Legal Expert: Too early to tell if SCOTUS ruling will chill FDA regulation

Regulatory NewsRegulatory News | 09 August 2022 |  By 

Neil DiSpirito (Source: Brown Rudnick)

When the majority of the US Supreme Court (SCOTUS) in late June said that an Obama-era Environmental Protection Agency (EPA) policy to curb climate change was a regulatory overreach, legal experts wondered if it would have a chilling effect on the Food and Drug Administration’s (FDA) ability to regulate industry. According to a legal expert, it’s still too early to tell what the impact on FDA will be, though there are several areas where the agency may see challenges based on the court’s decision.
On 30 June, the high court ruled 6-3 in West Virginia v. EPA that the agency’s effort to fight global warming went beyond its legal authority. More specifically, Chief Justice John Roberts in the majority opinion wrote that under the Major Questions Doctrine, the EPA is not allowed to use regulations to affect major socio-economic-political issues which need to be addressed directly by the legislative branch. There have been concerns from pundits that it could have a chilling effect on other federal agencies, including FDA.
“I don't think it's quite as bad as it seems,” Neil DiSpirito, an FDA legal expert with the law firm Brown Rudnick told Regulatory Focus. “As John Roberts said, if Congress wishes to affect the sweeping overhaul of the nation's economic activity, it must do so quite explicitly with clear Congressional authorization.”
“Agencies may not on their own initiate or transform a statutory scheme used for one thing to perform some other ambitious work, even if the law’s language makes their statutory interpretation tolerable,” he added.
DiSpirito also said that there could be some cases brought against FDA using the Major Questions Doctrine but it may take another three to six months before such challenges are filed. He also noted that there’s a lot of ambiguity and subjectiveness around what “major” means.
DiSpirito said there are certain enumerated authorities that FDA has acquired over the years from Congress outside of its traditional authority to protect public health. One example is the agency’s ability to allow COVID-19-related products on the market through emergency user authorization (EUA) under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
But there are other areas that FDA has shown interest in that under the recent EPA ruling the agency would clearly need Congressional authority such as the authority to regulate laboratory-developed tests (LDT).
FDA has long argued that as LDTs have become more complex to diagnose more dangerous diseases, and as companies have mass-manufactured LDT kits and marketed them across state borders, the agency needed to regulate them beyond what is required under the Clinical Laboratory Improvement Amendments (CLIA). The agency even developed a plan to use a risk-based approach to start regulating LDTs in the final days of the Obama Administration but then pulled the plug on the idea when President Trump came to power.
Since then, former FDA commissioners such as Scott Gottlieb have argued that while LDT regulation is warranted, the agency needs explicit legal authorities from Congress. DiSpirito says that it’s clear now the current Supreme Court would consider the agency regulating LDTs under the previous plan an overreach of its regulatory authority.
“Some [district and appellate] courts would say their mandate is to protect public health so they would give them much more latitude but this [Supreme Court] would say Congress would have to explicitly give them the mandate,” he said. “Under this court, that may be one that's challengeable, especially given the West Virginia decision.”
DiSpirito also notes there are other scenarios that may be affected by the court decision such as FDA’s authority to encourage wider use of Narcan (naloxone) to prevent opioid overdose deaths. He says while many states allow people to buy the drug without a prescription as part of their efforts to fight the opioid crisis, the drug is not available over-the-counter (OTC).
While FDA may consider changing the status of the drug to an OTC, it can’t do so without manufacturers filing an application to make that status change. The agency may argue that under the regime that it has to allow COVID-19 EUA products on the market, it also has the authority to address the opioid crisis under its public health authority.
“In a public health crisis, such as the one we’re having with opioids, could the FDA force the switch [from prescription to OTC],” DiSpirito asked. “Well, according to the Supreme Court decision in West Virginia, not necessarily. That would be using one statutory regime to support another.”
DiSpirito has been looking at court filings to see if anyone has used the West Virginia decision to come after FDA but so far he hasn’t seen anything. Considering that it’s been just over a month since the ruling was handed down, he says it may just be a matter of time before challenges citing the ruling emerge.
Other areas where DiSpirito thinks companies may come after FDA using the court ruling include the agency’s recent regulations of e-cigarettes, though DiSpirito says much of that has already been litigated in the 2000 FDA v. Brown & Williamson SCOTUS case and the agency already has certain enumerated authorities under the Tobacco Control Act.
FDA may also get pushback on its use of video to inspect manufacturers during the COVID-19 crisis which it is considering keeping even after the pandemic.
“Nowhere in the 1938 [FD&C] act does it say that the FDA can use video inspection,” notes DiSpirito. “It says they have the right to inspect, and the rules promulgate about the inspectors arriving, presenting their credentials during normal business hours, and inspecting a company in a certain manner.”
Similarly, companies have complained FDA inspections go beyond what the agency is allowed by statute that could also be challenged using the recent SCOTUS decision. Other issues that may similarly be challenged include the agency’s request that companies provide additional manufacturing information to prevent product shortages, cybersecurity requirements so that connected medical devices can maintain a high level of security, and steps the agency is trying to take to ensure companies don’t try holding back other generic drugs from getting on the market.
DiSpirito says that discretion is going to be a major issue because while the court ruling states there are certain things that Congress needs to authorize federal agencies to do, it also states there are certain issues that it can not delegate to federal agencies and needs to address itself.
Ultimately, DiSpirito says the problem is that there’s a lot of ambiguity with defining words such as major question, major economic and political, and major regulatory needs that have an impact on the public.
“The problem we have there is who decides that,” said DiSpirito, “Are the lower courts going to use West Virginia to kind of stifle regulation? There's a lot of discretion involved there. That's what could have a chilling effect on agencies because who's to define what ‘major’ is.”


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