The AAMC sent an April 2 letter to Senate Health, Education, Labor, and Pensions (HELP) Committee Ranking Member Bill Cassidy, MD, (R-La.) in response to a request for information (RFI) regarding proposals to reform diagnostic regulation, specifically regulation of laboratory developed tests (LDTs).
Highlighting the U.S. Food and Drug Administration’s (FDA) fall 2023 proposed rule on LDT oversight [refer to Washington Highlights Dec. 8, 2023], the letter described the AAMC’s long-standing position that it is essential LDTs used by clinicians to make treatment decisions are accurate and clinically valid. The letter explained, “We agree with the FDA that when LDTs are developed and marketed directly to patients outside both FDA oversight and the highly regulated, exacting environment of an [academic medical center] AMC, there is the possibility for a public health risk of inaccurate or misleading tests that should be evaluated and addressed. However, we share the concerns of our member AMCs, teaching health systems and hospitals, and clinical laboratories that the FDA’s proposed regulatory scheme would have an immediate and detrimental effect on specialized and patient-centric medical care.”
The letter detailed the unique role of academic medical centers in LDT development and their use in direct patient care. It also commented on competing regulatory proposals utilizing either the FDA or the Centers for Medicare & Medicaid Services, key considerations that must be addressed in any regulatory structure, the need for an academic medical center exemption, and the importance of any potential path forward not burdening academic clinical labs and limiting access to care for patients.
Cassidy’s RFI was released shortly before the House Energy and Commerce Health Subcommittee held a hearing specifically examining the FDA’s proposed regulation of LDTs as well as the Verifying Accurate Leading-edge IVCT Development Act (VALID, H.R. 2389), which would mandate the FDA regulate in vitro clinical tests and define detailed provisions for premarket approval, exemption criteria, and regulatory oversight of these tests [refer to Washington Highlights, March 22].