Saturday, July 6, 2024

Trade Journals Headline the "UNCERTAINTY" of FDA LDT policymaking

Within a few days of each other, both 360DX and CAPTODAY feature articles on FDA LDT regulation, and the headlines announce, "UNCERTAINTY" and "UNKNOWNS."

Here is the June 26 article at 360DX by Adam Bonislawski [subscription]:

Here is the July article at CAP TODAY by Karen Titus [open access]:


Neither article directly calls out the presidential election, and if we just say neutrally that DJT has a low end 25% and high end 75% [The Economist this week] odds of winning, that's a big wild card.  


On an exploratory note, in May, I wrote a blog how labs could reckon with a huge ruling that could, however, be "canceled, changed, or delayed."  The blog was based on feeding key facts and scenarios to Chat GPT 4.  Here.


AI Corner

For curiousity only!  I have not fact-checked this but it gives an idea of verbal reasoning that AI is on the path to doing.   (Similarly, a few days ago I asked Chat GPT to pull out and cluster groups of related tests from the new AMA PLA codes, which are numbered randomly).

So, for an unvalidated skim, here's the result.  If I actually needed this, I could use the AI as a starting point but validate it point by point against the 2 articles.   Without validation, as here, just for fun.


[Chat GPT 4 ]  Here is a reasoned analysis of the two articles by Adam Bonislawski and Karen Titus regarding the uncertainty surrounding the FDA's regulation of laboratory-developed tests (LDTs):

1. Facts or Situations Mentioned by Both Authors:

  • FDA Final Rule on LDTs: Both articles discuss the FDA's final rule regulating LDTs as medical devices, highlighting the phased approach for implementation and the mixed reactions from the laboratory community.
  • ACLA Lawsuit: Both articles mention the American Clinical Laboratory Association (ACLA) filing a lawsuit against the FDA, arguing that the FDA does not have the authority to regulate LDTs as medical devices.
  • Enforcement Discretion: Both articles highlight the FDA's use of the phrase "exercise enforcement discretion," indicating the agency's flexibility in enforcing the new regulations and its intention to issue further guidance.
  • Industry Concerns: Both articles address the concerns of the laboratory community regarding the increased regulatory burden, potential impact on lab operations, and the need for clarification on various aspects of the final rule.

2. Facts and Situations Mentioned Only by Adam Bonislawski:

  • Legal Landscape and Chevron Doctrine: Bonislawski's article delves into the broader legal landscape, discussing the potential impact of the Supreme Court's reconsideration of the Chevron doctrine on the FDA's authority and regulatory actions.
  • Specific Legal Arguments: The article by Bonislawski provides detailed insights into the legal arguments presented by the ACLA, including the contention that LDTs are professional healthcare services, not medical devices, and the historical context of the FDA's regulatory authority.
  • Carve-Outs and Regulatory Response: Bonislawski discusses the various carve-outs included in the FDA's rule and how they were established in response to public comments. He also touches on the potential vulnerabilities these carve-outs might introduce to the FDA's legal position.
  • District Court for the Eastern District of Texas: The article mentions that the ACLA filed its lawsuit in this specific court, which has historically been more receptive to arguments of regulatory overreach, indicating a strategic choice by the ACLA to potentially delay the implementation of the rule.

3. Facts and Situations Mentioned Only by Karen Titus:

  • Lab Responses and Preparations: Titus provides specific examples of how laboratories, such as those at Duke University Medical Center, responded to the release of the final rule, including efforts to validate LDTs before the rule took effect.
  • Stakeholder Reactions: The article includes reactions from various stakeholders, such as Jane Pine Wood and Dr. Diana Cardona, who provide detailed commentary on the implications of the rule for lab operations, the potential impact on patient care, and the challenges of navigating the new regulatory environment.
  • Impact on Digital Pathology and AI: Titus's article specifically addresses concerns about the impact of the FDA's rule on digital pathology and the integration of artificial intelligence in lab tests, highlighting the regulatory uncertainties and potential hesitations in adopting new technologies.
  • Economic and Operational Burdens: The article discusses the economic and operational burdens imposed by the new regulations, including the need for labs to hire additional staff or create new positions to manage compliance and validation processes.

By analyzing both articles, it is clear that while they cover similar ground regarding the FDA's final rule on LDTs and the ACLA's lawsuit, they offer unique perspectives and additional details that complement each other. Bonislawski's article focuses more on the legal and regulatory framework, while Titus provides a closer look at the practical and operational challenges faced by laboratories. 

[END Chat GPT]