Potential Legal Flaws in State Restrictions Targeting Mifepristone

Having failed in their efforts to ban what they vaguely called "late-term" abortions, anti-choice lawmakers are now poised to attack a drug that makes abortion possible in the earliest days of pregnancy: mifepristone, commonly known as RU-486 or the early-option pill, and sold in the U.S. under the brand name of Mifeprex. As the Bush Administration seeks ways to limit access to mifepristone at the national level, states are also considering statutory restrictions on this early, medical abortion method. Indeed in several state legislatures a variety of bills have already been introduced, and we expect to see more in upcoming sessions. While the principal arguments against these bills are likely to be based on policy, this fact sheet identifies potential legal flaws in the legislation.

There are three broad categories of legislation we anticipate at the state level:

• First, states could attempt to ban mifepristone outright.

• Second, states might place restrictions on the physicians eligible to prescribe the drug. Copying recent federal proposals, such bills might, for example, limit prescriptive authority to physicians who are obstetricians/gynecologists, who have training in surgical abortion, and/or who have admitting privileges at a hospital within a short distance from the offices where they dispense mifepristone. Such unwarranted restrictions could effectively ban mifepristone in those areas -- particularly rural ones -- in which no physician meets these unnecessary requirements.

• Finally, states might pass legislation to ensure that their existing restrictions on abortion apply to mifepristone. Such bills may be redundant, as many state abortion restrictions -- such as parental involvement requirements or mandated waiting periods -- generally apply to all abortion methods, including mifepristone. The application of some restrictions could, however, curtail or even effectively ban the use of mifepristone. Laws requiring pathological examination of fetal tissue after a medical abortion, for example, would be difficult to comply with, as a woman undergoing an early medical abortion is likely to expel the embryo and other products of conception at home. Such a requirement could also effectively ban abortions using methotrexate, a drug that offers the benefit of treating early ectopic pregnancy without surgery on the fallopian tube.

Mifepristone restrictions have numerous potential legal flaws. To the extent that state laws explicitly or effectively prohibit early medical abortion, the Supreme Court has not looked favorably on bans on specific abortion methods. It has considered two method bans and struck them both as unconstitutional -- most recently in 2000, when the Court invalidated a so-called "partial-birth abortion" ban. The Court has recognized two separate grounds on which a method ban violates the constitutional right to abortion: first, it imposes an undue burden on the right to choose abortion; second, it imposes medical harm on some women, particularly when it lacks an exception to preserve a pregnant woman's health.

In addition, the FDA's approval of mifepristone pursuant to federal law may itself preempt the states' authority to pass restrictions on mifepristone. A state ban would conflict with the federal approval of mifepristone and frustrate the federal purpose of giving Americans access to this safe and effective drug. State limitations on which physicians may prescribe mifepristone might also be preempted on the basis that only the FDA has authority to determine that a drug is safe and effective. Once it has done so, a state's determination that additional restrictions are warranted would conflict with the FDA's judgment. Such an impermissible conflict appears all the more likely if a state enacts restrictions that the FDA considered and rejected, as the FDA considered and rejected limiting prescriptive authority to physicians with training to perform surgical abortions. (Instead, the FDA approved prescriptive or supervisory authority for physicians who either have such surgical training or can make appropriate referrals for surgical intervention.)

A state ban or restriction on the distribution of an FDA-approved drug, such as mifepristone, might also unduly interfere with interstate commerce. Because interstate commerce is subject to federal regulation, states cannot unduly interfere with it. State-level bans or further restrictions could frustrate the establishment of a nationally uniform market for safe, effective drugs.

Because of the nature of medical abortion, the application of certain preexisting abortion restrictions could, in violation of the Constitution, lack any rational basis. Purporting to protect health, for instance, several states have imposed unnecessary, burdensome requirements on abortion providers, but not on providers of similar or more risky medical procedures. These targeted regulations of abortion providers -- or TRAP laws -- often include onerous physical plant requirements, such as that the facility include a surgical suite with specific equipment, and a recovery room with a certain number of beds. While the ACLU opposes such laws in general, these laws would be particularly susceptible to challenge as irrational if applied to abortions that entail no surgery, and in which the woman expels the embryo at home.

More generally, any restriction a state might impose on mifepristone may be so lacking in medical, scientific, or moral justification as to be irrational in violation of the Constitution's guarantee of due process. The FDA approved mifepristone following years of extensive and thorough research showing that the drug is safe and effective. For more than a decade, women all over the world have ended early pregnancies safely using mifepristone. There is simply no legitimate reason to deny this medical advance to American women. Laws that lack even a rational basis are unconstitutional.

In the absence of justifications based on true safety concerns, some state legislators have expressed an aversion to the "convenience" of taking a pill. This aversion is not a sufficient basis for legislation. States may not enact laws with the express purpose of making abortion more difficult to obtain or endure. Laws with the purpose of making abortion substantially more difficult to obtain are unconstitutional because they impose an undue burden on the right to choose abortion.