FDA Watch: How Could the End of Chevron Impact the FDA and LDTs?

The key to laboratories being able to successfully challenge the U.S. Food and Drug Administration (FDA) over its move to regulate laboratory-developed tests (LDTs) as medical devices might be linked to three commercial herring fishing businesses.

Those businesses challenged fees charged by the National Marine Fisheries Service to carry observers on their boats to ensure they were abiding by fishery conservation regulations. Their lawsuit reached the Supreme Court of the United States (SCOTUS) last year, and resulted in it overturning the so-called “Chevron deference” in late June.¹

The Chevron deference stems from a case decided by the nation’s highest court in 1984. That litigation, Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., led to the Supreme Court ruling that federal agencies have the leeway to interpret any regulatory rules that are considered ambiguous.

In the decades since that decision, the Supreme Court has moved much further to the right politically. That move, combined with a decidedly anti-regulatory bent, has led it to undo numerous legal decisions that have been on the books for decades, including the Chevron deference.

The high court’s decision released June 28 in Loper Bright Enterprises v. Raimondo ruled that the Chevron deference violated the Administrative Procedure Act of 1946. As a result, any battles over ambiguous regulatory rules may be taken to federal court for decisions.

What overturning Chevron may mean for the FDA

“Under Chevron . . . the FDA would be able to establish a ‘preferred interpretation’ [of a regulation] and all courts looking at the issue would have to defer to this interpretation,” said Heather Pearson, a regulatory attorney with the firm Bass, Berry & Sims PLC in Washington, DC, in an email.  “Arguably, this . . . would allow for consistency across the regulatory landscape. Because Loper ended this deference, it will now be up to each individual judge . . . to assess what Congress actually meant when it passed a particular law.”

That also means how the FDA regulates LDTs could come under judicial scrutiny, and that judges would have to decide what, according to the Supreme Court decision, “Congress meant when it granted the FDA the authority to regulate ‘medical devices.’”

The decision also states that the Chevron deference may be replaced by what is known as the “Skidmore” deference. This deference stems from a 1944 Supreme Court case where the justices concluded that courts could rely on a federal agency’s decisions made in good faith and based on specialized experience “to which courts and litigants [could] properly resort for guidance.”

However, Pearson noted that the Skidmore deference still gives far more leeway to courts than agencies in the decision-making process. “Unlike Chevron, which required a court to defer to an agency’s interpretation of its own ambiguous statute, Skidmore provides more room for a judge to independently assess the reasons behind an agency’s proposed interpretation,” she said.

How this unfolds for the FDA and laboratories in the coming years remains to be seen, but it is likely to provide some advantages to the sector as it presses legal battles over LDT regulation. The American Clinical Laboratory Association (ACLA) filed a lawsuit in May challenging the FDA’s issuance of a rule allowing the agency to regulate LDTs as medical devices.

“FDA’s Final Rule is the wrong approach, both as a matter of law and public policy, and represents regulatory overreach,” said ACLA president Susan Van Meter at the time the lawsuit was filed.² “The medical device framework is inappropriate and ill-suited for regulating laboratory-developed tests, which are services provided by trained professionals rather than manufactured products.”

Laboratory associations respond to SCOTUS decision

An ACLA spokesperson declined to comment about the potential impact of the Loper decision on its lawsuit, which was filed in federal court in Texas, where some of the most anti-regulatory judges in the federal judiciary preside.

The Association for Diagnostics & Laboratory Medicine (ADLM) issued a statement four days after the Loper decision to praise a letter Sen. Bill Cassidy, a Louisiana Republican and physician, sent to the FDA asking how it intends to implement its regulatory framework in light of the decision.³

Cassidy’s letter to FDA commissioner Robert Califf, MD, remarked that “overturning the deference that FDA receives when interpreting statutes does not mean that courts will disregard FDA’s expertise. Instead, courts will now give FDA’s know-how appropriate consideration, yet reclaim their constitutional role of interpreting laws without putting a thumb on the scale in favor of the agency.”⁴

However, Cassidy added that “given your agency’s track record, I am concerned about whether and how FDA will adapt to and faithfully implement both the letter and spirit of this decision. For example, FDA has unilaterally asserted jurisdiction over laboratory-developed tests . . . without Congress granting FDA that authority.” Cassidy, who is ranking member of the Health, Education, Labor and Pensions Senate Committee, asserted that Congress never gave the FDA the power to regulate LDTs.⁴

“ADLM…strongly supports Rep. Cassidy’s letter to the FDA, and we appreciate that he asks the agency in great detail how it plans to change its current practices to enforce the laws as Congress writes them, instead of improperly legislating via agency action. We look forward to the FDA’s answers to Rep. Cassidy’s questions,” said ADLM president Octavia Peck Palmer in a statement. “In particular, we hope the agency will take this opportunity to halt its laboratory-developed tests rule.”³

References:

1. https://www.supremecourt.gov/opinions/23pdf/22-451_7m58.pdf
2. https://www.acla.com/acla-challenges-fdas-final-rule-to-regulate-laboratory-developed-testing-services-as-medical-devices/
3. https://www.myadlm.org/Media/Press-Release-Archive/2024/07-July/ADLM-supports-Rep-Cassidy-letter-asking-the-FDA-how-it-will-abide-by-recent-Supreme-Court-decision
4. https://www.help.senate.gov/imo/media/doc/loper_bright_letter_fdapdf.pdf

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Key laboratory test approvals in the past month by the FDA include the following decisions:

New CE Marks and Global Certifications

No significant EU or global approvals were announced during the period.