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- ACLA Files Lawsuit Against FDA by Challenging LDT Oversight Regulation
The American Clinical Laboratory Association (ACLA) filed a federal lawsuit challenging the Food and Drug Administration (FDA) and its final rulemaking on the oversight of laboratory-developed tests (LDTs) on May 29. The CAP is reviewing the legal action by ACLA, which included a 450-page filing in the US District Court for the Eastern District of Texas. The CAP has expressed its continued concerns to various stakeholders over the FDA regulation and the impact it will have on pathologists, laboratories, and patients.
In a statement, ACLA said they brought this lawsuit because the FDA final rule exceeded the agency’s authority and violated the Administrative Procedure Act, which establishes the federal rulemaking process for federal agencies to follow.
Following the release of the FDA final LDT rule, the CAP said it remained concerned that the FDA moved forward without making the additional changes needed to ensure both patient safety and access to accurate and innovative testing. CAP President Donald Karcher, MD, FCAP had said in a statement, "We urge the FDA to reconsider the CAP’s prior feedback in light of the real-world effect its strict regulation will have on pathologists and laboratories meeting the needs of a diverse patient population across the United States. Importantly, FDA must conduct a massive outreach and education campaign on how laboratories can meet these regulatory requirements and still care for patients as the new rules are implemented.”
The CAP will provide additional updates on this issue as new information emerges.