Several organizations representing physician and patient interests filed amicus briefs in support of the U.S. Food and Drug Administration defense of its final rule on laboratory-developed test (LDT) regulation.
The Center for Science in the Public Interest, an independent consumer advocacy organization, filed an amicus brief in the Eastern District of Texas in support of the FDA cross-motion for summary judgment against the motions of the plaintiffs — the American Clinical Laboratory Association and the Association for Molecular Pathology — for summary judgment. The plaintiffs are challenging the regulation of LDTs “as exceeding FDA’s statutory authority and as arbitrary and capricious in violation of the Administrative Procedure Act.”
Briefs were also filed by practicing physicians and experts in pharmaceutical and medical device regulatory policy, on behalf of Democracy Forward, and concurrently by the following nonprofit public health advocacy organizations: Public Citizen, American Cancer Society Cancer Action Network, Association for Clinical Oncology, Friends of Cancer Research, National Brain Tumor Society, and Ovarian Cancer Research Alliance.
The briefs urge the court to deny the plaintiffs’ motions to vacate the LDT final rule. They contextualize the issue of the FDA responsibility to regulate LDTs and offer support for the provisions of the final rule, arguing that the FDA has long regulated in vitro diagnostic tests, of which LDTs are a subset. Additionally, the briefs expound on the notion that the Food, Drug, and Cosmetics Act and the Clinical Laboratory Improvement Amendments of 1988 are not mutually exclusive but complementary pieces of legislation when it comes to the regulation of these tests and the associated laboratories.
Sources:
https://documents.cap.org/documents/public-citizen-et-al-amicus.pdf
https://documents.cap.org/documents/democracy-forward-amicus.pdf
https://documents.cap.org/documents/fda-brief-20241026.pdf
