San Francisco — Sixteen years ago next month, the Food and Drug Administration approved the first “abortion pill,” and today medication abortion accounts for about a quarter of all nonhospital abortions in the United States. Not only is it safe and effective, but for women who live in the 89 percent of American counties that lack even a single abortion provider, it is often the only feasible option.
Not surprisingly, state legislatures bent on eliminating abortion access have targeted medication abortion, passing several new laws with the stated intention of safeguarding women’s health and safety. But in a research paper I co-wrote on Tuesday in the online journal PLOS Medicine, my colleagues and I found that such laws are not just covers for restricting abortion access — they can actually harm women’s health.
These laws include limitations on the types of health care providers who can give women the pills, prohibitions on prescribing the pill remotely (through telemedicine) and bans on home self-administration. And we can expect even more such laws aimed at medication abortion, now that the Supreme Court has effectively blocked states from using women’s health as a basis for restricting access to abortion clinics.
In Ohio, which was the focus of our research, a 2011 law required abortion providers to use an F.D.A.-approved two-drug regimen (mifepristone and misoprostol); under the law, women must make two visits to a doctor’s office to take both the drugs. On its face, laws like Ohio’s seem sensible enough — why shouldn’t doctors follow federal guidelines? Because those guidelines can be severely out of date.
F.D.A. guidelines take a snapshot in time. Clinical research is continuing. Best practices are constantly improving. The F.D.A. can’t keep up, and when a drug maker wants the agency to update its guidelines, it must submit a complex and costly application. Fortunately, there’s a legal shortcut: Physicians can and often do prescribe medications off-label — i.e., for uses or in regimens different from what the F.D.A. recommends. A 2006 study estimates that 21 percent of all prescriptions are for off-label use.
Not only is the law misguided; it also led to worse outcomes for women’s health. We examined medical charts from almost 3,000 patients at four Ohio clinics getting medication abortions before and after the law. After the law, the percentage of patients requiring additional medical treatment rose from 5 percent to 14 percent — including, in some cases, an in-clinic procedure to complete the abortion, which is what many women were trying to avoid by opting for a medication abortion in the first place.
The four clinics we studied saw an 80 percent decline in medication abortions between 2010 and 2014, compared with a 17 percent decline in all abortions over the same time period. Medication abortions declined from 22 percent of all abortions in these clinics in 2010, before the law, to 5 percent after the law in 2014.
There is some good news at the federal level: The F.D.A. label for medication abortion was updated in March 2016 to match the latest guidelines, so providers in Ohio — as well as in North Dakota and Texas, which have similar laws — may now legally treat women with the current evidence-based regimens.
But as long as laws like Ohio’s remain in place, this is a short-term victory — the 2016 F.D.A. regimen will most likely become outdated in the future. In fact, clinical trials are currently underway to test the safety of pharmacy access of medication abortion pills and extending use from 10 weeks to 11 weeks of pregnancy. If these trials prove successful, women in Ohio, North Dakota and Texas will not be legally allowed to get the most up-to-date care.
Claims that abortion laws will protect women’s health and safety are just that — claims. We need scientific research that evaluates these laws’ actual effects on women and their health. If state legislatures want to create policies around abortion, they should be based on evidence. When policy is not based on science, American women pay the price.