The Abortion Pill Legal Standoff Endangers Access to All Drugs

A ruling by a Texas judge has made the medication used in most medication abortions in the US legally unavailable for most women. Judge Reed O’Connor’s decision reinstates stringent Food and Drug Administration (FDA) guidelines that would force women to obtain the medication, mifepristone, in person from a medical provider rather than remotely with a telemedicine appointment, something that has become more widely used during the pandemic. The decision impacts patients who would have been prescribed the medication before they reach the 70-day pregnancy threshold; after that point, medication abortion isn’t advised. Supporters of the ruling say it protects women by ensuring they receive the pill after an in-person medical consultation, where providers screen for complications. Opponents say it puts women at risk by forcing them to make unnecessary trips to their healthcare providers.

The lawsuit challenging the FDA’s limitations on mifepristone access was brought last year by the American College of Obstetricians and Gynecologists and other groups, in part as a response to the Covid-19 pandemic, which made in-person visits to healthcare providers difficult for some. The new ruling effectively reverses the FDA’s easing of restrictions on mifepristone, which had been put in place during the pandemic. Nearly 4m women in the US have used the medication in the two decades since it was approved by the FDA.

In a statement, Jim Stansel, executive vice president of the Pharmaceutical Research and Manufacturers of America, or PhRMA, called the FDA the “gold standard for determining whether a medicine is safe and effective” and said the group has “serious concerns with any court substituting its opinion for the FDA’s expert approval decision-making.” Marcus Schabacker, president and CEO of the independent nonprofit organisation ECRI, said he is worried about the patient safety implications of the decision. With medication abortion in legal limbo, it creates ambiguity about what healthcare providers can and cannot do. “When the court steps in and creates that kind of uncertainty, it endangers patients. That’s what we worried about,” he says.

Even if mifepristone ultimately becomes unavailable in the US, medication abortion is still possible with just misoprostol, the other half of the two-pill regimen. This drug is typically taken 24 to 48 hours after mifepristone to dilate the cervix and cause contractions, which empties the womb. Though less effective than taking both pills, a misoprostol-only regimen is endorsed by the World Health Organization and American College of Obstetricians and Gynecologists as an acceptable alternative. The FDA could choose to exercise its enforcement discretion, meaning it would not enforce the restrictions set by the ruling, allowing providers to continue to prescribe the pill and dispense it through the mail.



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