ACLA Releases White Paper Detailing Legal Arguments Against FDA’s Proposal To Regulate Laboratory Developed Tests (LDTs) As “Medical Devices”

WASHINGTON D.C. – The American Clinical Laboratory Association (ACLA) today released a white paper developed by recently retained expert legal counsel, former Solicitor General Paul D. Clement, a partner with Bancroft PLLC, and Laurence H. Tribe, the Carl. M. Loeb University Professor and Professor of Constitutional Law at Harvard University. The document provides a systematic and detailed rejection of the Food and Drug Administration’s (FDA) proposal to extend its regulatory authority over laboratory developed tests (LDTs) by reclassifying LDTs as medical devices.

“In the interest of patients and their continued access to critical laboratory testing services, it is incumbent upon the FDA to reverse course and withdraw its proposed agency overreach,” said Steve Rusckowski, Chairman of the ACLA Board of Directors and CEO of Quest Diagnostics. “The ACLA white paper provides a logical and well documented statutory argument against the FDA’s attempt to regulate LDTs as medical devices, encroach upon the practice of medicine by obstructing the physician and patient relationship and bypass the required administrative rulemaking process.”

Pinpointing key flaws in the FDA’s assertion of regulatory authority over LDTs, the white paper addresses each claim with a comprehensive rebuttal backed by recognized legal and administrative precedence:

LDTs Are Not Medical Devices

“FDA’s assertion of authority over laboratory-developed testing services is clearly foreclosed by FDA’s own authorizing statute, the Food, Drug and Cosmetic Act (FDCA). On the face of the statute, laboratory-developed tests fall outside the ambit of FDA’s authority for at least three reasons: (1) they are not “devices” under 21 U.S.C. §321(h); (2) they are not “introduc[ed] into interstate commerce for commercial distribution” under 21 U.S.C. §360(k); and (3) they directly implicate the practice of medicine exempted under 21 U.S.C. §396.

Laboratory-developed testing services are performed on tissue or chemical samples at the request of an individual doctor, in the context of a specific doctor-patient relationship. Like the individual doctors themselves, the laboratories offer no physical product, but rather provide services to patients in accord with the best judgment of the treating physicians.

Thus, unlike a drug or device—which again are articles of commerce that promise all users a particular diagnosis or treatment upon application—laboratory-developed testing services function simply to inform and educate the medical practitioner, providing an extension of whatever set of tests the practitioner performs personally.

As FDA itself has recognized, such testing services are widely employed by doctors in their “clinical decision-making and disease management, particularly in the context of personalized medicine.” FDA, Oversight of Laboratory Developed Tests, 75 Fed. Reg. 34,463 (June 17, 2010).

FDA Regulation of LDTs Interferes with the Practice of Medicine

“That laboratory-developed testing services fall outside of the FDCA’s device definition is further confirmed by Congress longstanding reluctance to interfere with the practice of medicine, which is underscored by an express statutory disclaimer of such interference. Congress enacted the FDCA and its “device” definition in 1938 against a well-established background understanding that “direct control of medical practice in the states is beyond the power of the federal government.” Linder v. United States, 268 U.S. 5, 18 (1925). As the Act’s sponsor, Senator Royal Copeland, explained, “the bill is not intended as a medical practices act and will not interfere with the practice of the healing art by [persons] in the States where they are licensed by law to engage in such practice.

In 1997, Congress added a provision making explicit what had always been implicit: that the FDCA does not regulate the practice of medicine”.

FDA Use of Guidance Documents Circumvents the Requirements of the Administrative Procedure Act

“FDA’s attempt to impose burdensome requirements on laboratory-developed testing services through its ‘Guidance’ documents is unlawful for a second reason as well: the effort violates bedrock principles of administrative law. In its haste to broaden its regulatory reach, FDA has bypassed the notice-and-comment procedures that are a prerequisite to the kind of binding rules that it seeks to impose on clinical laboratories.

It improperly circumvents the carefully crafted requirements of the Administrative Procedure Act—no mere bureaucratic enactment but a cornerstone, ever since 1946, of the administrative state. Courts and Congress alike have treated broad delegations of power to executive agencies as permissible over the past six decades only because those agencies are duty-bound to comply with the APA. But FDA use of a Guidance document to effect substantive regulatory change lawlessly shields the agency from the congressional mandate that it meaningfully consider and respond to the comments it receives in the course of the public procedures Congress required.”

“LDTs are regulated under a strict and comprehensive framework that also allows laboratories to develop tests quickly and to update them regularly as research and medicine advances, giving patients access to the most current diagnostic testing available,” said Alan Mertz, President of ACLA. “Diagnostic innovation and improved patient outcomes, which have thrived under the current regulatory framework, would be threatened by the FDA device regulatory framework.”

To view the white paper in its entirety, click here.

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