James A. Boiani, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Bloomberg Law Business & Practice, in “FDA Braces for High Court, Final Rule Moves in Election Year,” by Nyah Phengsitthy.
Following is an excerpt:
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. …
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.