Dive Brief:
- The Association for Diagnostics and Laboratory Medicine (ADLM) has urged lawmakers to rescind the final rule on the regulation of laboratory developed tests (LDTs).
- In a letter sent Thursday, the association shared survey data with politicians including Sen. Bernie Sanders, an independent from Vermont, to make the case that they should intervene in the Food and Drug Administration’s plans to change the oversight of LDTs.
- The survey of ADLM members found 48% of labs will stop performing LDTs if they do not qualify for an exception under the FDA final rule. More than 60% of labs said there is no other site in their state that offers the same test.
Dive Insight:
The FDA finalized a rule strengthening its authority over LDTs in April. The rule would treat LDTs as medical devices, meaning new tests must be authorized by the FDA. Tests that were already sold prior to the final rule would be subject to enforcement discretion if they haven’t been modified.
Since then, the American Clinical Laboratory Association and Association for Molecular Pathology have filed lawsuits against the FDA, and groups including the American Medical Association have warned about the impact the rule could have on access to testing.
The ADLM, a professional body formerly known as the AACC, surveyed its members and sent the results to lawmakers. The survey, the third conducted by the ADLM, asked labs about an FDA provision that allows them to skip agency review if their LDTs are approved by the New York Department of Health’s Clinical Laboratory Evaluation Program. That provision exempts labs from FDA pre-market review, but they would still have to meet requirements around labeling, registration, medical device reporting and inspection, the ADLM said.
Nearly half of the 121 respondents said they would discontinue their LDTs rather than seek FDA clearance or approval if they do not qualify for an exception. When there is no alternative to the LDTs, the ADLM said ending test offerings “will create a hardship for many individuals, particularly among marginalized communities, and those living in rural areas.”
The survey suggests many labs that try to keep LDTs on the market will need to grapple with regulatory processes for the first time. More than 80% of survey respondents have never filed a submission, leading the ADLM to say the labs “are likely to need significant help gathering and submitting the data and incur sizable costs.”
The ADLM presented the data to make the case that lawmakers should rescind the FDA final rule “while courts determine whether the agency has the legislative authority to regulate these tests.” In parallel, the group is encouraging Congress “to discuss separate remedies to streamline the FDA review process and review and update [Centers for Medicare & Medicaid Services] standards pertaining to LDTs.”
