Monday, September 11, 2023
The Department of Justice petitioned the U.S. Supreme Court to intervene in the Fifth Circuit's decision in U.S. Food and Drug Administration v. Alliance for Hippocratic Medicine. Here are key excerpts:
The Fifth Circuit’s decision warrants this Court’s review because it would impose an unprecedented and profoundly disruptive result: Neither respondents nor the courts below identified any prior decision abrogating FDA’s approval of a drug or limiting a drug’s availability based on a disagreement with the agency’s judgment about safety or effectiveness much less doing so at the behest of plaintiffs with such an attenuated claim of standing and imminent harm.
In taking that step here, the Fifth Circuit countermanded a scientific judgment FDA has maintained across multiple administrations; imposed unnecessary restrictions on the distribution of a drug that has been safely used by millions of Americans over more than two decades; and upset reliance interests in a healthcare system that depends on the availability of mifepristone as an alternative to surgical abortion for women who choose to lawfully terminate their early pregnancies. At earlier stages of this case, hundreds of amici filed briefs underscoring the harmful consequences of the lowercourts’ decisions.Beyond those destabilizing practical consequences, the Fifth Circuit’s decision also warrants this Court’s review because of its serious legal errors.