It’s scary that abortion opponents are trying to revoke FDA approval of a drug
In the post-roe world, one of the prime targets of antiabortion activists is medication abortion, a twodrug regimen in which a pregnant person takes mifepristone followed by misoprostol. A lawsuit filed late last year by abortion opponents in an Amarillo, Texas, federal district court asks Judge Matthew Kacsmaryk, a conservative known for his anti-abortion views, to revoke the U.S. Food and Drug Administration’s approval of mifepristone. They argue the agency didn’t properly study the drug and has removed “even the most basic precautionary requirements” associated with its use. Kacsmaryk is expected to issue a ruling any day now.
The claim is weak given that medication abortion has been available in the U.S. since 2000, is currently used for more than half the abortions in this country and is exceptionally effective and safe (with serious adverse effects occurring in less than a third of 1% of the abortions). If anything, health care providers and researchers believe it has been overly regulated. For years, obtaining a prescription for abortion medication required at least one in-person visit and was available only in certain health care settings and under certain conditions. Recently the FDA expanded the rules to allow telehealth visits to get a prescription and allowed the drugs to be dispensed through pharmacies that meet certain qualifications. (However, on Friday, Walgreens, one of the nation’s largest retail pharmacies, bowed to pressure and announced it would stop providing mifepristone in 20 states where attorneys general are challenging the legality of its use.
Lawyers for the Department of Justice and the FDA contend that the department comprehensively evaluated mifepristone before approving it for medication abortion. In court documents, they say the agency “reviewed three separate clinical trials involving more than 2,500 pregnant patients, and those trials provided substantial evidence of effectiveness and showed a low rate of serious adverse events.” The FDA also defended the drug as offering “a meaningful therapeutic benefit to some patients over surgical abortion” because it avoids an invasive (although very safe) surgical procedure for abortion.
If the judge revokes the FDA’S authorization of mifepristone, lawyers believe that would be unprecedented. “We are not aware of any case in which a court has removed a drug from the market over FDA’S objection,” a group of food and drug law scholars wrote in an amicus brief for the FDA.
It would also be another medically baseless attempt by abortion opponents to deny health care access to pregnant people. Nearly half the states in the country have abortion bans or such tight restrictions that they severely limit access. Now anti-abortion activists are trying to slap restrictions on abortion access in states where it is allowed and protected.
Thankfully, pulling mifepristone, which is used mainly for abortions and miscarriage care, off the market won’t stop medication abortions, though it could sow confusion and disruption across the nation. The second drug, misoprostol, can be used alone for abortions, though it is slightly less effective. It is not subject to the same restrictions because it has other clinical uses, such as treating gastric ulcers.
The two-drug regimen works up to 99% of the time while the misoprostol-only regimen works up to 97% of the time, according to Lauren Kokum, director of affiliate communications for Planned Parenthood Federation of America. The organization allows its 49 affiliates that run 600 health care centers in the U.S. to use misoprostol alone.
Meanwhile, state legislatures continue to pile more restrictions on abortions. Iowa lawmakers introduced a bill recently that not only would ban abortion but also would add the ludicrous requirement that internet providers block people’s access to websites related to abortion care while they are in the state.
The extreme lengths to which antiabortion activists will go should trouble everyone who cares about the exercise of civil rights, particularly the right to control your own body. These assaults on abortion access will continue either until every state has a constitutional amendment guaranteeing a right to abortion or until Congress passes a national law allowing abortion in every state. Think about that the next time you vote for a member of Congress.