Abortion Case Could Harm Womens’ Health and Upset Pharma Markets

The US Supreme Court is considering a case, U.S. Food and Drug Administration v. Alliance for Hippocratic Medicine, challenging the federal agency’s decisions to expand access to mifepristone, one of two drugs used in medication abortions.

The court’s ruling, expected by June, will have significant implications for both reproductive health and Americans’ access to safe and effective medications. A ruling for the challenges may further the high court’s project of dismantling the administrative state.

The issues in the case trace back to 2000 when the FDA approved Mifeprex (the brand name for mifepristone) to be used in combination with another drug, misoprostol, for abortions.

That approval was subject to certain conditions, including that the drug be dispensed in person by a physician and be followed by two additional appointments (one for dispensing misoprostol), and that prescriptions be limited to pregnancies less than seven weeks in duration.

In 2016, after reviewing overwhelming evidence of mifepristone’s efficacy and safety, the FDA removed the requirement for follow-up appointments, permitted the drug’s use in pregnancies up to 10 weeks in duration, and allowed non-physician clinicians to prescribe it. In 2021, the FDA stated it wouldn’t enforce the requirement for in-person dispensing and would allow mifepristone to be dispensed via mail.

In November 2022, the Alliance for Hippocratic Medicine sued the FDA in the US District Court for the Northern District of Texas, challenging the agency’s approval of mifepristone and subsequent easing of restrictions.

Last April, Judge Matthew Kacsmaryk stayed the FDA’s approval of mifepristone, finding the Alliance had standing to sue. He also found the FDA’s actions were likely arbitrary and capricious in violation of the Administrative Procedure Act and the Comstock Act, a 19th-century law that prohibits distribution via mail of drugs and instruments used to support abortions.

On appeal, a US Court of Appeals for the Fifth Circuit panel found the plaintiffs had standing to sue, but their challenge to the original 2000 approval of mifepristone was time-barred. Nevertheless, the panel affirmed Kacsmaryk’s ruling about relaxing requirements.

This way, the panel claimed the FDA had given inadequate consideration of the cumulative effects of the various modifications and hadn’t sufficiently reviewed the drug’s safety. The court then ordered the FDA to reimpose the original restrictions. Last year, the Supreme Court stayed this order pending its review of the case.

Although the original approval of mifepristone and application of the Comstock Act aren’t now before the Supreme Court, a decision affirming the Fifth Circuit’s ruling will have enormous ramifications for reproductive health. Since its approval, millions of women have used mifepristone safely for abortion care; recent data show that 53% of all facility-based abortions use mifepristone, an increase of 137% from 2012 to 2021—according to the Guttmacher Institute.

Access to telehealth—which the Fifth Circuit’s order would limit—is especially important to patients who don’t live close to abortion services, including those who live in states where abortion remains illegal, and who rely on prescriptions sent by providers in states with abortion shield laws.

Even in states where abortion is legal, access to medication abortion via telehealth allows for easier and less expensive treatment for early gestation termination (≤13 weeks), which accounts for 93.5% of all abortions in the US, based on data from the Centers for Disease Control and Prevention.

In a 2021-2022 Nature Medicine survey on abortion telehealth across 20 states and Washington D.C., 72.3% of all mifepristone-based abortions occurred via telehealth. Beyond abortion, the restrictions that the Fifth Circuit reimposed may also impede care for patients who are prescribed mifepristone “off-label” for the treatment of uterine fibroids, endometriosis, and miscarriage.

Even more broadly, a Supreme Court decision upholding the Fifth Circuit’s opinion may also destabilize the pharmaceutical market. In finding that the plaintiffs had standing to challenge the FDA’s decisions regarding mifepristone, a drug the Alliance’s members neither use nor prescribe, the Fifth Circuit relied on an extraordinarily attenuated chain of unlikely possibilities.

Although the Alliance couldn’t cite a single member who had suffered any type of harm from the drug to date, the panel accepted that a patient who experiences a serious adverse effect from taking mifepristone (an event that occurs in less than 0.32% of patients, based on a 2015 medical study) might seek emergency care at a hospital where a member of the Alliance works.

It also acknowledged that member might be the only available doctor working at that time, and that physician might then be compelled to perform a medical procedure they morally oppose.

If the Supreme Court agrees that such an attenuated chain of unlikely hypotheticals confers standing, almost any health-care provider could weave together a similar chain of hypotheticals to attain standing to challenge any action taken by the FDA.

As a result, the approval of any controversial drug—think vaccines or erectile dysfunction drugs—could be contested. That’s a threat manufacturers would have to keep in mind, potentially reducing investment in beneficial but controversial medications.

Adding to the destabilization, the Fifth Circuit’s opinion showcased a notable lack of deference to FDA decision-making.

For example, the Fifth Circuit demanded the FDA consider studies showing the cumulative effect of the easing of the original restrictions on mifepristone, even though the FDA carefully reviewed numerous studies demonstrating the drug’s safety without the various restrictions. The agency had concluded, based on its expertise, that the type of cumulative study the Fifth Circuit sought wasn’t available nor necessary.

By disregarding the agency’s expert conclusions, based on the plaintiff’s assertions that more and different studies might be useful, the Fifth Circuit opened the door to a judge withdrawing any drug based on their own non-expert opinion that some non-existent study might be helpful.

In 2021, the Supreme Court rejected that approach. Explaining why the courts shouldn’t upset the restrictions on mifepristone that were then in place, Chief Justice John Roberts wrote that “courts owe significant deference to the politically accountable entities with the ‘background, competence, and expertise to assess public health.”

In the three years since, the court’s majority has repeatedly rejected his advice, denying deference to the expert decisions of the Centers for Disease Control and Prevention, the Occupational Safety and Health Administration, and the Environmental Protection Agency.

To date, however, the majority’s efforts to dismantle the regulatory state, and the government’s capacity to protect the public’s health, haven’t touched the FDA. By June we will know if the court’s attack on expertise will extend to the FDA as well.

The case is All. for Hippocratic Med. v. United States Food & Drug Admin., 5th Cir., 23-10362, 8/16/23.

This article does not necessarily reflect the opinion of Bloomberg Industry Group, Inc., the publisher of Bloomberg Law and Bloomberg Tax, or its owners.

Author Information

Wendy E. Parmet is professor of law and faculty director of the center for health policy and law at Northeastern University.

Danika Marzluff contributed to this article.

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