The Justice Department, which is representing the F.D.A., immediately said it would appeal the Texas injunction to the Fifth Circuit Court of Appeals.
In response to the Texas ruling, the F.D.A. said its “approval was based on the best available science and done in accordance with the laws that govern our work.”
The agency added, “F.D.A. stands behind its determination that mifepristone is safe and effective under its approved conditions of use for medical termination of early pregnancy, and believes patients should have access to F.D.A.-approved medications.”
R. Alta Charo, a professor emerita of law and bioethics at the University of Wisconsin and an author of a brief by drug-policy scholars in support of the F.D.A., said, “The biggest threat that a decision like this brings is the threat of creating chaos.” The ruling, she added, could empower a range of groups to begin “looking over the shoulder of the F.D.A., re-evaluating their risk-benefit analyses.”
The agency has faced a series of reputational broadsides in recent years. Under President Donald J. Trump, the F.D.A. was maligned for bowing to political pressure to authorize Covid treatments that turned out not to be helpful. It faced searing criticism over its approval of Aduhelm, a controversial Alzheimer’s drug with uncertain benefits and significant safety risks. And it continues to face the wrath of the public and lawmakers who question several opioid drug approvals granted amid rising overdose deaths.
Some experts in reproductive health law and drug policy say that, while the Supreme Court decision overturning Roe v. Wade allowed each state to decide whether to ban or permit abortion, it did not allow states to take actions to bar the medications used in abortion, because those are regulated by the F.D.A. States are allowed to adopt some laws and regulations that supplement federal rules on drugs and to regulate the practice of medicine within their jurisdiction. But states cannot impose policies that interfere with or contradict F.D.A. standards or requirements, so they cannot ban or drastically restrict a medication the federal government has approved, these experts say.
More on the U.S. Supreme Court
- Uncomfortable Revelations: Democratic lawmakers reiterated calls to tighten ethics rules for the Supreme Court after ProPublica reported that Justice Clarence Thomas had accepted luxury gifts and travel from a major conservative donor without disclosing them.
- Trans Athletes: The Supreme Court issued a temporary order allowing a transgender girl to compete on the girls’ track team at a West Virginia middle school.
- A Constitutional Test: Two criminal defendants have asked the Supreme Court to decide whether testimony given remotely against them during the pandemic violated the Sixth Amendment’s confrontation clause.
This year, two federal lawsuits have been filed against state bans or restrictions on medication abortion, claiming that the F.D.A.’s authority cannot be second-guessed by states. The lawsuits — one filed by a mifepristone manufacturer, GenBioPro, challenging West Virginia’s abortion ban and the other filed by an obstetrician-gynecologist challenging the additional restrictions North Carolina applies to medication abortion — assert that the actions of these two states are unconstitutional.
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