AMA House of Delegates Unanimously Adopts ASCP Resolution on LDTs

The American Medical Association (AMA) House of Delegates on Monday, Nov. 13,  unanimously adopted an ASCP resolution calling for the AMA to urge the U.S. Food and Drug Administration (FDA) to extend the comment period on its Laboratory Developed Tests (LDTs) proposed rule. Per the ASCP resolution, the AMA will ask the FDA to lengthen the comment period by 60 days.

ASCP’s resolution was introduced because the FDA recently rebuffed requests from ASCP for a 60-day extension of the comment period on its LDT proposed rule. ASCP sought an extension of the proposed rule to ensure that stakeholders had sufficient time to review and comment on it before the December 4 deadline. Adoption of the ASCP resolution by the AMA House of Delegates means that it is now official AMA policy.

Representing ASCP to the AMA House of Delegates are: Edmund R Donoghue Jr., MD, MASCP; William Finn, MD, MASCP; Jennifer Stall, MD, FASCP; Steve Kroft, MD, MASCP; Peter DeRosa, MD, FASCP; Clifford Sullivan, MD, FASCP; and Allen Omo-Ogboi, MD. 

FDA’s proposed rule would impose an inordinately complex oversight scheme on tests developed by laboratories in support of quality patient care. Numerous professional societies representing pathologists, other physicians, laboratory professionals, and others have raised concerns about the rule; they say it could undermine the ability of laboratories to provide patients with testing services needed to ensure access to quality and timely care, particularly when no FDA-approved tests exist.

ASCP is continuing its efforts to encourage the FDA to extend the comment period on the proposed rule. The Society recently released an Action Alert, urging members to contact the FDA and Congress about extending the comment period. To request that FDA extend the comment period on its LDT proposed rule, click here. To read ASCP’s analysis of the FDA rule, click here. 

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