The Abortion Pill Is Safe and Effective, and We’re Suing to Make it More Accessible

The idea that the regulation of medical care must be based on scientific evidence is not controversial — unless the care in question is abortion.

That is why, today, the ACLU and the ACLU of Hawaii have joined with medical providers dedicated to women’s health to challenge onerous and medically unnecessary restrictions that the Food and Drug Administration imposes on Mifeprex, the abortion pill. Lacking any medical basis, they do not improve women’s health. Rather, by delaying and blocking access to abortion care, they harm women’s health. The restrictions thus violate both the due process protections of the U.S. Constitution and the statutory authority under which the FDA must operate.

Mifeprex is a safe and effective medication that offers a woman the option of undergoing a process identical to an early miscarriage at home. It allows a woman to end a pregnancy on her own terms. Nearly 3 million women in the United States have used the abortion pill to end a pregnancy since the FDA approved it in 2000. But the FDA has prohibited patients from getting this prescription drug in the usual way — with a prescription from a pharmacy.

Again and again, political leaders shamelessly erect unnecessary hurdles to block a woman’s access to safe, effective abortion care. And we’re intent on tearing them down.

Instead, it requires clinicians to register with the manufacturer and then arrange to stock the pills in their facilities. For a variety of reasons — logistical hurdles, fear of anti-abortion violence, or the obstruction of some co-workers who object to stocking the abortion pill — many clinicians simply cannot stock the medication and thus cannot offer it to their patients.

This is a serious obstacle for many women, particularly in rural areas. For instance, Dr. Graham Chelius, one of the plaintiffs, is a family medicine doctor on Kauai who cannot stock the abortion pill in his office — and there are no abortion providers on the island. If not for the FDA’s restrictions, he would write a prescription when a patient comes to him seeking an early abortion. Instead, his patients have to fly to a different island for abortion care, which is expensive and complicated. Often it delays a woman’s abortion by weeks or, in some cases, blocks her from this care altogether.

Yet the restrictions do nothing to improve women’s health. The abortion pill has an excellent safety record, as the FDA itself acknowledged in 2016. According to the agency, the abortion pill “has been increasingly used as its efficacy and safety have become well-established by both research and experience, and serious complications have proven to be extremely rare.” And those rare events are no rarer because of these restrictions: once a woman’s health care provider has prescribed the pill, which the woman may take at home, it makes no medical difference whatsoever whether she is standing in a clinic or in a pharmacy when she receives the pill in her hand.

Lifting the restrictions would eliminate the delays and obstacles a woman faces in obtaining abortion care. Leading medical associations, including the American College of Obstetricians and Gynecologists, support making this safe medication available by prescription at a pharmacy.

If science is not the basis for these restrictions, what is?

FDA scientists are meant to operate free of political interference, but we know that is not always the case when it comes to women’s health. For example, when the FDA refused to allow women to buy Plan B emergency contraception (“the morning after pill,” which prevents pregnancy) over the counter with no age restrictions, a federal judge found that there was “overwhelming evidence of political pressure underlying the agency’s actions.”

It is worth noting that the FDA first imposed the restrictions on the abortion pill in 2000 under President Clinton and then renewed them in 2016 under President Obama — administrations that were at least relatively supportive of abortion rights. It is all too easy for a politician to claim the mantle of reproductive liberty, yet abandon it in practice.