In a unanimous opinion by Justice Kavanaugh, the Supreme Court ruled today in FDA v. Alliance for Hippocratic Medicine that the doctors and medical association that challenged the FDA’s approval of the abortion drug mifepristone (as well as a series of FDA actions loosening conditions on its use) did not have standing to sue under Article III of the Constitution. Some observations:
1. The Court’s ruling is no surprise. Way back in April 2023, before the Fifth Circuit had even ruled on the merits of the appeal of the district-court decision, the Court issued an extraordinary order (on the “shadow docket”) that blocked the district court’s order from taking effect through the entirety of the litigation. In other words, even if the Fifth Circuit affirmed the district court’s order (as it did in substantial part), the order would not take effect unless and until the Court itself okayed it.
That order strongly indicated that at least seven justices had grave concerns on the threshold question of plaintiffs’ standing. (Justice Thomas dissented from the order without explanation, and Justice Alito dissented on the ground that defendants had “not shown that they are likely to suffer irreparable harm in the interim,” so it is possible that all nine justices then had serious doubts on standing.)
Justice Kavanaugh’s opinion reads like a primer on standing and makes clear that the plaintiffs fell well short of meeting the Court’s test.
2. News reports that assert that today’s ruling “ensures access” to mifepristone (or similar phrasing) are badly misstating things. For starters, state laws against abortion apply to abortions done via the abortion-drug regimen. In addition, some states have laws that specifically target abortion drugs. Although there is some litigation against those laws, the laws should prevail.
Further, federal criminal statutes (often referred to as Comstock Act provisions) broadly bar sending abortion drugs by U.S. mail or common carrier. The Biden administration has embraced an interpretation of those statutes that would eviscerate them. I have explained at length (including in this amicus brief) that the Biden administration’s interpretation is clearly wrong. Whether or not you agree with me, the issue is an open one, and a new administration is free to enforce the Comstock Act.
Today’s ruling doesn’t mention, and has no bearing on, the meaning of the Comstock Act. Indeed, the Biden administration’s position has been that the Comstock Act “is not relevant to FDA’s exercise of its authority under the FDCA [Food, Drug, and Cosmetic Act]”:
The FDCA requires FDA to assess safety and effectiveness when it approves a drug and sets the conditions for its use. Nothing in the statute requires FDA to address in those decisions other laws that may restrict the drug’s distribution or use. Instead, the FDCA properly leaves enforcement of those laws to the agencies charged with their administration. For example, the Controlled Substances Act restricts distribution of fentanyl, but FDA has not incorporated those restrictions into its approval or REMS for certain fentanyl products. [Brief at 56-57 (emphasis added).]
(It separately argued that the district court misinterpreted the Comstock Act.)
In other words, the Biden administration’s position is that FDA approval is just one of several permission slips necessary for the lawful distribution and use of mifepristone. Today’s ruling means that mifepristone continues to have the FDA’s permission slip. But it does not mean that it has the state-law permission slips or the Comstock Act permission slip.
As I have pointed out before, violation of the Comstock Act is subject to steep penalties: a prison sentence of up to five years for a first offense and up to ten years for each additional offense. Further, because violations of the Comstock Act count as predicate instances of “racketeering activity” under the federal Racketeer Influenced and Corrupt Organizations Act (RICO), they subject a violator to RICO’s severe criminal penalties, which include for each violation imprisonment for up to twenty years, a fine of $250,000, and forfeiture of any property interest in the criminal enterprise (e.g., ownership interest, including stock options, in a company involved in the racketeering). Plus, the five-year statute of limitations means that a continuing violator will never be safe from prosecution.
No competent attorney would advise a client that there is no risk of being prosecuted for sending or receiving abortion drugs and of incurring a sentence of a lifetime in prison and massive financial penalties for doing so. And that, of course, is on top of state laws that criminalize distribution of abortion pills.
3. The Court’s ruling on standing rests on a robust view of the conscience protections that federal law currently affords doctors:
[D]octors would have standing to challenge a government action that likely would cause them to provide medical treatment against their consciences.
But in this case … the plaintiff doctors have not shown that they could be forced to participate in an abortion or provide abortion-related medical treatment over their conscience objections.
That is because, as the Government explains, federal conscience laws definitively protect doctors from being required to perform abortions or to provide other treatment that violates their consciences.
Moreover, as the Government notes, federal conscience protections encompass “the doctor’s beliefs rather than particular procedures,” meaning that doctors cannot be required to treat mifepristone complications in any way that would violate the doctors’ consciences. As the Government points out, that strong protection for conscience remains true even in a so-called healthcare desert, where other doctors are not readily available.