight of LDTs.
“The FDA has continually supported the passage of the VALID Act by Congress,” attorney Charles Dunham IV, a Shareholder at Greenberg Traurig LLP in Houston, told Dark Daily. “In fact, there is speculation that the VALID Act will be attached to the Pandemic and All Hazards Preparedness Act as it moves through Congress.”
Dunham is moderating a legal panel at next week’s 2023 Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management, which takes place April 28-26 in New Orleans. The VALID Act and other lab-related legal topics will be discussed by attorneys on the panel.
“The FDA may not actually proceed with promulgating rules to regulate LDTs if it is concerned it will not be successful in court if the rules are challenged, which would happen,” said attorney Charles Dunham IV (above), a Shareholder at Greenberg Traurig, LLP. Clinical laboratory leaders can learn more from Dunham during a panel discussion at next week’s 2023 Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management in New Orleans. (Photo copyright: Greenberg Traurig LLP.)
Arguments For and Against FDA LDT Regulation of LDTs
Supporters of the VALID Act contend that putting LDTs under FDA regulation will lead to improved patient safety and less review for low-risk tests. Their argument is that LDTs should undergo the same FDA review and approval process as other medical devices.
Hospital laboratory managers and pathologists—particularly in academic medical center laboratories—have largely opposed FDA regulation of LDTs. They prefer to keep the current setup under which lab-developed tests are validated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). They argue that FDA intervention will slow down development of new tests.
In fact, it was academic medical center pathologists who led the fight against the VALID Act in the last session of Congress, as Dark Daily reported in “Congress Holds Off on Enabling FDA Regulation of Clinical Laboratory-Developed Tests.” Lawmakers eventually chose not to include the VALID Act in the 2022 year-end spending bill.
In response, an FDA official indicated during the American Clinical Laboratory Association’s (ACLA) annual meeting on March 1 that the federal agency plans to issue a proposed rule to regulate LDTs, BioWorld reported. That rulemaking has not yet emerged. It’s possible the FDA will wait and see what happens in Congress with the VALID Act.
Attorney David Gee, JD, a partner at Davis Wright Tremaine LLP in Seattle, told Dark Daily that a US Supreme Court decision last year concerning the Environmental Protection Agency (EPA) casts doubt on the FDA’s ability to regulate LDTs.
“Some legal experts have suggested that one significant new legal challenge FDA may face is the Supreme Court’s West Virginia v. EPA decision last summer that limited the ability of the EPA to cap power plant emissions by regulation due to the EPA’s lack of explicit congressional authority to do so,” said Gee, who also will appear on the Executive War College legal panel next week.
“The West Virginia v. EPA ruling provides support for those in the clinical lab industry who point to the FDA’s lack of clear statutory authority to regulate LDTs and therefore fundamentally disagree with FDA’s longstanding position that LDTs are medical devices subject to FDA’s authority to regulate,” he added.
Actions Clinical Laboratory Managers Can Take
Clinical laboratory managers who want to share their thoughts about the future of LDT regulation may want to take one or both of the following actions:
- Contact their representatives in Congress.
- Find out whether any trade associations they belong to have taken a position on the VALID Act.
Clinical laboratory professionals should monitor the VALID Act’s progress while also paying attention to industry groups and manufacturers that support or oppose the bill.
Doing so will provide a clearer indication of who has the most to gain or lose should the legislation be passed. Pathologists and medical laboratory managers should also remain alert for further efforts by the FDA to issue proposed rulemaking to regulate LDTs.
H.R. 2369 Verifying Accurate Leading-edge IVCT Development Act of 2023
2023 Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management
Clinical Laboratory Improvement Amendments of 1988
Congress Holds Off on Enabling FDA Regulation of Clinical Laboratory-Developed Tests
Hillebrenner Says FDA No Longer Waiting on Congress for LDT Regulation
Looming Government Shutdown Opens Door for Congress to Possibly Pass Clinical Laboratory Bills
Theranos Whistleblower Tyler Shultz Publicly Denounces LDT ‘Loophole’ that the Disgraced Blood-testing Company Exploited