In 2004, the Ohio legislature passed a law barring use of RU-486, the combination drug used for early termination of pregnancy, unless it was prescribed strictly in accordance with official labeling by the Food and Drug Administration. The law never went into effect because of an injunction immediately sought and won by Planned Parenthood of Ohio and partner organizations in a suit claiming the law was unconstitutionally vague, lacked an exception to protect patients' lives and health, and created undue burdens on a woman's right to access abortion care by limiting their options and forcing many to undergo surgical abortion rather than early medication abortion.
After remaining under injunction as it wended its way through court for the past seven years, the case came before Ohio Federal District Court Judge Susan Dlott, who vacated the injunction and set the stage for enforcement of the law.
Both the law and the court's decision ignore the medical and scientific evidence regarding safety of RU-486 and create a different standard for clinical delivery of an abortion drug than for other drugs approved by the FDA. As a result, fewer women in the state seeking to end an unwanted and untenable pregnancy will be able to access RU-486 for early termination and will instead be forced to undergo surgical abortion instead. Moreover, those whose doctors can and do prescribe RU-486 will have to pay more, in some cases three times as much, for the drug: "Strict adherence" to the FDA labeling standards ironically requires administration of much higher doses of mifepristone than data collected since the original FDA approval show to be necessary and effective for inducing abortion.
RU-486, or mifepristone, was approved for use in the United States by the FDA in September 2000. The drug blocks the action of the hormone progesterone, which is needed to sustain a pregnancy. Mifepristone has been used, in combination with other medications called prostaglandins, for medical abortion since 1988 in France and China, and since the early 1990's in the United Kingdom and Sweden. It has been licensed for use in 37 countries, including the United States.
The FDA approval of mifepristone in the United States was based on data derived from clinical trials involving less than 3000 women in the mid-nineties, all of which followed a certain regimen. The data from these trials were submitted for review to the FDA, and the regimen used in the trials was the one specifically approved by the FDA for use in medication abortion up to 49 days of pregnancy.
Since the original trials were conducted, however, data on more than 1.5 million women in the United States alone and millions of women around the world have been collected. These data who that mifepristone administered in lower doses and in combination with the drug misoprostol can safely and effectively terminate a pregnancy up to 63 days. The combination--again using lower doses of mifepristone--is more than 90 percent effective in terminating a pregnancy. Moreover, data show that the off-label regimens have fewer side effects and allow a woman to take part of the combination of drugs at home, thereby lowering both clinical as well as personal economic costs (money, time, travel and the like).
Not happy with expanding access to early medication abortion, in no large part because it reduces the ability to harass and stigmatize women for terminating a pregnancy, anti-choice advocates have repeatedly attacked medication abortion in much the same way they have surgical abortion: spreading lies and distortion about the medical safety of abortion procedures, stigmatizing abortion (and contraception) and seeking to pass one law after another of spurious barriers to access to abortion, all under the guise of "protecting women."
The 2004 Ohio law is one such example: By forbidding off-label use of mifepristone, means doctors can not practice evidence-based prescribing, or in other words, can not use their medical judgment to prescribe an already-approved drug in accordance with the most recent medical and clinical data available.
Administration of Mifepristone Under Evidence-based Practices Not Allowed Under Ohio Law
Clinical studies have shown that several variations in mifepristone/misoprostol treatment regimens are safe and effective. Generally, however, once a woman has decided to have a medical abortion, there are three steps in the process of a medical abortion:
Step One (at the medical office or clinic)
- A medical history is taken and a clinical exam and lab tests are performed.
- Counseling is completed and informed consent is obtained.
- If eligible for medical abortion, the woman swallows the mifepristone pill(s).
Step Two (at the office/clinic or at home depending on the treatment regimen)
- This step takes place within about 2 days of step one.
- Unless abortion has occurred and has been confirmed by the clinician, the woman uses misoprostol. Misoprostol tablets may be swallowed, placed between cheek and gum, or inserted into the vagina, depending on the treatment regimen.
Step Three (at the office or clinic)
- This step takes place within about 2 weeks of step two.
- The clinician evaluates the woman to confirm a complete abortion. It is essential for women to return to the office/clinic to confirm that the abortion is complete.
- If there is an ongoing pregnancy, a suction abortion should be provided.
- If there is an incomplete abortion, the clinician will discuss possible treatment options with the woman. These may include waiting and re-evaluating for complete abortion in a number of days or performing a suction procedure.
Among other points, the Planned Parenthood case argued that the law posed an undue burden on women's right to access safe abortion, in part because Ohio now requires 4 trips to a clinic for medication abortion instead of the two above, and therefore, according to Planned Parenthood the act "violates a woman's right to bodily integrity because it compels surgical abortion in circumstances where medical abortion would otherwise be desired or appropriate treatment."
The suit also argued that the law was unconstitutionally vague because it required physicians to comply with FDA labeling, despite confusion on just what interpretation of the labeling applied.
Planned Parenthood attributed the law's vagueness to "language requiring physicians to comply with 'all provisions of the federal law' [that] did not make clear what specific standards physicians must follow in order to prescribe or administer mifepristone without risking prosecution."
The abortion providers maintained that the law requires doctors to follow the FDA's printed labeling for the drug, though that labeling is contradictory and consists of four separate documents.
In this regard, and others, mifepristone is being treated differently under Ohio law than many other commonly-used drugs which are prescribed off-label using evidence-based criteria. It has been estimated, for example, that up to one-fifth of drug prescriptions in the United States are off-label; this percentage rises to approximately one-third among psychiatric drug prescriptions and to nearly one-half among cardiac medication prescriptions. A 2009 study found that 62 percent of pediatric office visits included off-label prescription practices. A 1997 study of cancer doctors by the American Enterprise Institute and the American Cancer Society found that 60 percent of the doctors prescribed drugs off-label, and a 1991 study by the United States General Accounting Office found that more than half of cancer patients were prescribed at least one drug off-label.
Certain types of birth control pills are prescribed to treat endometriosis although the FDA has only approved them as contraceptives. Avastin, a drug approved to treat certain types of cancer, is used to treat late-stage, age-related macular degeneration. Doxepin, an antidepressant and insomnia medication, is recommended off-label to treat severe allergies. In fact, most common drugs administered to children are in fact off-label use as they have been tested in adults.
And some anti-depressants, such as Prozac, Zoloft, and Paxil, are recommended for the treatment of premature ejaculation.
These are but a few examples of the evidence-based prescribing in which doctors engage every day to most effectively treat their patients.
Under Ohio law, however, mifepristone is singled out and its use off-label prohibited. This despite the fact that the on-label dosage is higher, requiring 3 doses, instead of one. At $90.00 a pill, the cost of the drug for early medication abortion triples to $270.00, a clear barrier for many poor women seeking to terminate an untenable pregnancy. The law also results in more visits to the doctor, less autonomy on the part of the woman, and, because the off-label cut-off of 63 days is now against Ohio law, an increased number of surgical abortions. While first trimester surgical abortions are among the safest medical procedures carried out in the United States, medication abortion carries even fewer risks and is less expensive overall. From a medical and ethical standpoint, the law is forcing women to spend more money to undergo a relatively riskier procedure, all against the prevailing evidence.
Still, Judge Susan Dlott handed a victory in the form of a summary judgment to the Ohio Attorney General and to the anti-choice movement, without hearing any evidence in the case. In regard to the issue of vagueness, Dlott wrote that "[t]he Court is confident that physicians have fair notice of what conduct is prohibited," she wrote.
Dlott also denied Planned Parenthood's claim that restricting action to medication abortion is an infringement on women's rights to access, stating "the Act does not force women to undergo any procedure, surgical or otherwise."
"When broken down, Plaintiffs' argument appears to be this: by prohibiting off-label use of mifepristone, the Act leaves women with gestational durations exceeding 49-days with no other option but a surgical abortion to terminate their pregnancies," according to the 30-page ruling. "While this may be true, it does not change the fact that the Act itself does not compel women to undergo surgery to terminate a pregnancy."
According to Courthouse News, Dlott declined, however, to dismiss the claim that says the law is unconstitutional because it lacks an exception to protect the health or life of the mother.
"Defendants argue that medical disagreement exists over the need for a health or life exception, and yet Defendants also concede that surgical abortions pose greater risks for women with medical complications," Dlott wrote. "These contentions are, at a minimum, laden with contested factual issues that cannot be resolved in Defendants' favor on summary judgment." "The current record indicates, and Defendants concede, that surgical abortions pose greater risks for women with medical complications," she added. "Additionally, both parties are able to articulate the discrete instances in which an off-label mifepristone abortion may be medically necessary."
"We are very disappointed in the federal district court ruling," said Planned Parenthood Ohio in a statement the day of the ruling. "[It] denies women in Ohio access to the same safe abortion care that is available in every other state in the country. We continue to believe that this law which prohibits Ohio women from having full access to medication abortion violates their constitutional rights."
This ruling upholds a bad law passed by Ohio politicians who think they know better than doctors how to practice medicine. Evidence-based prescribing is common practice in all aspects of medicine, but the judgment of Ohio doctors is being trumped by right-wing, ideological legislators when it comes to this one, safe medication.
Planned Parenthood and other advocates are considering their next steps.