Dive Brief:
- The College of American Pathologists (CAP) urged the Department of Health and Human Services (HHS) to revoke the laboratory developed test (LDT) oversight regulation.
- Building on earlier efforts to overturn the regulation, the CAP published a statement Monday saying it asked the HHS to act before the first stage of the rule takes effect on May 6.
- The CAP wants the HHS to terminate the regulation in light of an executive order from President Donald Trump that calls for federal agencies to “alleviate unnecessary regulatory burdens.”
Dive Insight:
The Food and Drug Administration released a final rule on LDTs in April. Despite industry opposition, the agency has changed the regulations to classify diagnostics made by laboratories as medical devices. The change means LDTs will be subject to the same premarket reviews as in vitro diagnostics. Critics of the action claim the changes will restrict access to innovative diagnostics.
Starting May 6, the FDA will expect compliance with requirements related to medical device reporting, correction and removal and quality system complaint files. The agency will impose more requirements on LDTs every year through 2028.
The CAP, which provides laboratory accreditation programs, wants to stop the rollout of the regulation before it starts. Laboratories object to the “arbitrariness and significant costs” of the regulation, CAP President Donald Karcher said in a statement. The CAP said terminating the regulation would follow the “direction and intent of executive orders signed by President Donald J. Trump.”
Trump signed the Unleashing Prosperity Through Deregulation executive order a month ago to tackle “the ever-expanding morass of complicated federal regulation.” The order directs agencies to repeal 10 existing regulations for every new proposal and requires the total incremental cost of new regulations, including repealed regulations, finalized this year to be “significantly less than zero.”
The focus on the executive order is the latest twist on the CAP’s long-running attack on the regulation. The organization came out in support of a lawsuit against the regulation in October and wrote to Trump about the matter two weeks after he won the U.S. election in November. The CAP sent a letter about LDT regulation to Robert F. Kennedy Jr. the day after he was sworn in as HHS secretary earlier this month.
In parallel, the CAP is supporting lawmakers who have introduced legislation to prevent the FDA from using federal funding to implement the LDT regulation. Reps. Brad Finstad, R-Minn., and Dan Crenshaw, R-Texas, wrote to Kennedy last week to call for the FDA to revoke the regulation.
