NEW YORK – The College of American Pathologists (CAP) on Monday called for the US Department of Health and Human Services (HHS) to end the US Food and Drug Administration's (FDA's) oversight of laboratory-developed tests (LDTs).
CAP suggested that continued FDA regulation of LDTs conflicts with President Donald Trump's Jan. 31 executive order Unleashing Prosperity Through Deregulation, which instructed federal agencies to reduce the number of government regulations as well as the cost of complying with those regulations.
“Now is the time for the FDA to pull back a regulation that adversely impacts laboratories and their ability to develop and provide these innovative tests for our patients," CAP President Donald Karcher said in a statement. "We urge the administration to act before the first stage of the rulemaking takes effect on May 6."
CAP previously asked HHS to rescind the FDA rule in a Feb. 14 letter to department secretary Robert F Kennedy Jr. and in a letter to Trump's transition team.
Some in the lab industry have seen Trump as likely to roll back the FDA rule. His election in 2016 effectively ended the FDA's efforts to regulate LDTs by guidance. In 2020, in the midst of the COVID-19 pandemic, his administration determined that the FDA would not require premarket review of LDTs without notice-and-comment rulemaking. The current final rule was produced through notice-and-comment rulemaking, however.
The administration has not taken action on the LDT rule yet, however, and has continued to defend it in the ongoing lawsuit opposing the rule filed by the American Clinical Laboratory Association (ACLA) and the Association for Molecular Pathology (AMP). That case is currently pending in the US District Court for the Eastern District of Texas. The two parties made oral arguments last week.
CAP has advocated for a legislative approach to LDT oversight, calling on Congress to pass legislation revamping diagnostics regulation, including of LDTs.
Also last week, Reps. Dan Crenshaw, R-Texas, and Brad Finstad, R-Minn., introduced a bill, the Freedom for Laboratory Innovation and Testing Act, that would prevent federal funds from being used to implement the FDA rule.