In the ongoing saga over Food and Drug Administration (FDA) regulation of lab-developed tests (LDTs), a group of physicians working in academic medical centers is urging the Office of Management and Budget (OMB) not to issue any guidance or rule that puts LDTs under FDA authority. The July 16 letter, signed by almost two dozen doctors led by Edward Ashwood, M.D., president and CEO of ARUP Laboratories, states that LDTs are medical testing services, not medical devices subject to FDA regulation. “Not only are these testing services not sold into interstate commerce, but these essential laboratory services are the practice of medicine, not the manufacturing of medical devices, and accordingly, our laboratories are not medical devices manufacturers,” said the letter. “We physicians practice laboratory medicine, providing medical services to patients at the request of their primary care providers, similar to the practice of an orthopedic surgeon, or other specialists. The FDA is not authorized to regulate the practice of medicine; that oversight is left to [the Centers for Medicare and Medicaid Services] and state medical licensing boards.” LDTs and the laboratories that perform them are already highly regulated under the Clinical Laboratory Improvement Amendments, state laws, and accreditation by deemed […]
In the ongoing saga over Food and Drug Administration (FDA) regulation of lab-developed tests (LDTs), a group of physicians working in academic medical centers is urging the Office of Management and Budget (OMB) not to issue any guidance or rule that puts LDTs under FDA authority.
The July 16 letter, signed by almost two dozen doctors led by Edward Ashwood, M.D., president and CEO of ARUP Laboratories, states that LDTs are medical testing services, not medical devices subject to FDA regulation.
“Not only are these testing services not sold into interstate commerce, but these essential laboratory services are the practice of medicine, not the manufacturing of medical devices, and accordingly, our laboratories are not medical devices manufacturers,” said the letter. “We physicians practice laboratory medicine, providing medical services to patients at the request of their primary care providers, similar to the practice of an orthopedic surgeon, or other specialists. The FDA is
not authorized to regulate the practice of medicine; that oversight is left to [the Centers for Medicare and Medicaid Services] and state medical licensing boards.”
LDTs and the laboratories that perform them are already highly regulated under the Clinical Laboratory Improvement Amendments, state laws, and accreditation by deemed authorities such as the College of American Pathologists, argued the physicians.
“As part of this oversight, clinical laboratory physicians and scientists, including most of the signatories to this letter, perform careful inspections of lab facilities, exhaustive review of test protocols and validation, and continually monitor laboratory performance,” they wrote. “This regulatory framework requires both extensive validation and continuous monitoring to ensure the performance, quality and reliability of diagnostic services, yet allows laboratories the flexibility to develop and validate lab tests quickly and, thus, more quickly adopt new scientific knowledge and rapidly respond to unmet public health needs.”
If the FDA were to require clearance or approval for LDTs, labs might be unable to continue offering them, the physicians say. Some testing currently performed at laboratories as LDTs will never generate the financial returns to justify the costs of obtaining FDA clearance or approval, and patients served by these tests would be left with no testing options. In some cases, there is no FDA-approved device available for testing of rare conditions, such as DNA tests for organisms that cause malaria and babesia, inherited mitochondrial diseases, and severe combined immunodeficiency. The total volume for such a test may not even reach 100 tests per year.
Contrasting Views
The point made by the July 16 letter contrasts with a recent letter from a group of five Democratic senators who urged the OMB to release a draft guidance on FDA regulation of LDTs. The July 2 letter said the draft guidance has been sitting at the OMB “for years” (NIR, July 10, 2014, p. 8). The letter was signed by Sens. Edward Markey (Mass.), Richard Blumenthal (Conn.), Elizabeth Warren (Mass.), Sherrod Brown (Ohio), and Richard Durbin (Ill.).
The potential for regulation of LDTs by the FDA has pitted groups representing in vitro diagnostic (IVD) companies against clinical laboratories. A citizen petition filed in 2013 by the American Clinical Laboratory Association (ACLA) questioned the FDA’s authority to regulate LDTs as medical devices. ACLA issued a statement July 17 praising the letter from the doctors who oppose FDA regulation of the tests.
On the other side of the debate, in early July a trade group representing makers of FDA-regulated medical devices and tests praised the senators for their letter seeking release of the guidance on LDTs. And in May, the Combination Products Coalition urged the FDA to create a single regulatory system for both IVDs and LDTs (NIR, June 5, 2014, p. 1).
Takeaway: The ongoing debate over FDA regulation of LDTs will only be resolved when the OMB makes a final decision on whether to move forward with an FDA draft guidance on oversight of the tests.
