The House Energy and Commerce Subcommittee on Health held a hearing on Thursday, March 21, to evaluate approaches to diagnostic test regulations and the recently proposed rule from the U.S. Food and Drug Administration to regulate laboratory-developed tests (LDTs).
In September, the FDA announced the proposed rule seeking to amend the definition of in vitro diagnostic tests, including LDTs, to be “devices” under the Food, Drug, and Cosmetics Act. The rule would phase out the current general enforcement discretion approach for LDTs and would be implemented in five stages over a four-year period. The Office of Management and Budget is reviewing the proposed rule, and the final rule is expected to be published later in April 2024, absent congressional action.
“Under the proposed rule, laboratories will incur significant costs to come into compliance. New administrative and clerical burdens, along with oppressive submission fees, will be a substantial drain on a lab’s limited resources … By FDA’s estimate, 50 percent [of tests] will require premarket submissions. That alone translates to hundreds of millions of dollars, not even accounting for ongoing changes in maintenance,” Committee Chair Cathy McMorris Rodgers (R-Wash.) said in her opening statement.
The witness panel, including American Clinical Laboratory Association (ACLA) President Susan Van Meter and College of American Pathologists President Donald S. Karcher, M.D., generally decried the current regulatory framework for LDTs and expressed support for legislative action to be taken on the issue. All panelists were concerned about the impact of the proposed rule on testing innovation and patient care, while nearly all panelists voiced support for the Verifying Accurate, Leading-edge, In Vitro Clinical Test (IVCT) Development (VALID) Act (H.R.4128/S.2209).
The VALID Act outlines a specific regulatory framework for IVCTs, including LDTs. The bill requires the FDA to regulate IVCTs, setting a risk-based mechanism for regulation and establishing a technology certification pathway for IVCT developers to receive a laboratory or company-based certification for tests. Finally, the bill would require information to be publicly available on the types of available tests, test labeling, postmarket monitoring and reporting, and quality and design requirements.
“ACLA maintains that legislation is the right — and only — approach for FDA to regulate the professional testing services provided by laboratories,” Van Meter said in her witness testimony. “FDA’s proposed rule — which would subject virtually all laboratory testing services to medical device regulation — would significantly undermine the ongoing ability of laboratories to develop and offer the innovative testing services relied on by millions of patients and their physicians.”
Sources:
https://d1dth6e84htgma.cloudfront.net/03_21_2024_HE_Hearing_Public_Memo_198b5fd6c3.pdf
https://d1dth6e84htgma.cloudfront.net/Susan_Van_Meter_Witness_Testimony_03_21_2024_2f6fa42146.pdf
