Last Wednesday, the Food and Drug Administration announced a change to federal guidelines regarding a drug commonly used to induce abortions — a change that brings the agency guidelines in line with what is now widely viewed as best medical practice. Just one day later, Arizona Gov. Doug Ducey (R) signed legislation requiring abortion providers to follow a previous, outdated protocol. If this new law survives, it would subject many women to additional risk and discomfort without a corresponding medical benefit.
The new FDA guidelines concern a drug known as mifepristone. More than a quarter century ago, a regimen involving relatively high doses of mifepristone was registered in France as a method of inducing abortion during the first seven weeks of pregnancy. The FDA approved the drug’s use in the United States in 2000, using the then-current French regimen.
It is common, however, for medical researchers to continue to study a drug after it has been approved by the FDA and to develop “off label” methods of using the drug that may be safer or more effective than the FDA’s protocol. In this case, doctors learned that much lower doses of mifepristone “have similar efficacy and lower costs compared with those that use mifepristone” at the higher doses described in the older version of the FDA guidelines. Doctors now use medication to induce abortions up to ten weeks into pregnancy, as well, potentially preventing women from having more invasive surgical abortions.
A practice bulletin issued by the American College of Obstetricians and Gynecologists and the Society of Family Planning advises against using the older protocol because the newer method of administering the drug “is as effective” and “results in significantly fewer adverse effects.” These effects include “nausea, vomiting, diarrhea, headache, dizziness, and thermoregulatory effects.” While bleeding is very common after taking mifepristone, in unusual cases a woman can experience severe bleeding that requires emergency medical care.
While the new FDA guidelines explicitly embrace what has been accepted medical practice for some time, the law signed by Gov. Ducey requires abortion providers to continue to prescribe the regimen outlined in the outdated guidelines. This is actually a fairly common restriction pushed by anti-abortion groups in state legislatures. A similar Oklahoma law was briefly before the Supreme Court of the United States, although the justices eventually dismissed that case without deciding it.
Nevertheless, the Arizona law is a particularly virulent form of this fairly common abortion restriction because it contains a provision that locks the law in place even if the FDA updates its guidelines. Though it is unlikely that the Arizona lawmakers behind this law knew that the FDA would change its guidelines one day before Ducey signed the law, they included a provision in the legislation providing that abortion providers must follow the FDA guidelines that existed on December 31, 2015.
It is likely that abortion providers will challenge this law in court, and the fact that the state law purports to overrule the FDA’s judgment could give them a powerful legal argument. It is one thing for the state to instruct doctors to comply with a specific medical regimen approved by federal regulators. It is another thing altogether for state lawmakers to second-guess the federal government’s determination that doctors may administer lower doses of a drug than the state would like them to administer. Even setting aside the constitutionality of the Arizona law, a court may decide that the FDA guidelines preempt the state’s attempt to force doctors to use the outdated regimen.
Additionally, abortion providers will also have a strong argument that the law is unconstitutional. Although a 5–4 abortion decision by the Supreme Court did say that judges should give “state and federal legislatures wide discretion to pass legislation in areas where there is medical and scientific uncertainty,” the FDA’s new guidelines help clear up any remaining uncertainty about whether the outdated regimen should be preferred to the new regimen.