Mifepristone protocol legislation - the anti-choice movement's disingenuous method of attack on the reproductive rights of women and how courts should respond.

Author:Samuels, Laurah J.
 
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INTRODUCTION

In the past decade, five states have passed laws prohibiting the off-label use of the abortion-inducing drug mifepristone. (1) While these laws are ostensibly passed to protect women from misuse of a dangerous drug, in actuality they represent one of the latest steps in the anti-choice movement's efforts to dismantle the abortion right iterated in Roe v. Wade (2) and controlled by Planned Parenthood of Southeastern Pennsylvania v. Casey? These laws prevent doctors from practicing evidence-based medicine in the manner that they believe best serves their patients, and cost women time and money while potentially exposing them to unnecessary side effects and risks. In addition, these laws force (4) women with pregnancies of forty-nine to sixty-three days of gestation to undergo surgical abortions when medical abortions would be equally appropriate. As with most anti-choice initiatives, the women who are the most affected are those who are most vulnerable. (5) Women without economic or family resources, those in abusive relationships, and teenagers, who often discover their pregnancies later than adult women, are required to undergo unnecessary surgical procedures and spend money and time that they cannot afford because of politically-motivated legislation without a legitimate medical rationale.

Courts examining mifepristone-regulating legislation have come to different conclusions. Two state courts have addressed these laws and determined that they are unconstitutional: Judge Wickham Corwin of North Dakota's East Central Judicial District enjoined North Dakota's law requiring adherence to the Federal Drug Administration (FDA) protocol pending further proceedings, (6) and the Supreme Court of Oklahoma held that Oklahoma's FDA protocol law was unconstitutional under Casey. (7) This issue has also come up in federal court. In a constitutional challenge to Ohio's ban on off-label use of mifepristone, a Sixth Circuit panel affirmed the state's motion for summary judgment on Planned Parenthood's claims that the law was unconstitutionally vague, violated patients' right to bodily integrity, and that it posed an undue burden to women seeking an abortion in the state of Ohio. (8)

On June 27, 2013, the Supreme Court granted certiorari to decide whether Oklahoma's mifepristone protocol legislation violates the constitution under Casey. (9) Due perhaps to re-election concerns in a state with strong anti-choice leanings, (10) the Supreme Court of Oklahoma was very succinct in the opinion being appealed. In affirming the trial court's determination that the law was unconstitutional, the Oklahoma Supreme Court did not fully explain its reasoning, but instead wrote briefly that the "matter is controlled by the United States Supreme Court decision in Planned Parenthood v. Casey" and "this Court is duty bound by the United States and the Oklahoma Constitutions to 'follow the mandate of the United States Supreme Court on matters of federal constitutional law.'" (11) The United States Supreme Court sought clarification from the Oklahoma Supreme Court on the breadth of H.B. No. 1970, Section 1, Chapter 216, O.S.L. 2011, the Oklahoma mifepristone protocol law, before proceeding with the case, (12) and dismissed the writ of certiorari as improvidently granted after the answer was received. (13) Because the Oklahoma opinion is so brief, this Note focuses on the Sixth Circuit and North Dakota opinions in more detail because they fully set forth the constitutional reasoning of courts upholding and striking down mifepristone protocol legislation.

This Note argues that courts should strike down legislation restricting mifepristone use to the FDA protocol because it fails rational basis review, the lowest standard for judging legislation. (14) There is no evidence that the protocol approved by the FDA is any safer for women than the protocol currently being used by abortion providers, and the risks from mifepristone are lower than those of many other medications commonly prescribed offlabel. While it is within a state's police power to regulate the practice of medicine within its borders, it is not permissible for it to use this power to punish a politically unpopular group of people (in this case pregnant women seeking abortions) without a rational justification. (15)

Following this introduction, I will examine the positive and negative ways that courts have reacted to mifepristone protocol legislation and explain why these decisions are important for women's reproductive rights beyond medical abortions. Part I explains the history of mifepristone's approval and use in the United States. Legislation regulating the use of mifepristone is discussed in Part II. Part III outlines the judicial response to mifepristone protocol legislation, while Part IV explains why this type of legislation fails rational basis review. Finally, the significance of this type of legislation and judicial responses is described in the conclusion.

  1. Mifepristone Use in the United States

    Mifepristone is a drug used in combination with misoprostol to induce abortions. (16) It began to be used widely in Europe in the 1980s, and the FDA approved it for use in America in 2000. There was much debate in the United States about mifepristone prior to its approval, and the anti-choice movement fought vociferously to prevent its approval as an abortion agent. (17) Mifepristone is taken in pill form and blocks the hormone progesterone. This breaks down the lining of the uterus. Two to three days after taking mifepristone, misoprostol is taken to expel the fetus. Most women abort within hours of taking the misoprostol, and according to Planned Parenthood's literature, ninety-seven percent of patients abort within days. If there are complications or the fetus is not expelled, a surgical abortion is necessary. (18)

    The FDA has not mandated that abortion providers prescribe mifepristone exactly according to agency specifications. When the FDA approved mifepristone for medical abortions, the agency considered mandating that it be prescribed strictly according to the FDA recommendation, but this requirement was never created. (19) The final labeling includes the language, "medicines are sometimes prescribed for purposes other than those listed in a [medication guide]." (20) The regimen that the FDA approved was 600 mg of mifepristone followed by 400 meg of misoprostol taken orally in a doctor's office. In studies, this regime was shown to be effective up to forty-nine days of gestation. (21)

    Due to politically motivated delays and protests orchestrated by the anti-choice movement, by the time that the FDA approved use of mifepristone, the FDA regimen was no longer considered the state-of-the-art method of using the drug. Since it began prescribing the drug, Planned Parenthood and other providers across the country have used an alternative evidence-based protocol (200 mg of mifepristone followed by 800 meg of misoprostol). (22) This regime is effective up to sixty-three days of gestation and actually has a better success rate at sixty-three days (more than 98%) than the FDA regimen does at forty-nine days (92%). (23) As Planned Parenthood's Reply Brief in the Ohio case summarizes, "every study that has considered the evidence-based regimen followed by the plaintiff clinics concluded that medical abortion is highly safe and effective up to [nine] weeks." (24) In addition to being effective two weeks longer than the FDA regime, the regime preferred by Planned Parenthood and other abortion providers also eliminates extraneous amounts of mifepristone, which can lead to fewer side effects, gives women greater control over the timing and location of their abortion, eliminates a doctor visit, and costs less for women choosing medical abortions and medical abortion providers. (25) The World Health Organization, the American College of Obstetricians and Gynecologists, and the Royal College of Obstetricians and Gynecologists all endorse this method of performing medical abortions. (26) Overall, 96% of medical abortions in the United States are performed using the alternative protocol. (27)

    It is not unusual, necessarily dangerous, or underhanded for abortion providers to use mifepristone off-label. In fact, "[t]he Food and Drug Law Journal estimated in 2003 that off-label uses account for between 25 and 60 percent of all prescriptions in the United States." (28) Once a drug is approved, it is approved for any use, not just those tested by the FDA. (29) Off-label use is important for a number of reasons. These reasons include that offlabel methods often represent the '"best practice' standard of care," that it is not financially possible or useful for the FDA to approve drugs for use in all possible situations, and that physician autonomy is an important aspect of the practice of medicine. (30) In 1994 congressional testimony, physician and former editor of The Journal of the American Medical Association George Lundberg stated: "For a product to have the most effective potential benefits, law and regulation ... must follow, not precede, science." (31) According to one American Medical Association officer: "[I]n some cases, if you didn't use the drug in the off-label way you'd be guilty of malpractice." (32) While using mifepristone according to the FDA label does not necessarily rise to the level of malpractice, it is certainly out of step with the established standard of care across the nation.

    There is no known evidence that the FDA protocol will protect women's health, and it is potentially harmful to women to force them to use it against the best medical judgment of their doctors. First, it requires three times more mifepristone than most doctors believe is necessary. While no one is alleging that this dosage is unsafe, it possibly exposes women to an increased risk of side effects, forces them to ingest an extra amount of a drug that is serving no medical...

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