A bipartisan group of lawmakers has urged the Department of Health and Human Services (HHS) to overhaul federal drug testing regulations , arguing that "structural misalignment" at the FDA is preventing employers from using modern methods to combat a massive surge in test cheating.
The Department of Transportation in May 2023 filed a Final Rule that will allow oral fluid as an authorized testing method for the presence of unlawful drugs. Yet three years later, no U.S. laboratory has achieved certification—the blame for which the letter pins on FDA requirements. Congress in 2015 first directed HHS to recognize hair testing as a valid alternative to urine testing for commercial motor vehicle drivers, yet HHS has still not issued the necessary guidance despite Congress reaffirming that directive earlier this year.
"For far too long, HHS has dragged its feet on implementing science-based drug testing policy, and these bureaucratic delays have come at the expense of safety,” said American Trucking Associations President & CEO Chris Spear.
In a letter sent Thursday to HHS Secretary Robert F. Kennedy, Jr., six members of Congress called for the immediate removal of regulatory barriers that have effectively blocked the use of oral fluid and hair testing of safety-sensitive workers.
Led by Rep. Andy Harris, R-Md. , the lawmakers contend that current rules incorrectly treat workplace safety programs as clinical diagnostic tools—a distinction that subjects new testing technologies to the FDA’s 510(k) medical device clearance process, a pathway the letter describes as a "regulatory barrier" ill-suited for forensic occupational standards.
"These are not clinical diagnostic programs, yet current regulations treat them as such, creating delays that now threaten the relevance and effectiveness of the entire program," the lawmakers wrote.
The push for modernization comes amid a rise in urine testing subversion. Citing data from Quest Diagnostics, the letter noted that substituted and invalid drug specimens among federally regulated employees jumped 370% and 36%, respectively, between 2022 and 2023.
With zero U.S. laboratories certified for oral fluid analysis, some U.S. employers may soon be forced to send specimens to Canada—the only country with a laboratory currently seeking federal certification.
The congressional group requested that HHS take four specific actions:
- Affirm that laboratory-based workplace drug testing is non-clinical and falls outside FDA medical device authority.
- Recognize the Substance Abuse and Mental Health Services Administration (SAMHSA) as the sole governing oversight body for these programs.
- Designate SAMHSA’s Division of Workplace Programs as the authority for updating drug panels and testing technologies.
- Finalize hair testing guidelines originally mandated by Congress in 2015.
The letter emphasizes that shifting oversight to SAMHSA would not reduce safety, noting that the agency already conducts rigorous laboratory inspections and method validations that meet or exceed FDA standards for this use case.
Beyond Harris, the letter was signed by Reps. Pete Sessions, R-Texas; Mike Collins, R-Ga.; Ben Cline, R-Va.; Mike Bost, R-Ill.; and Claudia Tenney, R-N.Y.
The lawmakers have requested a formal response and an estimated timeline from HHS within 30 days.
