Special Advocacy Update

• Special Alert: Court Judge Urged to Throw Out LDT Rulemaking

During a three-hour hearing at a US District Court in Plano, Texas on February 19, plaintiffs urgently asked a federal judge to rule against the Food and Drug Administration (FDA) rulemaking on laboratory-developed tests (LDTs) before laboratories must start complying with parts of the regulation in less than three months.

Attorneys for the American Clinical Laboratory Association (ACLA) and Association for Molecular Pathology (AMP) had filed a motion to hold Wednesday’s hearing due to the first stage of the LDT regulation’s implementation on May 6. Lawyers with the Department of Justice, representing the Food and Drug Administration (FDA), had agreed.

US District Court Judge Sean D. Jordan presided over the hearing and first asked both sides for how they define LDTs. Attorneys for ACLA, AMP, and FDA referred to definitions contained in documents they previously filed in the lawsuit.

Ashley C. Parrish, an attorney for ACLA, discussed the history of Congress enacting laws concerning medical devices and laboratory oversight. Through the years, Congress had multiple times to give the FDA explicit language to regulate LDTs but never did.

Judge Jordan asked an attorney representing AMP, Michael D. Shumsky, about CLIA and FDA statutes and if the FDA acted because of changes in test complexity in recent years. Mr. Shumsky responded that they do not take a position that LDTs are unregulated. He argued that tests are regulated through the Centers for Medicare & Medicaid Services and by activities like inspections and proficiency testing.

Gabriel E. Schonfeld, who represented the FDA, defended the rulemaking. He said the regulation by the FDA complements the CMS’ rules under CLIA statute. “This is not a case of the FDA exceeding its authority,” he said.

The CAP supports ACLA and AMP’s effort to nullify the LDT regulation. The CAP detailed its reasons, such as the rulemaking was arbitrary and capricious, in an amicus brief filed in October.

Organizations representing patients, physicians, and other nonprofit groups previously filed court briefs supporting the FDA.

While we await a final ruling, CAP members are encouraged to visit our laboratory-developed tests oversight page for resources and to register for the next webinar in our LDTs series.