Regulators ponder declaration about in vitro diagnostic products.
Dec. 4 was the end of the public comment period on a rule change that the U.S. Food and Drug Administration (FDA) proposed for medical testing across the nation. FDA analysts will begin sifting through at least 19,100 comments received about the proposal.
FDA is proposing to amend its regulations to state explicitly that in vitro diagnostic products (IVDs) are devices governed by the federal Food, Drug, and Cosmetic Act (FD&C). The new rule would cover IVDs when the manufacturer of the product is a laboratory.
FDA also would phase out its general enforcement discretion approach for laboratory developed tests (LDTs), so tests manufactured by a laboratory generally would fall under the same enforcement approach as other LDTs, according to the administration.
The Medical Device Amendments of 1976 revised the FD&C Act “to create a comprehensive system for the regulation of devices intended for human use,” including LDTs, according to FDA’s announcement in the Federal Register.
In 2023, LDTs have more risks associated with them. They are “used more widely, by a more diverse population, with an increasing reliance on high-tech instrumentation and software, and more frequently for the purpose of guiding critical healthcare decisions,” according to FDA.
FDA acknowledges the changes could lead to benefits for patients – more averted health losses for diseases and conditions – and fewer lawsuits and costs to health systems.
“Increased oversight would help to ensure the safety and effectiveness of IVDs offered as LDTs,” FDA’s proposed rule said. “More accurate diagnoses would lead to better care, which would advance public health overall. Through increased oversight, the public, including patients and health care professionals, could have more confidence that the test results they rely on are accurate.
The FDA summary notes the tests involve complex areas of medicine involving life-threatening diseases including cancer and neurological, cardiovascular, infectious and rare diseases.
But the tests are not always accurate.
False positives that indicate a patient has a disease can delay diagnosis and treatment of actual diseases or conditions, or lead to interventions with medications with serious side effects, or to risky medical procedures. False negatives may delay treatment for actual diseases or conditions. The FDA notice included examples and citations of studies that showed inaccuracies in testing.
“These studies do not mean that every laboratory is manufacturing bad tests or that no patient can rely on IVDs offered as LDTs,” the FDA notice said. “Instead, they reflect a level of variability, including the potential for inaccurate or incomplete results, that highlights the need for changes to the basic oversight scheme.”
There would be more costs for FDA and for affected laboratories complying with the rules. Estimates vary, but FDA acknowledges the financial effects will reach to the hundreds of millions of dollars, perhaps billions.
The Federal Register propose rule online includes some comments from the public about the changes. Commentators generally agreed on the FDA’s duties to ensure safe medical tests for patients, but there were warnings the new regulations will have serious effects on American health care.
The Medical Group Management Association (MGMA) said the revised rules could limit patient access to critical clinical testing, according to MGMA.
“Specifically, the new premarket review requirements may delay or deter modifications to existing tests and the introduction of new ones, hindering laboratories' ability to keep pace with scientific advances and clinical practice guidelines,” said the letter submitted by MGMA Senior Vice President for Government Affairs Anders Gilbert. “The increased administrative and financial burdens of the proposed framework would exacerbate existing cuts in laboratory reimbursement. These compounding impacts could force many laboratories to narrow or cease offering tests, further restricting patient access.”
Annette S. Kim, MD, PhD, director of the Division of Molecular and Genomic Pathology at the University of Michigan, issued a warning about the rule changes.
“The new FDA proposed rule will significantly stifle innovation and impede access to laboratory testing for patients with hematologic diseases,” Kim wrote. “Worse yet, it will reduce the quality of patient care and reduce both the quantity and competency of future qualified pathologists and other laboratory professionals who are the future of the accurate diagnoses required to treat patients with hematologic diseases.”
The FDA’s proposed rule “is truly an imminent threat to patient care and the survival of American academic clinical laboratories as they (currently) exist,” said a letter from Geoffrey Wool, MD, PhD, an associate professor of pathology at the University of Chicago.
There are “concerning examples of faulty LDTs that should be addressed,” but FDA at least must delay a decision to collect more information about the tests, and make it public, said the letter from Vanderbilt University Medical Center Professors Ritu Banerjee, MD, PhD, and Kelly E. Dooley, MD, PhD.
Consumer Healthcare Products Association asked FDA to confirm the rule change would not apply to laboratory test that are general wellness products or considered low-risk wellness products, said the letter from Marcia D. Howard, PdD, CAE, vice president for regulatory and scientific affairs. The association represents makers of over-the-counter medical products.
Due to the complexity of the topic, the College of American Pathologists asked for more time to respond, as did the American Association of Bioanalysts and the National Independent Laboratory Association.