Don’t Appeal ACLA Vs. FDA Decision, ASCP Urges RFK

On April 25, ASCP wrote U.S. Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr., urging the Department not to appeal U.S. District Court Judge Sean Jordon’s decision in the case of the American Clinical Laboratory Association (ACLA) et. al vs. FDA. In his decision, Judge Jordon ruled that the FDA lacked the statutory authority to regulate laboratory developed testing (LDT) services, vacating the agency’s rule (for more information, see here).  

In our letter to Secretary Kennedy, ASCP noted that “Judge Jordon wrote [in his decision] that ‘…the text, structure, and history of the [Federal Food, Drug, and Cosmetic Act] FDCA, and [Clinical Laboratory Improvement Amendments] CLIA make clear that FDA lacks the authority to regulate laboratory-developed test services.’”  ASCP also pointed out that Alex Azar, HHS Secretary during President Trump’s first term, blocked FDA from exercising oversight of LDT services because of a legal opinion from the HHS General Counsel asserting that FDA lacked authority to claim oversight of LDT services. 

ASCP, which submitted an amicus brief supporting ACLA’s case against FDA, remains strongly opposed to the FDA’s oversight of LDTs due to its excessive bureaucratic and monetary requirements, delays, and burdens. ASCP believes that maintaining the Centers for Medicare and Medicaid Services’ current oversight of these services via CLIA is critical to ensuring patient access to critical laboratory services. 

Judge Jordon’s decision gives FDA 60 days to appeal. ASCP will update its membership on whether HHS appeals the ACLA vs. FDA lawsuit.