The legal battle over abortion pills has harmed pregnancy care | STAT – STAT

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By Elizabeth SchmidtJune 13, 2024
The Supreme Court unanimously shut down one of many troubling tugs of war over access to abortion. By tossing out FDA v. Alliance for Hippocratic Medicine, it quashed the utterly mistaken notion that the Food and Drug Administration improperly approved mifepristone, a drug used for medical abortion, nearly a quarter century ago.
This Texas-based case, which sought to roll back access to one of two abortion medications, was not really about anti-abortion doctors supposedly being harmed by the government’s actions. It was about a political drive to unfairly question and restrict a longstanding, safe, and sometimes necessary medical treatment to end pregnancies.
Mifepristone’s safety record is firm: it has been used in more than 630 clinical trials, 420 of which were randomized and controlled, since the FDA initially approved it for pregnancy termination with a second drug (misoprostol) for up to 49 days of pregnancy. Given the millions of people in the U.S. who have used it successfully, the FDA approved its use for up to 70 days in 2016. The death rate from mifepristone is 0.0005% —the U.S. death rate from giving birth is 0.019% — and decades of research show a 0.4% risk of major complications from it, lower than with Tylenol or Viagra.
Despite that record, the FDA placed this medication under a Risk Evaluation and Mitigation Strategy (REMS) drug safety program, the FDA’s extra way of ensuring that a drug’s benefits outweigh its risks. Part of the this strategy meant that mifepristone had to be picked up in person at the doctor’s office.
The American College of Obstetricians and Gynecologists (ACOG) has advocated that the REMS restrictions aren’t necessary. Citing decades of evidence, the success of lifting the in-person dispensing requirement during the Covid-19 public health emergency, and a broad consensus of the medical community to underscore that mifepristone is safe, ACOG argues that the FDA requirements do not benefit patients. Furthermore, the mitigation strategy disproportionately burdens communities already facing structural barriers to care, including people of color and those living in health care and reproductive deserts.
Medical professionals also know that the risk of dying from a full-term pregnancy and childbirth in the United States is 14 times higher than that of dying from a legal abortion. Medication abortions without mifepristone may be less effective and result in nausea, diarrhea, chills, vomiting, or cramping.
Doctors rely on mifepristone for other uses, such as inducing labor and managing miscarriages, and when a fetus dies in utero. This medication helps keep patients as safe as possible during these processes. Mifepristone also may be helpful in treating fibroids.
The Texas case had caused enough concern over the availability of mifepristone that New York, like other states, began building a supply of misoprostol, the second in the two-drug regimen, in case mifepristone becomes unavailable. Some individuals have been obtaining personal doses of these medications from Europe.
Fortunately, the New York-based health system where I regularly prescribe mifepristone has not experienced a shortage of the medication since the Texas ruling. A stockpiling mentality, however well-intentioned, can be harmful because it squirrels away medications for future patients, which could make them less available for today’s. It’s not a sustainable solution because obstetricians need to be able to prescribe doses to patients before they expire and become unusable.
I hope that between the Supreme Court’s ruling and the country’s two largest drugstore chains preparing to dispense mifepristone at stores and via mail order, stockpiles won’t be necessary. The notion that both abortion medication and access are dwindling following the 2022 overturn of Roe v. Wade, has left OB-GYNs and their patients in chaos.
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In the tense run-up to the Supreme Court decision, OB-GYNs have seen their patients being denied insurance coverage for their desired method of managing miscarriages. Insurance companies have been denying coverage for uterine evacuation for miscarriage and also denying coverage for medical management of miscarriage. People have been forced into surgery or medication they don’t want.
The argument that the anti-abortion doctors who brought this case to court are the ones harmed by mifepristone was always unacceptable. In fact, their case has caused more harm because this unnecessary debate undermined patients’ abortion and pregnancy management options. Further limiting or losing mifepristone, a medical tool used in more than half of all U.S. abortions, would have been incredibly dangerous for patients.
Contrary to the opinion of a Texas court, based on now-retracted studies, the FDA did not take shortcuts to approve mifepristone in 2000, nor had it harmed the doctors who brought this case — even if those who seek to politicize and outlaw abortion say otherwise.
I for one am grateful that the Supreme Court was attentive to the scientific data, realities, and outcomes, just as the FDA was when it approved mifepristone more than 20 years ago. At least for now, one aspect of pregnancy care has been settled.
Elizabeth Schmidt, M.D., is the chief of family planning in the Department of Obstetrics and Gynecology for Northwell Health, and assistant professor of obstetrics and gynecology in the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell.
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