The House Energy and Commerce Subcommittee on Health will convene a hearing on March 21 on diagnostic test regulation and the impact of the U.S. Food and Drug Administration proposed rule to regulate laboratory-developed tests (LDTs).
“The FDA has proposed a rule that relies upon dubious and misguided legal, economic, and public health arguments and has provided limited opportunities for stakeholders to offer input,” said House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-Wash.) and Health Subcommittee Chair Brett Guthrie (R-Ky.) in a joint statement. “Any paradigm-shifting changes to the current regulations must come from Congress — not the Executive Branch.”
The FDA notice of proposed rulemaking (NPRM) regarding LDTs was published on Oct. 3, 2023. If finalized, the rule would phase out the general FDA enforcement approach for LDTs so they would fall under the same enforcement as in vitro diagnostic (IVD) tests. The FDA claims this approach would ensure the safety and effectiveness of LDTs and “foster the manufacturing of innovative IVDs.”
The witness panel will include Susan Van Meter, president of the American Clinical Laboratory Association (ACLA). “We firmly maintain that LDTs are not medical devices and regulating them as such would be harmful to patients and would severely hamper innovation in the next generation of diagnostics,” Van Meter wrote in a Feb. 1 statement. “Rather than imposing a device framework that is inappropriate for LDTs, ACLA encourages FDA to work with Congress, ACLA, and other stakeholders to develop legislation that would establish a role for FDA in the regulation of LDTs aligned with their already robust oversight.”
The hearing will be open to the public and press and will be live streamed online at 10 a.m. on https://energycommerce.house.gov.
https://www.acla.com/acla-statement-on-ldt-proposed-rule-comments-by-fda-and-cms/
