The Supreme Court’s decision late last month to overrule a decades-old legal doctrine will have major ramifications for the FDA and the biopharma industry it regulates.
Legal scholars warn that the move by SCOTUS could lead to more uncertainty for the pharma industry, more challenges to FDA approval decisions, more guidance documents (rather than rulemakings), and likely more new legal disputes.
This week, House Republicans, led by Reps. James Comer (R-KY), chair of the House Oversight Committee, and Jason Smith (R-MO), chair of the Ways and Means Committee, sent a letter to HHS seeking lists of all rulemakings that might be impacted by the Supreme Court decision, known as Loper Bright Enterprises v. Raimondo. The letter seeks everything from guidance documents to enforcement actions brought by the department in court since January 20, 2021.
What might be affected? Experts pointed to the recent example of proposed FDA regulations for lab-developed tests. The agency’s latitude in interpreting the law has been challenged and may be further challenged. The House Appropriations Committee this week even went so far as to instruct the FDA to “suspend its efforts to implement the rule and continue working with Congress to modernize the regulatory approach for LDTs.”
Others have said the Chevron ruling could lead to more guidance from the FDA as the agency may now look to avoid rulemakings that might be challenged in court more easily.
“Relying more on guidances could be good for FDA in the sense that most of regulated industry will just follow guidances anyway,” Holly Fernandez Lynch, assistant professor of medical ethics at the University of Pennsylvania’s Perelman School of Medicine, told Endpoints News. “But it’s bad in the sense that the industry rogues will have more wiggle room and FDA won’t have much leg to stand on for enforcement in those cases.”
She’s also worried about the definition of a drug, which only refers to “disease” and not “condition.”
“Will litigants challenge that and say FDA can’t regulate drugs for normal pregnancy, i.e., medication abortion? I think the saving grace there might be that you’d still need standing to sue and we have seen that at least some courts are willing to push back there (although some aren’t),” Fernandez Lynch said via email.
Courts and companies also may see the SCOTUS change as an opportunity.
Nathan Cortez, professor at Southern Methodist University’s Dedman School of Law, explained how “symbolically, rejecting a major canon like Chevron will clearly embolden not only litigants, but district and circuit court judges who are hostile to regulation.”
But he noted the Supreme Court’s “caution” in Loper Bright, saying the opinion “does not call into question previous rulings upholding agency decisions based on Chevron.”
Stephen Holland, senior counsel in Crowell & Moring’s government affairs group, added via email, “While FDA’s priorities in rulemaking and enforcement vary from administration to administration — and certainly the Biden Administration has taken actions a Republican Administration may not — regulatory processes at FDA tend to remain relatively stable across administrations, at least when compared with other agencies. This is owed in part to the career staff at FDA who focus on science and public health first, as well as sophisticated industry players used to working with the agency on a frequent basis.”
But he also noted that in recent years, judges have overturned FDA interpretations, such as in Genus v. FDA, or in the case of the abortion pill mifepristone, when the FDA’s regulations were effectively set back to 2016. Holland noted that “much of the industry takes the side of FDA. In many instances, the predictability and certainty is paramount for industry.”