ADLM Supports Letter Asking How the FDA Plans to Abide by SCOTUS Decision Limiting Power of Federal Agencies

WASHINGTON (July 2, 2024) — Octavia Peck Palmer, PhD, president, Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC), has released the following statement:

“On June 28, in Loper Bright Enterprises v. Raimondo, the Supreme Court overturned the so-called Chevron doctrine and reinforced that Congress and the courts are responsible for writing and interpreting laws, respectively, not federal agencies. In response to this landmark decision, Representative Bill Cassidy, MD (R-La.), sent a letter to the Food and Drug Administration (FDA) today asking how the agency plans to implement this new framework, especially considering the fact that, under this new ruling, many of the agency’s actions in recent years are now officially considered to be outside the bounds of its authority.

“One of these actions, which Rep. Cassidy uses as an example in his letter, is the FDA’s decision to publish a final rule bringing laboratory-developed tests under FDA oversight even though Congress hasn’t granted the FDA authority to do this. 

“Laboratory developed tests are already regulated by the Centers for Medicare & Medicaid Services (CMS) via the Clinical Laboratory Improvement Amendments, and we at the Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC) have long asserted that dual FDA-CMS regulation of these tests will be burdensome and costly for clinical labs. It will force many labs to stop performing these essential tests, which would have a tremendous negative impact on patient care.

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“ADLM, therefore, strongly supports Rep. Cassidy’s letter to the FDA, and we appreciate that he asks the agency in great detail how it plans to change its current practices to enforce the laws as Congress writes them, instead of improperly legislating via agency action. We look forward to the FDA’s answers to Rep. Cassidy’s questions. 

“In particular, we hope the agency will take this opportunity to halt its laboratory developed tests rule. We encourage the FDA to instead bring up this issue with the Clinical Laboratory Improvement Advisory Committee, which is the appropriate venue for discussing changes to current laboratory standards—a move that would be in concordance with the Loper Bright decision.”

- This press release was republished with permission from the Association for Diagnostics & Laboratory Medicine