By The Herald Editorial Board
The cold comfort that was offered to abortion rights supporters following the U.S. Supreme Court’s Dobbs decision, which overturned the nearly 50-year status quo of Roe v. Wade, was that the legality of abortion was now a question for the states to decide; that states such as Washington — whose voters had legalized abortion in the first trimester of pregnancy in 1970, three years before the Roe ruling — could keep their laws on the books and protect that reproductive right.
Less than a year after the Dobbs decision, however, a lawsuit in Texas — engineered to land before a Trump-appointed federal court judge with a history of long-standing affiliations with the religious right — could force the U.S. Food and Drug Administration to pull a medication from its approval that has been used safely and effectively for 20 years to end pregnancies in their first 10 weeks.
In all 50 states.
The lawsuit against the FDA seeks to overturn the agency’s approval of the drug mifepristone, which is used in tandem with a second FDA-approved drug, misoprostol. Mifepristone blocks progesterone, a hormone necessary for pregnancy, while misoprostol causes the uterus to contract and expel the embryo.
Medication abortions, such as that when the combination of mifepristone and misoprostol are used instead of a surgical procedure, is currently the most common treatment to end pregnancies, especially in the first trimester and particularly for those who live in regions where access to medical care is limited by geography and now by states’ laws restricting abortion.
The Texas lawsuit questions mifepristone’s safety and the FDA’s approval process, claiming it used an accelerated review. Neither claim stands up to scrutiny; the FDA’s approval process took four years, and a 2013 review of the drug’s use, published in the medical journal Contraception, found that the drug combination’s failure to terminate pregnancy occurred in fewer than 5 percent of pregnant women, and fewer than 0.3 percent required hospitalization after treatment, the journal Nature reported.
As well, Nature notes, lawyers for the FDA write that the plaintiffs in the Texas case do not provide an example of a patient who might have suffered serious adverse effects because of the drug in its 20 years of use.
Prior to the current makeup of the U.S. Supreme Court, those assurances would likely have been enough to discourage the court’s interests in even considering the case.
At the same time, the FDA is taking flak from the left for its rules around mifepristone, in the form of a second lawsuit, this one filed by Washington state Attorney General Bob Ferguson, and the attorney generals of Oregon and 10 other states. The lawsuit seeks to force the FDA to drop restrictions it has on how the drug is prescribed and administered, regulations that aren’t required for the vast majority of other prescription medications.
Previous to the covid pandemic, mifepristone had to be administered in a clinic setting. That and other rules were relaxed; still the FDA has kept other requirements seen as complicating and delaying treatment within the 10-week window of its typical use.
Among the FDA rules, according to a commentary by Bloomberg Opinion’s Noah Feldman, in order to prescribe and distribute mifepristone, physicians and pharmacies must undergo special certification, a procedure required only for drugs with a serious risk of adverse effects, such as opioids, certain high-risk cancer drugs and high-dose sedatives. And patients must sign a form that reads: “I have decided to take mifepristone to end my pregnancy.” Again such signed declarations are not required for all but 60 of the more than 20,000 medications the FDA has approved.
The approval process and the requirement for a signed consent form, argues the lawsuit filed by Ferguson and the others, leaves those doctors, pharmacies and patients open to identification in the public and potential harassment and violence in states that have outlawed abortion and have passed laws to hold those participating in abortions legally responsible.
As well, because mifepristone is used to treat women who have suffered a miscarriage, the requirement that a woman sign a form declaring she has “decided” to end that pregnancy is an unconscionably cruel act of bureaucracy.
“This case is about whether it is improper and discriminatory for FDA to relegate mifepristone — a medication that has been used over 5 million times with very low rates of complications, very high rates of efficacy, and which is critical to the reproductive rights of the Plaintiff States’ residents, as well as visitors who travel to the Plaintiff States to seek abortion care — to the very limited class of dangerous drugs that are subject to (the risk strategy),” the complaint filed in Washington says.
The Texas lawsuit threatens a method of abortion that is safe, effective and more accessible than surgery, and one that is performed in the first trimester, a fact important to a majority of Americans. A 2022 poll by Pew Research found that 56 percent of respondents said that the stage of pregnancy should matter as to the legality of abortion.
Such sound arguments likely would have found agreement with a Supreme Court majority; a few years ago.
Now, the best hope may be that the justices, when the court does hear the issue, will take the competing lawsuits as an opportunity to leave things as they are.
Considering that about 60 percent of abortions in Washington state are medication abortions, the FDA’s approval of mifepristone — as imperfect and unnecessarily restrictive as it is — must be protected.
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