A new legal whitepaper authored by two of America's most prominent lawyers argues that the US Food and Drug Administration's (FDA) plan to regulate lab developed tests (LDTs) more similarly to traditional medical devices lacks legal justification and is therefore unlawful.
For more on LDTs and why and how FDA wants to regulate them, please see our August 2014 explanation of the policy shift here.
The legal analysis is co-authored by Paul Clement, the former US Solicitor General and a frequent litigator before the Supreme Court, and Laurence Tribe, a Harvard professor and a prominent legal scholar, on behalf of the American Clinical Laboratory Association (ACLA), which the duo are representing in its fight against FDA's proposed LDT policy.
"FDA claims that Congress granted it this expansive and previously unexercised power nearly 40 years ago, through provisions that (unlike the Clinical Laboratory Improvement Act, CLIA) do not even mention laboratories or laboratory testing services and expressly disclaim any intent to regulate the practice of medicine," they write.
Are LDTs Devices, or Medical Services?
However, as they note, FDA's argument isn't necessarily predicated on CLIA, but is instead based on their argument that LDTs are, in effect, medical devices, and therefore fall under the agency's existing authority given to it under the Federal Food, Drug and Cosmetic Act (FD&C Act).
Clement and Tribe refute this argument off-hand, saying that "laboratory-developed testing services are not devices," but are instead medical services.
"[L]aboratory testing services and medical devices raise completely different regulatory issues—as Congress itself recognized in enacting a distinct regulatory framework for clinical laboratory tests in CLIA, and in charging CMS rather than FDA with CLIA’s oversight of laboratories," they explained. A medical device is a product, they note; an LDT is a service composed of proprietary methodologies that results in a report that informs clinical decision-making.
A device, they note, is defined as a "product," so by arguing that it is in fact a "service," they hope to undermine FDA's argument for its authority over LDTs.
FDA, meanwhile, has argued this distinction is meaningless, and that many modern LDTs resemble more traditional in vitro diagnostic (IVD) products. However, Clement and Tribe argue the lack of a sale—LDTs are for use exclusively within the lab which develops the product—is perhaps the key differentiator between the two similar products.
Impacts and the Administrative Procedures Act
Whatever the merits of their argument, Clement and Tribe were also eager to point out the perceived harms of FDA's LDT proposal in their whitepaper. "FDA’s effort to expand its jurisdiction will directly interfere with the practice of medicine, and will disrupt the ability of doctors to obtain the laboratory tests they need to provide the best possible care to their patients," they claim. FDA does not have the authority to regulate the practice of medicine, which also prevents it from regulating off-label prescribing of prescription medication or the minimal manipulation of cell and tissue products.
The duo also take issue with FDA's attempts to alter its approach to LDT regulation through the guidance document process, which they claim is breaking one of the "bedrock principles of administrative law" by bypassing traditional "notice-and-comment" procedures.
ACLA Paper on LDTs