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Labs, Providers Strongly Oppose FDA LDT Proposed Rule in Public Comments


NEW YORK – In nearly 7,000 public comments submitted in response to the US Food and Drug Administration's proposal to oversee laboratory-developed tests, laboratories and providers across a wide spectrum of the healthcare market strongly oppose the agency's plans.

The comments also, however, indicate different medical specialties may take different views of the FDA proposal, with oncologists and oncology organizations, in particular, more favorably disposed to increased oversight of LDTs.

The FDA released its proposed rule for the oversight of laboratory-developed tests at the beginning of October 2023 and provided a 60-day public comment period through Dec. 4. As of Jan. 18, the agency had collected and posted 6,707 public comments, making them available for viewing and downloading. The FDA must review and respond to these comments when issuing its final rule, and failure to sufficiently respond to substantive comments can potentially provide a basis for legal challenges to the rule.

Of the 6,707 comments, roughly 2,900 were in favor of the rule and roughly 3,700 were against, with the remainder offering feedback on the proposed rule but neither supporting nor opposing it, based on an analysis of the comments by GenomeWeb. Of the roughly 2,900 comments favoring the rule, nearly all (2,844) came as a single form letter. GenomeWeb was not able to determine who created the form letter.

The majority of negative comments also came as form letters, with three different letters accounting for roughly 2,400 of the public comments against the rule.

Of the roughly 1,350 comments not derived from form letters, nearly all opposed the FDA rule, though with some notable exceptions. Commenters were given the opportunity to select what segment of the industry they represent. Most did not, but of those who did, 65 selected academia, 11 selected professional association, 13 selected consumer group, 167 selected the medical device industry or a medical device industry association, 26 selected the drug industry or a drug industry association, and six selected the food industry.

"Government" or "federal government" were selected by 125 commenters as their affiliation, but most of these commenters do not actually appear to be part of the government, one exception being US Sen. Rand Paul, R-Ky., who opposes the rule.

Some have suggested that in vitro diagnostic companies could benefit from the proposed rule as it would level the regulatory playing field for these tests versus LDTs, and while the large majority of commenters affiliating themselves with the device industry were against the rule, there were indications of support among the IVD camp. Abbott, for instance, came out in support of the agency's proposal. Foundation Medicine, which has taken its FoundationOne CDx and FoundationOne Liquid CDx tests through the FDA, took issue with certain aspects of the proposal but said it supports "a single, risk-based regulatory framework for all tests."

Meanwhile, AdvaMedDx was generally supportive of the FDA efforts in its comment, though it noted that it continues to prefer and support the regulatory framework put forth in the Verifying, Accurate, Leading-edge IVCT Development (VALID) Act.

Insurer Blue Cross Blue Shield and insurer organization AHIP, which represents dozens of US health insurers including many of the country's largest payors, also came out in favor of the rule, with both arguing that the increasing complexity of LDTs means greater oversight is needed to ensure patient safety and effective care. Another likely consideration for insurers is that increased oversight could reduce usage and spending on LDTs.

Interestingly, managed care organizations Kaiser Permanente and Geisinger Health both came out against the rule, indicating that these companies view LDTs as, on balance, beneficial to their members and, presumably, their businesses. Both acknowledged the need to update the regulatory framework for LDTs but said that the proposed rule would disrupt their lab operations and negatively impact patient care.

The New York State Department of Health in its comment expressed support for increased federal oversight of LDTs and expressed hope that the state's Clinical Laboratory Evaluation Program (CLEP), which evaluates all LDTs offered for use in the state, could play a role in that oversight. It also provided some insight into CLEP's process and the performance of tests submitted to the state. According to the department, of applications submitted as of Sept. 30, 2021, 46 percent were approved based on the original application, while 33 percent of tests required a second round of review, and 20 percent of tests required more than two rounds of review. It said it encounters problems such as "analytical validity issues includ[ing] design flaws, inadequate validation data, and process problems that call into the question the reliability of the results."

Of the approximately 2,900 favorable comments, nearly all came from patients and consumers or patient and consumer advocacy groups stressing the need for more reliable testing. This includes the 2,844 form letter comments in which the posters identified themselves as "a patient and consumer."

Other patient and consumer groups that issued comments in favor of the rule include the Patient Consumer and Public Health Coalition, the Global Healthy Living Foundation, and the US Public Interest Research Group.

Laboratory and provider groups, meanwhile, were almost uniformly against the rule in their comments. Entities ranging from individual laboratory scientists and physicians to independent, hospital, and public health labs to industry and physician groups like the American Clinical Laboratory Association (ACLA), the National Independent Laboratory Association (NILA), the American Hospital Association (AHA), and the American Medical Association (AMA) overwhelmingly oppose the FDA rule.

These individuals and organizations expressed a variety of concerns, but in general, their opposition echoes many of the lab industry's longtime objections to FDA oversight of LDTs, including the agency's lack of legal authority to regulate these tests; flaws in its impact analysis of the proposed rule; the potential of FDA oversight to reduce patient access to needed testing and negatively impact patient care; the challenges FDA oversight may present to updating tests and test components as needed; and overlap with and duplication of existing regulations under CLIA.

Oncology is the one provider area that was somewhat an exception to this pattern. While a number of prominent cancer centers opposed the rule, and cancer diagnostic firms like Guardant Health and Invivoscribe registered reservations, the Association for Clinical Oncology (ASCO), the country's largest group of oncology providers, issued strong support for the proposed rule, arguing that FDA oversight of LDTs is "necessary to ensure the safety and effectiveness of LDTs used for directing critical treatment decisions" and noting that the organization has long advocated for FDA oversight of LDTs.

The American Cancer Society's Cancer Action Network also commented in favor of the rule, as did the Cancer Leadership Council and the National Brain Tumor Society.

Jeff Allen, CEO of advocacy group Friends of Cancer Research, which also issued a comment in support of the rule, said that the relative openness of the oncology community to LDT regulation is perhaps due to the fact that LDTs using newer, more complex technologies like next-generation sequencing and multi-biomarker assays have made deeper inroads into oncology than some other medical specialties.

"I could imagine that perhaps it is due in part to the complexity of the tests that are being developed," he said. "In oncology, we have seen that tests have become increasingly complex. There are emerging tests that are looking at composite scores of biomarkers, various different alterations that may be important to consider in determining the right treatments, and I think that is one reason this issue continues to receive attention."

Among laboratory scientists, Richard Burack, vice chair for clinical operations in the department of pathology and laboratory medicine at University of Rochester Medical Center, offered a rare dissenting opinion, commenting in favor of the FDA rule.

Contacted by GenomeWeb, he said that his experience complying with New York state's testing regulations left him confident his institution would be able to successfully navigate FDA oversight of LDTs.

Burack also said that he is skeptical that existing oversight is sufficient to ensure test quality and performance.

There are "great examples of widely marketed products in the United States [for which] there is significant awareness in the academic medicine communities about their shortcomings or their redundancy with already existing tests," he said.