The American Clinical Laboratory Association (ACLA) announced today that it has retained former Solicitor General Paul D. Clement and Laurence H. Tribe, professor of constitutional law at Harvard University, for representation on matters relating to the Food and Drug Administration’s (FDA) recently issued draft guidance to regulate laboratory developed tests (LDTs) as medical devices.
Both Tribe and Clement have extensive experience in appellate matters and have represented clients in high profile cases before the U.S. Supreme Court. Tribe was appointed by President Obama and Attorney General Holder in 2010 to serve as the first Senior Counselor for Access to Justice and authored the authoritative treatise, American Constitutional Law. Clement has initiated successful administrative law challenges and constitutional litigation against the federal government, having argued more Supreme Court cases since 2000 than any lawyer in or out of government.
According to the ACLA, the FDA’s draft guidance is a regulatory overreach that could adversely affect thousands of clinical laboratories and tens of thousands of tests, and access to tests for millions of patients. Most advances in the field of personalized medicine with regard to diagnostics are the result of innovations in laboratory developed testing. Under the proposed guidance, these and future testing services developed in clinical laboratories will be subject to duplicative federal regulation and a high degree of regulatory uncertainty.
Clinical laboratories today, whether independent or associated with hospitals or academic medical centers, practice laboratory medicine, and the tests they develop for their physician clients are not commercially distributed products, the organization asserts. Rather, they are an integral part of the physician’s practice of medicine. Thus, ACLA believes that LDTs are not medical devices and that the FDA does not have the statutory authority to regulate them as devices.
“The FDA’s proposal represents a sea-change in the regulation of LDTs that will have significant negative ramifications for diagnostic innovation, and in turn, for patients, physicians, and the entire laboratory community,” says Alan Mertz, President of the ACLA. “ACLA’s decision to hire Messrs. Clement and Tribe, and their decision to take this case, should be seen as an indication of the strength of our conviction that the merits favor protecting patients, labs, and physicians from this unjustified regulatory action.” Read ACLA news releases on this topic and others.
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