The American Civil Liberties Union is filing a lawsuit against the Food and Drug Administration Tuesday over a rule preventing commercial pharmacies from offering the abortion pill by prescription.
The ACLU argues that the current restrictions on access to medicated abortion violates the 2016 Supreme Court decision Whole Woman’s Health v. Hellerstedt, which emphasized that no “undue burden” can be placed upon women’s access to abortion.
The suit was filed in the US District Court for the District of Hawaii on behalf of a doctor in Kauai, Hawaii, Dr. Graham Chelius, who claimed that in places with no abortion clinics, like his island, this rule often makes it impossible for women to obtain the pill at all.
“Because of the FDA’s restrictions, my patients are forced either to fly to a different provider on another island or to carry a pregnancy to term against their will,” Chelius said in a press release about the lawsuit.
Chelius’s practice does not stock the abortion pill because, he said, some of his colleagues are opposed to abortion and won’t approve the order. Chelius and the ACLU are seeking to overturn the FDA rules, which would then allow him to prescribe the pill and let his patients pick it up from a local pharmacy instead.
Chelius told BuzzFeed News that one of his fellow plaintiffs, the Society of Family Planning, asked the FDA multiple times to amend these restrictions, “But the FDA has refused, and so my patients continue to be harmed,” he said.
Medication is gaining popularity in the US as an abortion method. In 2014, 43% of abortions in the US were medical (using an abortion pill), a statistic that has likely grown, according to Reuters, due to increased access to the pill and education about it.
The FDA, however, has placed some restrictions on the abortion pill (called Mifeprex or mifepristone) by placing it on the Risk Evaluation and Mitigation Strategies list, a category of drug with a “known or potential serious risk,” according to the FDA’s site. The REMS regulations can vary from requiring a medication guide to be included with all prescriptions, to allowing administration of the drug only by a trained professional.
The abortion pill was placed on this list in 2000. The regulations require that the pill can only be given to patients by specially certified medical professionals in hospitals, medical offices, or clinics that approve of the dispensation of the drug. Restrictions on the pill can vary state to state.
The ACLU argues that in areas without clinics that stock the pill, the FDA’s restrictions can make it nearly impossible for women to access it. As is the case in Dr. Chelius’s practice, many hospitals and practices are associated with religious organizations that oppose stocking and administering abortion pills or have other moral objections.
Even if the institution is not opposed to abortion, it is often quite an administrative hurdle for clinics to get the pill approved and stocked, Julia Kaye, an attorney with the ACLU Reproductive Freedom Project, told BuzzFeed News.
“You may have to get sign off from OB-GYN department, and the Pharmacy Committee, and there may be a committee above that,” Kaye said. “So even if there’s no opposition can still be months of administrative work.”
These restrictions, as well as the ever-increasing abortion clinic closures and state laws applying both to medication and surgical abortion that restrict access, can make obtaining an abortion in some areas of the country nearly impossible, the ACLU argued in a release about the lawsuit.
The FDA recently expanded access to medicated abortion. In 2016, the agency extended regulations around Mifeprex to allow patients to obtain it at up to 10 weeks of pregnancy, instead of five, and allowed nurse practitioners and not just doctors to administer it.
However, many doctors and abortion rights activists argue that this is still not enough freedom of prescription, saying that Mifeprex shouldn’t be on the REMS list at all because it is much safer than a number of medications that are not on the list. The American Congress of Obstetricians and Gynecologists (ACOG) argues that the REMS regulation for the abortion pill “is inconsistent with requirements for other drugs with similar or greater risks.”
“A woman who has been prescribed the abortion pill is no safer if the pill is handed to her at a clinic, rather than at a pharmacy, to swallow at home,” Chelius told BuzzFeed News.
Kaye said in the ACLU's press release on the lawsuit that “the FDA’s unique restrictions on medication abortion are not grounded in science — this is just abortion stigma made law.”
The FDA says that, as with other drugs it has approved, it received reports of some “serious adverse events” from women who took Mifeprex, including rare cases of “fatal infections.” However, the FDA added that it is “unknown whether there is a causal relationship between any of these adverse events and the use of Mifeprex.”
Some anti-abortion organizations contend that the abortion pill should be even more regulated than it is now.
“Abortion drugs should not be deregulated and no pharmacy or hospital should have to provide them,” Marjorie Dannenfelser, the president of Susan B. Anthony List, a major anti-abortion political organization, told BuzzFeed News in a statement. Dannenfelser also argued that the “abortion industry” cannot “be trusted to respect the conscience and good medical judgment of pharmacists and other medical professionals,” who may oppose abortion.
Donna Harrison of the Charlotte Lozier Institute, an anti-abortion research organization, dismissed the lawsuit in an email to BuzzFeed News as being “driven by the desire of the abortion industry to not have to physically see patients in the office, but rather to be able to call in prescriptions without seeing the patient.”
ACOG, however, argues that the abortion pill actually increases safety for women, as the mortality rate associated with medication abortion “continues to be lower than the mortality rate associated with childbirth.”
Hal Lawrence, the CEO of ACOG, told BuzzFeed News in a statement that they support the ACLU’s suit, and that many of their their doctors have faced similar hurdles while trying to treat their patients.
“Many ACOG members who do not currently provide medication abortions would write prescriptions for their patients if the REMS did not make it difficult, or even impossible, for them to do so,” he said. “Because there is no medical rationale for the FDA’s restrictions on abortion medications, the REMS serves only to limit women’s access to this important health service. Accordingly, the FDA’s restrictions should be eliminated.”