Lawyers for Mifepristone Speak after Supreme Court Arguments

Hi there. I’m Jessica Ellsworth from Hogan Lovells. We appreciated the opportunity to present our case to the Supreme Court, and we thank the justices for their thoughtful and thorough questions. The issues in this case are not hard under existing precedent. The same rules should govern here that govern any challenge to any agency decision by any plaintiff.

(00:26)
First, the respondents have not been harmed by the FDA’s decisions about the use conditions for mifepristone. They fail to show, under any rational legal standard, why they have standing to bring this suit. The fact is they don’t.

(00:43)
Second, Congress entrusted the FDA with the sole authority to approve new drugs and subsequent changes. The federal judiciary has respected that authority for decades, applying an appropriately narrow standard of review to FDA’s drug approval decisions. In approving Mifeprex nearly a quarter of a century ago and in its subsequent changes to how the use is prescribed and used, the FDA acted on an extensive body of evidence and well within its authority and in accordance with the law. Second guessing the scientific data-driven judgments of an independent agency is an extreme position that could inject uncertainty across American life.

(01:35)
Under the respondent’s theory, the medicines Americans rely on to manage and cure any number of conditions and diseases could be in jeopardy years after FDA’s approval, and the ability of the American pharmaceutical industry to develop and get approval for new drugs would be severely harmed, slamming the door on promising research into medicines for everything from Alzheimer’s to cancer. Fortunately, there is no basis in law, or precedent, to find for the respondents, and we have urged the court today to overturn the Fifth Circuit’s decision.

(02:15)
We thank the court for its time and attention in this matter, and we look forward to its resolution of the case. Thank you.