ASCP Presses Case Against FDA Oversight of LDTs

ASCP is continuing its fight against the U.S. Food and Drug Administration’s (FDA) Final Rule regulating laboratory developed tests (LDTs) and to stop legislation that would stymie the ability of clinical laboratories to provide these services to support quality patient care.

ASCP, part of a coalition of concerned pathology and laboratory societies opposed to excessive FDA oversight of LDTs, recently released an Action Alert calling on Congress to pressure FDA to suspend its Final Rule. ASCP has also written President-elect Donald Trump’s Transition Team to urge that his administration rescind the rule when he takes office on January 20. 

In addition, ASCP has been working with its coalition partners and others to urge Congress to stop FDA’s implementation of the rule.  For example, in a recent letter to congressional leaders, ASCP and others urged Congress to pressure FDA to halt the implementation of its Final Rule. The letter commented on the excessive costs of FDA’s oversight plans, noting that “according to FDA estimates, over 90% of affected laboratories are small businesses, with average annual receipts of roughly $4 million—comparable to the cost of a single premarket review submission.” With some labs having sizable LDT offerings, such costs jeopardize their ability to maintain these services.

ASCP believes FDA’s oversight scheme could ultimately force clinical laboratories, including those in academic medical centers, to stop providing patients with these essential services, even when no FDA-approved alternative exists. ASCPs’ Action Alert also took aim at the Verifying Accurate Leading-edge IVCT Development Act, or VALID Act. The VALID Act similarly empowers FDA to utilize an excessively costly and burdensome approach, and it will have a similar impact on the ability of clinical laboratories to provide LDTs. 

To ensure that patients are still able to access these essential laboratory services, ASCP urges its members, credential holders and their colleagues to use the ASCP eAdvocacy Center to send Congress the message that quality patient care demands that patients can access these testing services. Please click here.

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