In the last couple weeks, I ran across a number of interesting articles from law firms about the FDA proposal to regulate lab developed tests - LDTs.
ESSAY #1
FDA LDT & LAW [Amin/Morrison & Foerster]
See also my blog November 10. This is an essay by Stacy Amin, a former FDA attorney, now at Morrison & Foerster. Amin's essay focuses on potential legal weaknesses of the FDA's proposal to regulate LDTs, and how the FDA has tried hard to preempt them rebuttals or justifications.
ESSAY #2
FDA SWOOPS INTO MCED [Mullen, Gibbs/Hyman Phelps Mcnamara]
This fits the "FDA LDT" topic because Mullen and Gibbs see the surprisingly sudden appearance of an FDA workshop on MCED, as tied to the FDA LDT rule. They note several oddities about the workshop. Good essay. "FDA Stealthily Convenes Multi-Cancer Testing Panel Meeting."
- Here.
ESSAYS #3,4,5
The Mullen/MCED essay includes three track-backs to prior essays about the LDT rule.
- The first simply introduces the FDA's land grab, by Cato, Mullen, Javitt on September 29.
- Here.
- The second is a livelier style and opens with the headline, "Raises Many Questions, Provides Few Answers." By Mullen, Javitt, Won, on October 6.
- Here.
- The third essay has the same topic as Stacy Amin's essay, the legal weaknesses of the FDA's position. "Would a Final Rule Withstand Judicial Scrutiny?" By Mullen, Javitt, et al, on November 2.
My Two Cents
I liked Mullen's tie-in of the rushed MCED workshop with the FDA LDT proposal.
In the same spirit, I'd add, the LDT proposal in September also has precedents in the FDA's June proposal to provide guidelines under which LDT cancer biomarkers could be considered equivalent to biomarkers used in clinical trials for a cancer drug. I think is because FDA knew it planned to declare LDT's illegal, yet the FDA also knew, that sometimes drugs are approved prior to their companion diagnostic That gap has hitherto been peacefully bridged by LDTs for the biomarker.
I think the FDA LDT proposal also ties to FDA's flip-floppy and messy actions over the legality of PGx software recently (see Genomeweb here.) FDA's new LDT proposal has no space for an FDA approved lab test coming from multiple locations (chemistry here, software there) as exists under some current CAP-CLIA models.
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AI Corner.
Chat GPT 4 provides us with its comparison of the Amin and the Mullen legal authority articles. GPT4 finds the Amin essay is more even-handed towards the FDA, the Mullen essay more skeptical. I read the Amin essay as also skeptical, but on review, I can see GPT-4's viewpoint that Amin carefully shows the FDA's rebuttals of each of its potential weaknesses. (On first reading, I probably judged those rebuttals as scanty, amd thus I judged the listing of weaknesses as the main point. In fact, as GPT-4 noted, the Amin essay is pretty balanced, more than I perceived at first reading).
Chat GPT 4:
The articles by Amin and Mullen offer differing perspectives on the FDA's proposed rule to regulate Laboratory Developed Tests (LDTs). Here is a comparison and contrast of their key points:
Similarities
Background of FDA’s Claim to Regulate LDTs: Both Amin and Mullen acknowledge the FDA’s historical claim that it has the legal authority to regulate LDTs as medical devices under the Federal Food Drug and Cosmetic Act (FD&C Act).
Proposed Rule Details: Each article outlines the FDA's proposed rule that aims to regulate LDTs like other medical devices, noting the shift from the agency's historical enforcement discretion policy.
Differences
Legal Basis and Challenges:
Mullen: Mullen focuses on the questionable legal basis for the FDA’s authority to regulate LDTs, highlighting the challenges and counterarguments against the FDA’s jurisdiction. This includes the historical failure of FDA-supported legislative efforts to amend the FD&C Act and the potential major questions doctrine challenge.
Amin: Amin emphasizes the FDA's effort to establish its jurisdiction over LDTs through historical evidence, suggesting that the agency has always asserted its authority in this area. Amin also discusses the potential major questions doctrine but in the context of supporting the FDA's position.
Scope and Impact of FDA Regulation:
Mullen: Highlights the economic and political significance of the proposed rule, hinting at potential overreach by the FDA and the major costs involved, as well as the possibility of broad legal challenges.
Amin: Discusses the evolving nature of LDTs and the FDA's justification for the rule based on public health concerns, including issues with false positives/negatives and inadequate validation studies.
Administrative and Legal Precedents:
Mullen: Raises concerns about the FDA’s potential overestimation of its authority and underestimation of challenges, referencing specific legal cases and doctrines that might be used to challenge the rule.
Amin: Focuses on the legal and administrative procedures the FDA has undertaken to strengthen its rulemaking, discussing the role of the major-questions doctrine and the agency's attempt to preempt arguments against its authority.
Public and Industry Reaction:
Mullen: Suggests a likely strong reaction from stakeholders against the FDA’s rule, including potential lawsuits and challenges based on the rule's economic impact and legal basis.
Amin: Notes the historical resistance to FDA regulation of LDTs and the intricate efforts the FDA has made to counter these arguments, acknowledging the potential for significant legal battles but focusing more on the FDA's preparedness and justification for the rule.
Implications and Predictions:
Mullen: Predicts that the proposed rule will lead to significant legal battles and scrutinizes the FDA’s legal standing and the potential impact of recent Supreme Court decisions on the agency's regulatory authority.
Amin: Also anticipates significant litigation but frames it in the context of a historic moment for the FDA, underscoring the importance of the rulemaking and the potential for precedent-setting outcomes.
Conclusion
While both articles recognize the significance of the FDA's proposed rule on LDTs and its potential to invoke major legal challenges, Mullen's article is more critical of the FDA’s legal standing and potential overreach, whereas Amin's article places greater emphasis on the FDA's historical assertions of authority and the public health implications of the rule.
