BY ALICE PARK
GOOD QUESTION
THE ABORTION PILL MIFEPRISTONE HAS been on uncertain legal ground since a Texas judge ruled on April 7 that the U.S. Food and Drug Administration (FDA)’s approval more than two decades ago should be suspended. After the Department of Justice appealed the decision and requested that the Supreme Court step in, the high court decided that mifepristone should remain available while courts continue to decide its legal fate.
With one abortion pill in legal limbo, experts are now worried about possible threats to the other one: misoprostol. The drug is FDA approved to treat ulcers and, when used with mifepristone, to induce abortion in a person’s first trimester of pregnancy. Taking the pills together is more effective and linked to fewer side effects than using misoprostol alone. In many parts of the world, however, doctors use misoprostol on its own for abortions. Health care providers in the U.S. can still use just misoprostol for abortions or to manage miscarriages in what’s called off-label use, a common practice that allows them to prescribe any approved drug for purposes other than those for which they are indicated.
If mifepristone loses its status as an approved drug, or if its use is restricted, misoprostol could become the only option for medication abortion—and the next abortion battlefield.
THE UNPRECEDENTED LEGAL CHALLENGE to one abortion pill shows how the other might be vulnerable. While misoprostol’s approval as an ulcer drug is unlikely to come under legal threat, its use in abortion might. If that happens, aggressive prosecutors could charge people who travel to other states to take the pill, or even their prescribers.
Just as plaintiffs brought a case against the FDA questioning the approval of mifepristone, parties could challenge the FDA’s regulation of off-label use—not only for misoprostol, but for any drug. “If the challenge to mifepristone is successful, it could open the floodgates to litigation against other drugs,” says Lawrence Gostin, director of the World Health Organization Collaborating Center on National and Global Health Law at Georgetown Law.
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