See an excellent new five page analysis of potential weaknesses in FDA's arguments for its LDT regulating authority. By Stacy Amin, former FDA atttorney and now with Morrison & Foerster. (See a 2021 press release on Amin here.)
I asked Chat GPT 4 to assess the paper from the perspective of potential legal vulnerabilities of the FDA.
The author identifies several potential drawbacks and challenges to the FDA's plan to regulate laboratory-developed tests (LDTs). Here's a detailed summary focusing on those drawbacks:
Litigation Risks: The proposed rule is expected to provoke significant legal challenges, which could be some of the most interesting and precedent-setting ones the FDA has faced in decades (lines 96-98).
Regulatory Skepticism: There is currently a high level of skepticism toward government regulation, and the Supreme Court is reviewing cases that could affect the deference given to agencies like the FDA, which could influence how the FDA's new rule is received and upheld in courts (lines 101-111).
Reliance Interest: Laboratories may argue they have a reliance interest in the FDA's historical enforcement discretion, complicating the agency's efforts to change its policy. The courts' recognition of such reliance interests is still a developing area of law, adding uncertainty to the enforcement of the new rule (lines 120-136).
Historical Precedent and Major Questions Doctrine: The FDA has to counter arguments based on the "major-questions doctrine," which could challenge the agency's authority to regulate LDTs without clear congressional delegation, particularly in the absence of legislation like the VALID Act, which was not passed (lines 139-168).
Scope of FDA Authority: The clinical laboratory industry might argue that the Centers for Medicare and Medicaid Services (CMS) already regulate LDTs through CLIA, and that LDTs are a service rather than a product, thus outside of the FDA's purview (lines 185-193).
Costs and Benefits Dispute: Opponents of the rule may argue that the FDA has underestimated the costs and overestimated the benefits of the new regulation [*], as well as its ability to manage an influx of marketing applications. They might also argue that the current regulation by CMS and state regulators is adequate, making the new rule's additional costs unjustified (lines 208-218).
Support for the Rule: There is uncertainty about whether those who support the rulemaking have the resources and influence to defend it effectively, especially since previous efforts to pass similar legislation were unsuccessful (lines 226-232).
Forum Shopping: Litigants may seek courts that are historically more sympathetic to their cause, potentially bringing challenges against the FDA in courts that have a history of issuing nationwide injunctions against public health and safety-oriented rulemakings (lines 234-242).
These challenges highlight the complexity and potential difficulties in implementing the FDA's proposed rule on LDTs.
I (Bruce) wrote a white paper on these severely "overestimated benefits," October 10, here.