The abortion pills mifepristone and misoprostol. JACKIE MOLLOY/NYT
By Sonel Cutler Globe Correspondent, Updated April 21, 2023, 1 hour ago
The Supreme Court is expected to issue a decision Friday on a controversial case that could threaten access to a widely used abortion pill and significantly impact the Food and Drug Administration’s authority to regulate health services like vaccines and contraceptives.
US District Judge Matthew Kacsmaryk, a Trump appointee, issued the April 7 ruling currently under consideration by the Supreme Court. Kacsmaryk granted an injunction against the FDA’s approval of mifepristone, the most common method of abortion in the country, more than two decades after its initial approval.
The court will also consider an almost simultaneous opposing ruling from a judge in Washington state barring the FDA from limiting access to mifepristone in 17 states that filed a lawsuit to expand the pill’s accessibility.
As political leaders and women’s health advocates raise alarms, here’s what we know about what will be a critical judicial decision in the ongoing fight over abortion care in the United States.
What’s the latest? Is mifepristone still available?
As of Friday, mifepristone still has lawful uses and remains available in some form in 37 states, even those with abortion restrictions. The Supreme Court on April 14 paused the ruling from the federal judge in Texas that invalidated the FDA’s 23-year-old approval of the pill, temporarily restoring full access to mifepristone while it reviews Kacsmaryk’s ruling.
The Supreme Court’s order also stopped additional restrictions that would have taken effect last Saturday after the Fifth Circuit Court of Appeals ruled April 12 that the Food and Drug Administration’s approval of mifepristone remains valid, but not its 2016 decision to remove some restrictions. The judges had reimposed those restrictions, ruling that mifepristone may be provided only for pregnancies of seven weeks or shorter, that only physicians may prescribe it, and that it may not be mailed to patients and must be picked up in person instead.
On Wednesday, the Supreme Court temporarily extended women’s access to mifepristone until Friday while the justices consider whether to allow the restrictions to take effect as a legal challenge to the medication’s FDA approval continues.
Mifepristone is used in more than half of all abortions in the country, often in conjunction with another abortion pill, misoprostol. Access to misoprostol is not currently at risk under the Texas ruling and the pill can be used alone to induce an abortion, but it is more effective when taken with mifepristone.
How Massachusetts has responded
Governor Maura Healey reiterated last week that her administration will do all it can to ensure medication abortions remain legal and accessible in Massachusetts.
Healy announced April 10 that the state is stockpiling mifepristone and directed the University of Massachusetts Amherst to place an order for 15,000 doses, or over a year’s worth of the drug.
In addition, Healey issued an executive order the same day confirming that medical abortion and mifepristone are covered by a state law passed last year that helps shield providers from out-of-state prosecution.
Although abortions are clearly legal under Massachusetts law, some legal experts cautioned that federal decisions can supersede those protections.
Why experts are criticizing the Texas ruling
Critics of the ruling argue that, in siding with the plaintiff — a religious liberty legal group — Kacsmaryk ignored several questionable arguments and factual inaccuracies in the suit, including that the FDA didn’t properly review mifepristone’s safety before approving it for the market. Several experts said the ruling is a warning sign that the courts are becoming dangerously politicized at an alarming rate.
Major medical groups, including the American College of Obstetricians and Gynecologists, filed a brief to the court saying mifepristone has been proven safe and effective for the millions of women that have used the drug in the last 23 years. “This is not an opinion — it is a fact based on hundreds of medical studies and vast amounts of data amassed over the course of two decades,” the filing read.
Additionally medical experts noted multiple dubious statements in Kacsmaryk’s decision memo, including the use of a term, “unborn human,” used by antiabortion activists to minimize the role of the person carrying the pregnancy and unsubstantiated claims that “chemical abortion drugs can overwhelm the medical system.”
How does the Washington state ruling factor in to the Texas decision?
Just an hour after the Texas ruling, Judge Thomas O. Rice, an Obama appointee, issued a conflicting decision prohibiting the FDA from limiting mifepristone access in 17 Democrat-led states and Washington, D.C., which had filed a lawsuit to keep the pill on the market.
The opposing ruling out of Washington state put more pressure on the Supreme Court to fast-track its decision on the issue.
Massachusetts is not involved in the lawsuit protecting the availability of mifepristone in those 17 states, and a spokesperson for Attorney General Andrea Campbell said the state does not need to be party to it to ensure access to the pill because of an existing shield law protecting abortion providers and patients.
Other potential impacts of the Supreme Court’s ruling
Beyond making mifepristone more difficult to obtain for thousands of women across the country seeking abortion care, experts argue that affirming Kacsmaryk’s ruling could set another worrying precedent. A judicial override of the FDA’s approval of mifepristone would undermine the organization’s scientific expertise and authority, opening the door for any future approval of medications to be subjected to the judiciary, critics say.
The ruling could also create a chilling effect for pharmaceutical companies, which would have to weigh whether their efforts to get health products approved by the FDA are worth the risk if judges can overturn regulatory processes from the bench.
There is practically no precedent for a lone judge overruling the medical decisions of the Food and Drug Administration.
Abortion providers have also raised concerns about how forcing people to use only misoprostol for medication abortions could place a heavier burden on lower-income women.
An abortion using misoprostol alone can take up to 14 hours, compared with two hours for the combination treatment with mifepristone, experts said. Women using the one-drug method may also need follow-up procedures to remove any remaining tissue, which would require child care options and time off work.
Sonel Cutler can be reached at sonel.cutler@globe.com. Follow her on Twitter @cutler_sonel.
