Manatt Health Partner Rachel Sher was quoted in Law360 on how the mifepristone litigation could impact the Food and Drug Administration’s (FDA) drug approval and regulatory authority. On March 26, 2024, the Supreme Court held oral arguments in Alliance for Hippocratic Medicine (AHM) v. U.S. Food and Drug Administration, et al. (AHM v. FDA), which Sher recently reviewed here along with Manatt Health Partners Julian Polaris and Randi Seigel and Associate Matthew Itzkowitz.
As Sher and Polaris have previously discussed (here and here), anti-abortion physician organizations led by AHM sued FDA in 2022, challenging FDA’s original approval of mifepristone from 2000, and subsequent regulatory changes relating to restrictions of the drug and approval of a generic version. As noted in the Law360 article, the oral arguments focused heavily on whether the anti-abortion physicians have “standing” to sue the FDA for these actions. A majority of the justices expressed skepticism that the legal standard had been met in this case.
As Sher noted in the article, “If the court ultimately concludes that the 'chain of remote possibilities' relied upon by the doctors here could provide a basis of standing—these individuals have never prescribed mifepristone and have no intention of ever doing so—then it is hard to see what guardrails would remain to prevent anyone from suing to reverse FDA approval of any drug.”
According to Sher in a previous Law360 article, the analyses from the lower courts could lead to more challenges to FDA drug approvals and could invite "essentially anyone" to challenge an FDA drug approval.
Subscribers can read the full Law360 article here.