Friday, September 29, 2023

Sidebar 1: FDA Legal Justification for LDT Regulation

On September 29, 2023, FDA released proposed regulations that would allow it to regulate lab developed tests.   See my discussion in a previous blog:

The FDA provides a 5000-word legal justification (Part IV, legal justification, is only a paragraph to restate statutory authorities, but other parts of III and V have extensive legal expositions, often with numerous court cases cited).  

  • But recall that there are other arguments FDA just can't do this - See Genzen; see Clement and Tribe.
  • Recall that the Trump administration forbid FDA to regulate LDTs ...and the Trump administration could be back.  

For one exampole of FDA's legal adventures (p 43), FDA says that "few have argued" that a "modern" interpretation of the interstate commerce clause allows the FDA to regulate purely intra-state activities. Then FDA embarks on an affirmative discussion of the commerce clause in deference to those few naysayers.  FDA says the FDA act as a whole doesn't require interstate commerce explicitly, but only a "constitutional minimum" applies to most of it. FDA Says are very few, and specific points, where the FDA act remarks on interstate commerce "elements," but these are generally not germane to devices.

Some of the FDA's arguments depend on precedents that are subject to change at the Supreme Court.  For example, yes, FDA writes that few doubt that interstate commerce can include FDA's authority to regulate solely intra-state activities.  But a near-future SCOTUS might say that "interstate commerce" means what it would have meant to Ben Franklin, something put in a crate and shipped  over a state line.  And while FDA states that "interstate commerce" actually has nothing to do with its power to regulate LDTs, this seems a little shakier when the FDA Act itself repeatedly refers to, "interstate commerce."     

With that said...

 I am not an attorney, and neither is Chat GPT, but here is a GPT summary of the legal section.


The FDA's legal justifications for its lab test policy can be analyzed in detail as follows:

IV.  Regulatory Framework for Lab-Developed Tests (LDTs):

The FDA argues that LDTs are subject to its regulatory authority based on the existing legal framework. The key points supporting this argument include:


Existing Law

a. Statutory Authority: The FDA asserts that its authority to regulate LDTs is derived from the Federal Food, Drug, and Cosmetic Act (FD&C Act), which grants the agency jurisdiction over medical devices. It contends that LDTs qualify as medical devices, as they are designed and used for medical purposes, and therefore, fall within the scope of FDA regulation.

b. Historical Perspective: The FDA highlights that it has exercised jurisdiction over in vitro diagnostic (IVD) devices, including LDTs, for many decades. This historical practice is seen as consistent with the agency's interpretation of its statutory authority.


Functional Equivalence:

The FDA argues that LDTs are functionally equivalent to commercial IVDs. This equivalence is a key aspect of the FDA's justification for regulating LDTs. The main points include:

a. Similar Technology: The FDA emphasizes that LDTs often employ the same technology, instruments, and software as commercially available IVDs. It contends that the core function of both LDTs and commercial IVDs is to analyze patient samples and provide diagnostic information.

b. Development Teams: The FDA highlights that even LDTs developed in laboratories often involve specialized teams with expertise in bioinformatics, software development, and medical genetics, similar to commercial IVD development teams. This suggests that the technical aspects of LDTs are on par with commercial IVDs.

c. Clinical Validation: The FDA argues that clinical validation and design activities are critical aspects of ensuring the safety and effectiveness of both LDTs and commercial IVDs. These activities, it asserts, fall under its regulatory purview.


CLIA and Laboratory Role:

The FDA acknowledges that laboratories play a distinct role in diagnostic testing, particularly in the performance of tests. However, it argues that this role does not exempt laboratories from FDA jurisdiction when they are involved in manufacturing test systems. Key points in this regard include:

a. CLIA Certification: While laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) are authorized to perform high-complexity testing, the FDA contends that this does not absolve them of their obligations under the FD&C Act when manufacturing test systems. It asserts that CLIA governs the testing process, while the FD&C Act governs the manufacturing of test systems.

b. Practice of Medicine Provision: The FDA addresses the "practice of medicine" provision in the FD&C Act and argues that it is limited in scope. Section 1006 of the FD&C Act is seen as protecting the authority of healthcare practitioners to prescribe or administer legally marketed devices within a legitimate practitioner-patient relationship. It is emphasized that this provision does not extend to the manufacturing of new test systems.


Impact of Other Legislation:

The FDA refutes the notion that other legislation, such as CLIA, supersedes its authority over LDTs. It argues that CLIA and the FD&C Act have distinct focuses and purposes and are intended to complement each other. This perspective is based on the premise that CLIA primarily addresses proficiency in clinical testing, while the FD&C Act covers various aspects, including clinical validation and design activities.


Interstate Commerce and Commercial Distribution:

The FDA addresses the arguments related to interstate commerce and commercial distribution, asserting that these elements do not significantly affect its jurisdiction over LDTs. Key points include:

a. Interstate Commerce: The FDA points out that the FD&C Act does not require all devices to have a specific nexus with interstate commerce beyond the constitutional minimum. While some provisions include interstate commerce elements, they are not universal, and the absence of such elements does not diminish the FDA's jurisdiction over devices, including LDTs.

b. Commercial Distribution: The FDA contends that LDTs are indeed intended for commercial distribution, and the phrase "for commercial distribution" is interpreted to mean "on the market." It asserts that LDTs, like other medical devices, are available for commercial use and are therefore subject to FDA regulation.

In summary, the FDA justifies its regulatory authority over LDTs based on its interpretation of the FD&C Act, historical practices, functional equivalence with commercial IVDs, and the distinct roles of CLIA and the FD&C Act. It also addresses arguments related to interstate commerce and commercial distribution, asserting that they do not alter its jurisdiction. These legal justifications form the foundation of the FDA's policy regarding LDTs and its efforts to ensure their safety and effectiveness.



The above summarized the FDA's writings.

Next, we ask Chat GPT to analyze rather than just summarize.


Are any of these arguments weaker than others?   For example it regulates devices "introduced into commerce" and the "Device" (the lab developed test in its lab) is hardly "shipped" into interstate commerce.   It says that the lab's authority to offer LDTs under CLIA "does not absolve" it of FDA regulation, but maybe it does.   Discuss and use other issues and examples as appropriate.


Certainly, within the FDA's legal justifications for its lab test policy, some arguments may be perceived as weaker than others. It's important to note that the strength of these arguments can be a matter of interpretation and legal analysis. Here are some aspects where certain arguments might be considered weaker:

Interstate Commerce Argument:

The argument that the FDA's jurisdiction hinges on devices being "introduced into commerce" can be seen as relatively weaker in the context of LDTs. This is because, as you mentioned, LDTs developed and used within a single laboratory may not involve the same level of commercial activity or "shipment" as traditional medical devices.

Counterargument: Opponents may argue that the "introduced into commerce" requirement implies a more significant connection with interstate commerce than what is typically associated with LDTs developed and used within the confines of a single laboratory. They might contend that LDTs should be treated differently due to their localized nature and the absence of traditional commercial distribution.

CLIA Authority Argument:

The argument that CLIA certification does not absolve laboratories of FDA regulation could be subject to debate. While the FDA asserts that CLIA and the FD&C Act serve distinct purposes, some may argue that the authority granted under CLIA should carry more weight, especially in cases where CLIA-certified laboratories are operating within the scope of their certification.

Counterargument: Opponents might point out that the CLIA framework is specific to clinical laboratory practices and standards. They may argue that laboratories operating within the confines of their CLIA certification should have some degree of exemption or flexibility from FDA regulation, particularly for LDTs that are developed and used exclusively in a clinical laboratory setting.

Commercial Distribution Interpretation:

The FDA's interpretation of "commercial distribution" as meaning "on the market" may face scrutiny. Some may argue that this interpretation could be too broad, potentially encompassing activities that do not involve traditional commercialization.

Counterargument: Critics could contend that the FDA's interpretation of "commercial distribution" should be more narrowly defined to exclude LDTs developed and used within a single laboratory. They might argue that the mere availability of a test within a laboratory's own practice should not trigger FDA regulation based on a broad interpretation of commercial distribution.

Historical Practice:

The FDA's reliance on historical practice to assert jurisdiction over LDTs may be challenged. Critics might argue that historical practice should not necessarily dictate current regulatory decisions, especially as technology and healthcare practices evolve.

Counterargument: The FDA could counter this by asserting that historical practice reflects a longstanding interpretation of the law and that the agency's actions are consistent with the FD&C Act's original intent. They may argue that established regulatory frameworks provide stability and predictability in the industry.

In summary, the perceived strength or weakness of these arguments depends on one's legal interpretation and perspective. Opponents of the FDA's regulatory approach to LDTs are likely to focus on areas where they believe the agency's rationale is less compelling, such as the interpretation of interstate commerce, the relationship between CLIA and the FD&C Act, or the definition of commercial distribution. Legal challenges and ongoing debates in this area will continue to shape the regulatory landscape for LDTs.