On July 31, 2014, the Food and Drug Administration (“FDA”) announced that it would begin regulating laboratory developed tests (LDTs). According to the FDA, LDTs are designed, manufactured, and used within a single lab, and include some genetic tests and tests that are used by various health care professionals. These tests are developed by hospitals, academic, and clinical laboratories in response to unmet clinical needs to ensure patients receive the best possible care. The FDA considers these tests to be medical devices.
The FDA notified Congress that it plans to publish its draft guidance as to its regulation of LDTs. The notification described details of the draft guidance whereby the FDA would establish a risk-based approach to regulate LDTs. The FDA claims that it has authority to regulated LDTs based upon the Federal Food, Drug, and Cosmetic Act (“FDCA”), which gives the FDA power to regulate medical devices. Moreover, the FDA already oversees direct-to consumer tests, and has simply chosen to exercise enforcement discretion over LDTs.
While clinical laboratories are already heavily regulated by the Centers for Medicare and Medicaid (“CMS”) under the Clinical Laboratory Improvement Amendment (“CLIA”), as well as state laws and accreditation authorities, the FDA is concerned that compliance with the CLIA is not sufficient since the CLIA addresses different functions from the FDCA. The CLIA governs laboratory practices, such as accreditation, inspection, and certification, whereas the FDCA ensures that the diagnostic devices themselves are safe and effective by evaluating the design, manufacture and/or validation of the device itself. Therefore, the FDA seeks to regulate both analytical and clinical validity using a premarket clearance or approval process.
Toward that end, the FDA plans to classify LDTs into three different categories, based upon a variety of risk factors. LDTs classified as Class I constitute the lowest risk and will be subject only to general controls, whereas LDTs classified as Class III are considered the highest risk and subject to general controls and premarket approval. General controls will include such things as prohibitions on adulteration and misbranding, establishment registration and device listing, and compliance with certain remedies, to name just a few. Pre-market review will allow for increased enforcement and oversight before the LDT reaches the public. There will also be guidance regarding post-market review in terms of adverse event reporting requirements. The FDA plans to use expert advisory panels to classify LDTs, and based upon feedback received from the industry, the agency intends to phase in certain LDTs based on this risk-based classification. Certain LDTs, such as those for which there is no approved alternative, as well as those that target rare diseases, will be exempt from FDA review.
This is not the first time that the FDA has proposed regulating certain lab-developed tests. In 2006, the agency attempted a similar proposal but was fiercely opposed by many in the field, as it is now. Those who practice in clinical laboratories feel that adding a second regulator to an already heavily regulated industry is unnecessary, unwise, and overly burdensome. First, in addition to the extensive regulation by CMS, there are other mechanisms in place, like peer reviews, which insure clinical validity. Additionally, individuals in this field do not view LDTs as medical devices; instead, LDTs are testing services, which constitute the practice of medicine. The FDA is not authorized to regulate the practice of medicine, which is a task left to CMS and state medical licensing boards. Additionally, clinical laboratory professionals fear this added regulation would stifle test improvement and product innovation so that patients would not receive up-to-date and necessary tests. This is why numerous laboratory directors and pathologists from academic medical centers across the country have urged the FDA to refrain from issuing any draft, proposed, or final guidance or rule regulating LDTs as medical devices. Their letter to the Office of Management and Budget may be found here.
The FDA guidance is silent as to the preemptive effect the FDA regulations might have on state laws. In New York, there is extensive validation review of LDTs before the laboratories are allowed to use these tests. It is unclear whether or not these FDA regulations will now impair New York and other states’ rights to engage in their own validation review.
The public will have an opportunity to comment on these draft regulations, which will be released approximately 60 days from the date of the FDA’s notification to Congress. Hopefully, there will also be additional guidance as to whether or not the FDA regulations will preempt state laws. Either way, it is likely that there will be a fierce debate between those in the field who oppose the agency’s decision to begin regulating LDTs and the proponents of the decision, such as some medical societies, patient advocacy groups, and manufactures of tests that are subject to FDA, who believe added regulation is necessary to ensure that test results are accurate, consistent, and reliable.