The Food and Drug Law Institute (FDLI) recently held its 2023 Annual Conference on May 17-18 in Washington, D.C. where professionals from the food, drug, medical device, biologics, and tobacco industries gathered to hear important updates and panel discussions from a distinguished group of industry and FDA speakers. The Conference commenced with keynote addresses by Dr. Robert M. Califf, Commissioner of FDA, and Mark J. Raza, Chief Counsel, FDA, followed by interactive panel discussions and breakout sessions on a broad range of relevant and emerging topics, as well as award ceremonies recognizing exceptional members of the food and drug law community.
Of particular importance to all stakeholders in food and drug matters was a panel discussion which highlighted the recent mifepristone ruling and the Supreme Court’s decision to reconsider the “Chevron Doctrine” from its 1984 ruling in Chevron v. Natural Resources Defense Council, both of which could have enormous impact to the FDA in the areas of product approval and agency authority. In short, the Chevron Doctrine provides that, where a statute is ambiguous, courts should defer to the applicable administrative agency’s interpretation, so long as it is reasonable.
The panel addressing this issue was made up of senior members of several highly reputable law firms, senior counsel from industry, and members of the FDLI Board of Directors. While on its face, the mifepristone ruling in Alliance for Hippocratic Medicate v. FDA has been primarily highlighted in the news regarding abortion rights, the U.S. District Court judge, in an unprecedented decision, disregarded the FDA’s scientific expertise and judgment, invalidated a decades-old FDA approval of mifepristone, and undermined the FDA’s agency approval authority. The case is currently stayed by order of the Supreme Court while an appeal is pending in the 5th Circuit U.S. Circuit Court of Appeals, but the outcome has far-reaching implications to the FDA and the industry as a whole.
Upholding the judge’s decision would be an enormous blow to the drug approval process and would establish precedent to afford judges, without necessarily the appropriate scientific or medical background, the opportunity to substitute their own judgment in place of longstanding deference given to the FDA in the area of product approval. This uncertainty would have an immediate and far-reaching impact on the amounts companies are willing to invest in product development and such decisions could affect the supply and availability of drugs and other products. While stakeholders in the food and drug space are hopeful that the decision will be reversed, its attack on the FDA’s authority is troubling and the outcome is hugely important to the industry.
In addition to the mifepristone case, the Supreme Court recently granted a writ of certiorari in Loper Bright Enterprises v. Raimondo to address the issue of whether to overrule or limit the Chevron Doctrine’s applicability. The longstanding “deference” afforded by the Chevron Doctrine to administrative agencies has been largely criticized by certain justices on the Supreme Court and will now be subject to their official review which could result in substantial changes to the landscape of legislative interpretation and the power of administrative agencies, including the FDA. This is another highly important case that we should all be keeping our eyes on.
It was a privilege to attend the FDLI Annual Conference and to hear the various opinions and valuable insights from the panel mentioned above and from all the other speakers and panelists on these important legal matters and other issues affecting our industry. We look forward to attending next year’s Annual Conference to celebrate FDLI’s 75th Anniversary and before that we hope to have the “right” outcome to these cases decided!
