HP&M Files Comments Opposing FDA’s Proposed LDT Rule

December 7, 2023By Jeffrey N. Gibbs & Gail H. Javitt

On Monday, Hyman, Phelps & McNamara, P.C. filed comments on behalf of the Coalition to Preserve LDT Access and Innovation in response to FDA’s proposed rule to regulate laboratory developed tests (LDTs) as devices.  Weighing in at nearly 60 pages, the comments detail extensive flaws in the proposed regulation.  We’ve previously written about this proposed rule (see here, here, and here) which would transform the diagnostic market in the United States.

As a threshold matter, FDA lacks the power to regulate tests developed and used in a laboratory.  The Federal Food, Drug, and Cosmetic Act simply did not confer that power upon FDA.  Congress has, on multiple occasions, considered legislation that would have given FDA that authority, but it never did so.  FDA cannot now unilaterally assume power that Congress chose not to confer in the first instance.

FDA tries to justify the proposed rule by claiming that LDTs present significant risks, and that the solution is to regulate them all as medical devices.  The support FDA offers for its proposition – which comes from a mixture of sources, including a few published scientific articles, newspaper stories, FDA’s experience with LDTs with COVID, anecdotes, older case studies, and class action lawsuits – is singularly unconvincing.  For example, one of the primary articles cited by FDA to show poor laboratory performance of LDTs has been the subject of a reanalysis by the College of American Pathologists that found “excellent laboratory performance” of molecular oncology proficiency testing for cancer-associated genetic variants.  Similarly, a newspaper article cited by FDA, which asserted risks from Non-Invasive Prenatal Testing, was rebutted by multiple peer-reviewed studies and is at odds with the conclusion reached by medical professionals, such as the American College of Medical Genetics.  Although the sources cited by FDA differ, there is a common denominator: FDA never acknowledges the existence of contrary evidence.

The proposed rule similarly ignores the benefits of LDTs.  Tests such as genetic testing of prospective parents, prenatal screening, cancer prognosis, and testing for rare diseases play a critical role in the health care system.  Reading the proposed rule, one would never know why LDTs even exist, since there is no reference to their benefits.  Similarly, there is no recognition of the harm that would occur if many of these tests were to vanish because laboratories cannot sustain the significant economic burdens resulting from the new regulatory requirements.

FDA’s assessment of the costs of regulating LDTs as devices is similarly problematic.  The agency’s Preliminary Regulatory Impact Assessment (PRIA) repeatedly either understates the costs of certain tasks or ignores them altogether.  For example, in FDA’s “primary” case, laboratories would be expected to spend eight hours a year on management reviews.  That projection is ludicrously low, and one can only wonder how FDA could expect a compliant company to spend so little time on this function.  The PRIA also omits entire other categories of costs, such compliance with 21 C.F.R. Part 11, the need to hire new laboratory personnel, and engage outside experts such as Contract Research Organizations, biostatisticians, lawyers, and software engineers.

Although the proposed rule cites FDA’s reports of allegedly flawed Emergency Use Authorizations for COVID-19 tests submitted by labs – a complaint that ignores the extraordinary and non-representative circumstances presented by COVID – FDA apparently has developed its own post-COVID brain fog concerning the Agency’s inability to handle the deluge of EUAs during the course of the pandemic.  And yet, under the proposed rule, FDA is expecting a far greater surge, for a longer period of time, of far more complicated submissions.  Based on the COVID experience, this is a recipe for gridlock and chaos. FDA seems unconcerned by this prospect.

In sum, we think the proposed rule is a mistake.  But don’t take our word for it in this summary; read the other 6,731 comments submitted to FDA’s docket.   Speaking of which, given the statements FDA has made to date, we fully expect FDA to issue a final rule; while we cannot predict when, one press report predicted it could happen as soon as May 2024. Although the Administrative Procedure Act requires a federal agency to review and carefully consider all comments, it is inconceivable that FDA could read, let alone reflect on, this volume of comments within that timeframe.  Nevertheless, whenever the final rule is issued, there is very likely to be litigation.  For the reasons laid out in our comments, as well as the many others that objected to FDA’s proposal, the comments filed with FDA will provide plaintiffs with numerous bases for judicial challenge.