FDA Prepares for High Court, Final Rule Moves in Election Year

The nation’s food and drug regulator is set to move forward in 2024 on long-awaited rules and guidances, spurred on by an election year that comes amid a legal battle at the US Supreme Court over the agency’s actions.

The Food and Drug Administration’s plans to regulate lab-developed tests, ban certain tobacco products, clarify guidelines for medical devices and artificial intelligence, and act on drug shortages are among the many tasks stakeholders are following from the agency into the new year.

That work comes with the Supreme Court set to hear an appeal from the FDA regarding a Fifth Circuit ruling on the agency’s supervision of the abortion pill mifepristone, which could end mail access to the drug and introduce other underlying restrictions.

FDA attorneys closely watching the administration’s moves say scrutiny from the nation’s high court, along with the upcoming election, is likely to result in a flurry of activities from the agency—prompting action in the early new year all the way into late September.

“We could see a really busy year because the agency is going to want to clear as many priorities as they can. It will want to clear off its plate before it gets into a window of time where new administration could come in and reconsider policies that have been put in place,” said Stacy Cline Amin, a partner at Morrison Foerster and the FDA’s former chief counsel.

The FDA’s moves at end of 2023 also show the agency acting swiftly, according to Josh Oyster, an FDA attorney at Ropes & Gray, in regards to recent movement on rules and guidances.

The agency “appears very poised to do a lot more in the early part of next year or as much as they can going into the election,” Oyster said.

Priorities Ahead

Among the many tasks attorneys are eyeing from the agency is the proposal to regulate lab-developed tests as medical devices under the Federal Food, Drug, and Cosmetic Act. Lab-developed tests can detect Covid-19, blood infections, breast cancer, and other diseases or conditions.

Attorneys say the regulation could spark substantial litigation—some of the biggest the agency has seen in years—as critics argue the agency doesn’t have the authority to regulate LDTs.

The regulatory agenda currently schedules the FDA to finalize the rule in April 2024, but stakeholders worry the agency won’t have enough time to review the thousands of comments it received on the proposal.

It’s also possible “Congress is rejuvenated” in the new year to discuss legislation relating to LDT reform, Oyster said.

The Verifying Accurate, Leading-Edge IVCT Development (VALID) Act would have clarified the FDA’s authority over LDTs, but Congress failed to advance those provisions.

Two final rules pushed into spring 2024 that could also result in major litigation—which have received both praise and pushback—are the bans on menthol cigarettes and flavored cigars.

Hospitals, health centers, and patients have also urged both Congress and the agency to develop plans to address the drug supply chain following an increase in shortages.

FDA attorneys are also closely watching rules and guidances related to the agency’s moves on clinical trial diversity, artificial intelligence, cosmetic product reform, medical device shortages, and prescription drug advertisements.

Other agency priorities were laid out in the fall regulatory agenda for next year, with the FDA expected to finalize rules ranging from food labeling to prohibition of tobacco sales for minors.

The FDA earlier this year also laid out goals in the Center for Devices and Radiological Health proposed guidances, the Center for Tobacco Products’ five-year strategic plan, and the fiscal year 2024 budget. The agency’s implementation of the unified Human Foods Program and new model for the Office of Regulatory Affairs are also possible for 2024.

Challenges at the Supreme Court

The FDA’s case now in line for review at the Supreme Court will be a “unique” one to watch, said James Boiani, FDA attorney at Epstein Becker Green, given that this review will test the power of federal judges that overruled the FDA’s supervision of abortion pill mifepristone.

“A lot of the underpinnings are really fundamentally about how FDA approves drugs. That that could create a lot of uncertainty depending on how it goes at the Supreme Court,” Boiani said.

The cases Food and Drug Administration v. Alliance for Hippocratic Medicine and Danco Laboratories v. Alliance for Hippocratic Medicine are expected to receive a decision from the high court in the middle of 2024.

The FDA, along with other federal agencies, is also waiting for the Supreme Court’s take on Loper Bright Enterprises v. Raimondo, a case where justices will weigh whether to continue giving agencies “Chevron deference” for interpretations of ambiguous terms in their statutes.

The court’s decision will have major impact on every regulatory agency, but the outcome for the FDA will be interesting given that the agency’s staff is filled with scientists and technical experts, Cline said.

“Having in place Chevron deference lets FDA sort of weigh the policy arguments in favor of one approach or another. It provides stability to the industry to have one national standard that’s applied,” Cline said.

“But could we end up in a situation where we’ve got different interpretations coming out of different circuits on the statute that really needs to be applied uniformly for it to make any sense? It leaves a lot of questions for the industry,” Cline said.