The Association for Diagnostics & Laboratory Medicine (ADLM) submitted a testimony to congress opposing the Food and Drug Administration’s (FDA) proposed laboratory developed tests (LDTs) rule.
Statement attributable to: Octavia Peck Palmer, PhD President, Association for Diagnostics & Laboratory Medicine (formerly AACC)
“Today, we at the Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC) provided testimony to Congress regarding the impact of the Food and Drug Administration’s (FDA’s) proposed rule to impose FDA oversight on laboratory developed tests in addition to Centers for Medicare & Medicaid Services (CMS) oversight. While we share FDA’s goal of ensuring that laboratory developed tests are safe and effective, we have serious concerns about the agency’s proposal. If finalized, this rule would create a burdensome dual regulatory structure that would limit patient access to many life-saving tests.
“Laboratory developed tests are already subject to stringent regulations under the Clinical Laboratory Improvement Amendments (CLIA), which are administered by CMS. Extending FDA oversight to these tests would duplicate this existing regulatory structure and would lead to additional, prohibitive costs that could force many laboratories providing laboratory developed tests to discontinue this vital patient service. The VALID Act — which would explicitly grant FDA the legal authority to oversee these tests, and which ADLM remains opposed to — would have the same consequences.
“Instead of moving forward with either FDA’s proposal or the VALID Act, ADLM believes that the FDA should withdraw its proposed rule and work with the laboratory community, patients, and Congress to update CLIA’s already rigorous standards. We firmly believe that this is the most effective way to reinforce patient safety while still fostering innovation and enabling labs to meet patient needs.”
