ASCP Supports Legal Challenges to the FDA’s LDT Rule

The Food and Drug Administration’s (FDA) Final Rule on Laboratory Developed Tests (LDTs) continues to be the object of significant criticism from the medical laboratory community. In addition to the lawsuit filed by the American Clinical Laboratory Association in May, a new lawsuit against the FDA has emerged, this time from the Association for Molecular Pathology (AMP). The AMP lawsuit was filed on August 19.

The two lawsuits are very similar. Both challenge the FDA’s May 6, 2024, Final Rule, claiming the authority to regulate professional laboratory testing services as medical devices under the Federal Food, Drug, and Cosmetics Act (FDCA). In both cases, the parties seek summary judgment, meaning they urge the court to decide in their favor on the basis of the record and legal argument, without the need for a trial. This should help speed up a decision in the cases.

ASCP strongly supports plaintiffs ACLA and AMP in their cases challenging FDA’s legal authority to regulate LDTs. As a result, ASCP is working with several other concerned pathology and laboratory medicine organizations to jointly seek leave to submit an amicus brief supporting ACLA and AMP’s challenges to the FDA’s statutory authority.

ASCP has retained Jane Pine Wood from the law firm McDonald Hopkins to assist with its efforts. Ms. Wood has significant expertise as an attorney focused on legal issues facing the pathology and laboratory medicine community. ASCP has worked with Ms. Wood on many occasions.

In the amicus brief, ASCP as one of several amici curiae argues that the FDA’s rule is already undermining the ability of clinical laboratories to develop and use LDTs and that this is negatively impacting patient care. ASCP notes that FDA’s grant of enforcement discretion for certain tests creates significant uncertainty for laboratories and that this will create a powerful disincentive to innovate and create new tests to address patient care needs. ASCP also argues that FDA’s oversight is unnecessary and redundant as LDTs are already regulated under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, which provide the flexibility necessary for laboratories to adjust tests to the needs of individual patients. Under the FDA’s approach, such flexibility would not be possible.