FDA’s lab-developed testing rule could be first check on agency power post-Chevron

The recent U.S. Supreme Court’s landmark decision overturning the Chevron Doctrine could open the door to further challenges to Food and Drug Administration regulations, particularly the agency’s controversial rules on laboratory-developed tests.

In late June, the Supreme Court ruled 6-3 Upending Decades of History at Chevron The deference principle means that courts no longer have to defer to federal agencies’ interpretations of vague laws passed by Congress. Roper Bright Enterprises v. Raimondo and Relentless Corp. v. Department of Commerce, Although it concerned monitoring requirements for fisheries, it could have far-reaching effects across federal agencies.

“This is a broad-based decision that will come in many different forms, many of which are unpredictable,” Jeff Gibbs, a director at the Washington, D.C.-based law firm Hyman, Phelps & McNamara, said in an interview with MedTech Dive.

Gibbs added that the decision will have implications for the medical device industry, saying the ongoing litigation challenging the FDA’s final rule on LDTs ​​could be “kind of a bellwether” of how the Chevron turmoil might affect the FDA.

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“This is a broad-based decision that will manifest itself in many ways, many of which we cannot predict.”

Jeff Gibbs

Director Hyman Phelps McNamara

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An FDA spokesman said the agency remains confident in its regulations, guidelines and the legal basis for its decisions.

“We continue to act based on science and in accordance with federal law and regulatory guidance,” the spokesperson said in an email.

The court’s decision is “very important for the FDA,” the former FDA commissioner said. Scott Gottlieb writes: Gottlieb wrote that while the court will still defer to the FDA for product review decisions, some areas involving the FDA’s final decision could be immediately affected. Rules for LDT.

LDT is an “early warning sign” of the Chevron effect

Early indications are expected as to how the Supreme Court’s Chevron decision will apply to the regulation of LDTs.

For decades, the FDA has treated LDTs ​​with enforcement discretion, meaning it has not required most laboratory-developed tests to comply with medical device regulations, such as premarket review, device registration, labeling standards, and adverse event reporting.

On May 6th, everything changed. Published the final rule The bill would significantly expand oversight of LDTs ​​and place them under the same regulatory framework as other in vitro diagnostics. The FDA pushed ahead with the plan despite strong opposition from the testing industry, because the agency believes that since it initially took a less stringent approach to regulating LDT tests, risks have increased associated with increasingly sophisticated and widely used tests.

Critics of the new regulations Blamed the agency Less than a month after the final rule was issued, the American Clinical Laboratory Association (ACLA) wrote in a statement that the FDA had exceeded its statutory authority to define LDTs ​​as medical devices. Sued the FDA The ACLA, which includes LabCorp, Quest Diagnostics and other test developers, filed a lawsuit in the U.S. District Court for the Eastern District of Texas seeking to invalidate the rule. They argue that Congress never gave the FDA the authority to regulate the provision of testing services by clinical laboratories.

Legal experts said the Supreme Court’s decisions overturning the Chevron deference standard in Roper and Relentless will influence the Court’s review of future ACLA challenges.

“I have no doubt that Roper and Relentless will play a major role in this case,” said Rebecca Wood, a partner at Chicago law firm Sidley and a former chief counsel for the FDA. “The FDA will not necessarily lose, but it will have a lot less respect than it had before these rulings.”

Wood said that if the Chevron case is overturned, the FDA’s positions on science, technology and regulatory policy will likely continue to be respected, but the ruling may make it harder for the FDA to win such cases.

It remains to be seen whether testing companies and laboratories will file further lawsuits against the LDT regulations in the wake of the Supreme Court’s decision. “They may just prefer to wait it out in this particular case,” Wood said.

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“It’s not that the authorities will necessarily lose, but there will be a lot less respect for them than there was before these decisions were made.”

Rebecca Wood

Sidley Partners

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Some believe the FDA will face more backlash over its decisions in general, and in particular over decisions that involve interpreting the scope of its authority under the Federal Food, Drug, and Cosmetic Act.

“The courts have been clear that they don’t have to give the FDA deference when it comes to issues of statutory interpretation,” said Greg Levine, a partner at the Boston law firm Ropes & Gray. Levine added that “industry participants, manufacturers and other interested parties will be less hesitant to challenge the FDA.”

Meanwhile, the FDA will likely need to spend more time thinking about the basis for its decision and provide justification that could withstand challenge in court.

“This would inevitably delay FDA policymaking and rulemaking,” Levine said.

Another recent Supreme Court decision could cause the FDA to face further challenges by allowing people to sue six years after an FDA action harmed a plaintiff, regardless of when the action occurred.

“That’s a pretty powerful combination in terms of the FDA’s vulnerability to legal challenges,” Levine said.

Implementing LDT rules

Meanwhile, test developers, especially those who do not yet manufacture medical devices and are not accustomed to complying with the FDA’s current Good Manufacturing Practice regulations and other requirements, are transitioning to the new standards.

“We’re certainly seeing clients who believe this rule applies to them,” Sidley’s Wood said.

Saganth Pillay, global medical director of oncology at Illumina, a San Diego-based gene-sequencing company, said the lab is doing its best to comply with regulations.

“The general feeling is that because this is a government requirement it should be complied with,” Pillay said.

As a longtime lab equipment manufacturer, Illumina already complies with quality management system requirements and understands the processes involved, Pillay said, adding that the company is prepared to act as a resource for its lab customers and use its experience to help them navigate the changes brought about by the FDA’s new rules.

Revival of the VALID Act?

Parliament has been The bill could not be passed. The bill, known as the Validation of Accurate, State-of-the-Art IVCT Development (VALID) Act, would clarify the regulatory framework for laboratory-developed tests by amending the Federal Food, Drug, and Cosmetic Act.

In the absence of legislation addressing the FDA’s role in regulating LDTs, the agency has pursued the rulemaking process, citing the need to ensure the safety and effectiveness of tests that range from screening newborns to predicting cancer risk. Manu Dabar, a partner at Washington-based Arnold & Porter who specializes in life sciences, said that while Congress has been reluctant to expand the agency’s authority, there may be agreement that legislative fixes would provide a clearer path for LDTs ​​now that the Chevron decision has been overturned.

“We hope this will be an opportunity for the parties to come together again and urge Congress to act in this area,” Davar said.

FDA may face more lawsuits after Chevron case

Lawyers expect the FDA to face further litigation following the recent Supreme Court decision, but the agency’s authority to approve, license and recall products is likely to remain intact.

Former Acting US Attorney General Stuart Gerson expects “many more cases” to be filed between the two decisions, and he also expects to see more “forum shopping” between courts, where courts target specific jurisdictions to obtain favorable decisions.

“We are entering uncertain times,” he said. “There will be more disputes because the ways in which disputes can be brought have been strengthened.”

But not all challenges to FDA policies will be successful: Courts will turn to government and private experts on technical issues, but agencies are more likely to be respected if they maintain consistent positions over time, Gerson said.

Ropes & Gray’s Levine said decisions that apply to the FDA’s scientific expertise, such as device approvals and licensing, will likely remain difficult to challenge in court, and he doesn’t expect the agency’s recall oversight to be affected for similar reasons.

The FDA may face further backlash in regulating artificial intelligence and software as a medical device because of ambiguity about how the software fits into existing regulations.

The 21st Century Cures Act: Software functions can also be medical devices“There are difficult questions around what types of software are regulated devices and what types of software are not,” Levine said.

In 2022, the FDA Final Guidance on Clinical Decision Support SoftwareClarifies when certain software features should be regulated as medical devices. This guidance: Backlash from industry groups The types of software that are regulated as medical devices have been expanded to include tools that analyze patient information to detect possible strokes or sepsis, something that previously escaped FDA oversight.

“It’s very vague,” said James Ravitz, a partner at Chicago-based law firm McDermott Will & Emery. “It’s like saying, ‘I’m not a medical device.'”

But he added that the issue is not currently generating as much industry heat as LDT.

Lawyers expect the Supreme Court’s decision will have little day-to-day impact on medical device makers, with Hyman Phelps’ Gibbs predicting “very few” legal challenges on issues as significant as LDT.

“Suing the U.S. government isn’t cheap,” Rabbitt said. “It would take a coalition to come together.”