Opinion | A Ban on the Abortion Drug Mifepristone Is Looming

In the most consequential and controversial attack on reproductive rights since the overturning of Roe v. Wade, a Texas judge could ban the safest, most effective, and most common method for abortion in all 50 states. The hyper-conservative anti-abortion group Alliance Defending Freedom (ADF) is seeking to overturn the FDA’s approval of mifepristone (Mifeprex), a medication in a two-pill regimen used to terminate pregnancies through the first 10 weeks gestation. The lawsuit does not target the other medication, misoprostol (Cytotec), which FDA approved to treat stomach ulcers, and can be prescribed off-label for abortion. Misoprostol can induce abortion even without mifepristone, yet the two-pill regimen has become the gold standard.

Given the FDA’s rigorous risk evaluation and mitigation strategy (REMS) for mifepristone and its safe use for 23 years, the case is utterly frivolous and political, but due to “judge shopping” the repercussions for reproductive health and equity are real. Perversely, a single federal trial judge has the power to block a federal law, rule, or action on a national scale. The case could make its way to the Supreme Court, with potentially disastrous consequences for safe, effective abortion access and the authority of the FDA.

ADF claims FDA exceeded its authority in approving mifepristone in 2000. FDA acted under a federal law authorizing the agency to grant “accelerated approval” to drugs “studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit to patients over existing treatments.” ADF claims that mifepristone does not treat an “illness,” and provides no known benefit over surgical abortion. ADF also highlights subsequent FDA decisions to eliminate safeguards to accessing the drug.

The reality is that mifepristone was approved after a politically fraught journey given intense opposition from anti-abortion groups. It took 4 years of FDA deliberations from submission to approval, despite a plethora of completed clinical studies, strong support from medical organizations, and over 10 years of safe use in Europe. When FDA approved mifepristone, it required post-market studies and controlled its distribution, requiring in-person distribution by qualified physicians. In 2008, the Government Accountability Office reported that FDA had acted within its authority in approving mifepristone, supporting FDA’s position that “…the termination of an unwanted pregnancy is a serious condition, and that the drug provided a meaningful therapeutic benefit over existing therapies by allowing patients to avoid the procedure required with surgical termination of pregnancy.”

Abortion medication is now used in over half of all pregnancy terminations. The two-pill regimen (mifepristone and misoprostol) is highly safe and effective, with serious complications requiring hospitalization in just 0.3% of cases (fewer than Tylenol or Viagra), and with ongoing pregnancy in just 1.1% of cases. Compared with surgical abortion, abortion medications promote privacy, dignity, and convenience.

If anything, mifepristone has been treated starkly different than other drugs of the same safety and efficacy profile; FDA’s detailed risk assessments and monitoring under a REMS, along with decades of safe use, make justification for its approval clear.

If FDA’s approval of mifepristone is overturned, the drug would be unmarketable in all 50 states. FDA sets the national uniform standard, so states cannot authorize medication FDA does not approve.

As a result, 65 million women of reproductive age would lose access to the most effective form of existing medication abortion care. While medical termination of pregnancy is possible with only misoprostol, the risk of complications and pain increases, and the efficacy decreases, with studies demonstrating between 80-95% effectiveness. The ruling also impacts miscarriage management, as mifepristone in combination with misoprostol offers the most effective regimen for managing a miscarriage, which occurs in up to a third of pregnancies. Compared with misoprostol alone, taking mifepristone for miscarriage management reduces the likelihood of patients needing an additional procedure, promoting physical and emotional recovery.

Further, a ruling against mifepristone would clash with the Biden administration’s recent strategy to make abortion medication more accessible, including allowing abortion medication to be dispensed by pharmacies and sent through the mail — policies that could significantly increase equity. People who couldn’t take time off work, find child care, or drive long distances to receive the pills in-person from a physician could use telehealth and get the pills from their local pharmacy or delivered to their door. While misoprostol would still be accessible, the discord between the federal branches of government in their treatment of mifepristone has perhaps never been so evident.

As FDA points out in the lawsuit, patients, healthcare providers, pharmaceutical companies, and other businesses rely on the agency’s approval of mifepristone. More broadly, if FDA’s approval of a medication were so easily overturned, especially one so closely studied and clearly proven to be safe and effective, it would dismantle the infrastructure that Americans depend on for medications to treat a whole host of conditions. When Congress gave FDA the authority to regulate drug approval, it recognized that the scientific agency was in the best position to make decisions in the interest of public health.

Beyond abortion, an adverse decision would have potentially disastrous consequences for a whole host of medicines and vaccines. It might open the door to states picking and choosing which FDA-approved products it will, or won’t allow. Another lawsuit recently filed in West Virginia will examine whether the state’s ban on abortion medication is lawful. Imagine a state denying access to an effective cancer or heart disease drug. Or what if states were to authorize products that aren’t FDA-approved? Congress established the FDA to be the nation’s regulator of medical products guided by science. It must have the undisputed power to set a national uniform standard that cannot be politically overturned by a governor, state legislature, or court.

It is unfathomable that a federal judge could side with ADF’s baseless arguments given FDA’s clear and long-recognized authority to approve the medication. Yet, when ADF sued FDA in a federal court in Amarillo, Texas, the group was acting strategically, or “forum shopping” to get the case in front of Matthew Kacsmaryk, a Trump-appointed judge who openly aligns with conservative Christian ideology, perhaps more so than any other judge in the country. (This same judge issued rulings to block the Biden administration’s attempt to end the “Remain in Mexico” policy, prevent workplace guidelines from protecting transgender individuals, and require minors in Texas to get parental approval to access federally-funded birth control).

Judge Kacsmaryk should have dismissed the case from the start given its baseless claim. But since he allowed the action to proceed, regardless of the outcome — expected as early as February 24 — the case is likely to be appealed to the highly conservative 5th Circuit Court of Appeals, and then further appealed to the Supreme Court. With a 6-3 conservative supermajority, our current Supreme Court has shown clear willingness to negate reproductive rights and ignore the consequences to reproductive health. The Court has also consistently ruled to decrease the authority of federal health agencies like the Environmental Protection Agency and the Occupational Safety and Health Administration. The FDA could be the Court’s next target.

As we await the judge’s decision and likely appeals, there has perhaps never been a more critical time for public health advocacy, engaging the wide range of stakeholders including anyone who might ever need, prescribe, or dispense FDA-approved medication. Even the staunchest opponents of abortion should stand up and recognize that this case has gone far too far in jeopardizing America’s access to safe and effective medicines.

Lawrence O. Gostin, JD, LLD, is university professor, Georgetown University’s highest academic rank, where he directs the O’Neill Institute for National & Global Health Law. He is also director of the World Health Organization Collaborating Center on National & Global Health Law, and the author of Global Health Security: A Blueprint for the Future. You can read more of his writing in “The Health Docket” column. Sarah Wetter, JD, MPH, is an associate with the Health and Human Rights Initiative at the O’Neill Institute.