Supreme Court Rejects Challenge to FDA Regulation of Abortion Medication

In a unanimous decision today, the Supreme Court rejected efforts to limit access to the abortion pill mifepristone, overturning an earlier decision by the 5th Circuit Court of Appeals. The Supreme Court ruled that the physicians and medical associations who brought the case did not have the right to challenge the FDA's regulation of the drug.

To have standing, plaintiffs must show they have a “personal stake” in the case. They need to prove they have been, or will be, harmed by the defendant and that the court can provide a remedy for this harm. The Court rejected the plaintiff physicians’ claims that the FDA’s relaxed regulation of mifepristone caused them to suffer “downstream conscience injuries” and “downstream economic injuries.” Importantly, the Court highlighted federal conscience laws that protect physicians from being forced to perform abortions or other medical treatments, that violate their consciences. Further, the Emergency Medical Treatment and Labor Act, which requires hospitals with emergency rooms to screen, stabilize and treat or transfer patients, does not apply to individual physicians and does not override conscience protections. In addressing the physician’s claims of economic injury, the Court wrote that the plaintiffs lacked evidence that mifepristone complications have resulted in the diversion of resources from other patients. “Moreover, the law has never permitted doctors to challenge the government’s loosening of general public safety requirements simply because more individuals might then show up at emergency rooms or in doctors’ offices with follow-on injuries.”

The Court rejected the plaintiff medical associations' standing claims, which were based on assertions that the FDA caused them to conduct additional safety studies on mifepristone and its risks. Simply stated, an organization cannot “spend its way into standing. . . by expending money to gather information and advocate against a defendant’s action.”

Finally, the Court rejected the plaintiffs’ “if not us, who?” argument, writing that it was not clear that no one else would have standing to challenge the FDA’s regulation of mifepristone, further noting that some issues may be left to the political and democratic processes.  Given the Court’s narrow decision based on standing, it did not include any discussion of the FDA’s regulatory power to evaluate and approve drugs.

While the decision means that access to mifepristone will remain unchanged, Dinsmore attorneys will continue to monitor the political processes and legal battles affecting abortion-related care. If you have any questions, please contact your Dinsmore attorney.