Massachusetts providers are preparing for the impact of a Texas antiabortion lawsuit that could limit access to medication-assisted abortion, a major change that would mark the first time abortion access would be restricted in the state since the Supreme Court overturned Roe v. Wade last June.
The federal case, brought in the Northern District Court of Texas by the group Alliance for Hippocratic Medicine, questions the Food and Drug Administration’s approval 23 years ago of mifepristone, a drug used in combination with another medication in both abortion and early miscarriage care.
The judge’s ruling, and the FDA’s response, will largely dictate what the suit might mean for Massachusetts, and there are a variety of possible outcomes.
At a baseline, abortion will still remain legal in Massachusetts. However, the case may result in providers across the country no longer being able to offer abortion care via telehealth and could lay the groundwork for effectively eliminating medication-assisted abortions entirely in Massachusetts and across the country, experts said. More women here may have to seek surgical procedures that cost more, are less widely available, and put further strain on an already overburdened health care system.
“Just because we’re in Massachusetts doesn’t mean the threat isn’t knocking at our front door,” said Rebecca Hart Holder, president of Reproductive Equity Now, a Massachusetts-based advocacy group.
The decision is likely to be appealed if it restricts access, but would still have an immediate impact as advocates work to take the next step in the legal process
In 2021, 49.48 percent of all abortions in Massachusetts were performed via medication. The two-drug regimen includes mifepristone, which causes the uterine lining to shed, and misoprostol, which causes the uterus to contract. Together, the drugs have a greater than 99 percent safety rating, and are 94 to 99 percent effective in ending pregnancy.
Medical abortion is FDA-approved through the first 70 days — or 10 weeks — of pregnancy, though many doctors prescribe it through 11 weeks of pregnancy.
While mifepristone has long been accessible in-person from providers, the FDA in December 2021 allowed the drug to be sent by mail — formalizing an easing of restrictions implemented during the pandemic and opening up telemedicine appointments for abortion care.
That landscape might soon shift. US District Court Judge Matthew Kacsmaryk of Texas, who was appointed by former president Donald Trump and is known for his conservative views, could order the FDA to reinstate the restrictions it lifted in 2021, effectively banning doctors from prescribing mifepristone via telehealth
Such a decision would limit access to abortions in parts of Massachusetts that lack brick-and-mortar clinics, such as Berkshire County, Hart Holder said.
The judge could also order the FDA to completely withdraw approval of mifepristone — the first time a court would revoke the authorization of an FDA-approved drug.
Dr. Katherine Pocius, medical director of family planning at Massachusetts General Hospital, said without access to mifepristone, providers will be forced to offer their patients misoprostol alone, for medical management of both abortion and early miscarriage care, in which a pregnancy ends in the first trimester but is not expelled by the body.
Misoprostol alone, however, is less effective. The need for a surgical procedure after a medical abortion or medical management of an early pregnancy loss is less than 5 percent when using both drugs. With misoprostol alone, the need for surgical intervention can rise to 15 percent, depending on the dosage. Increasing the dose improves the efficacy of misoprostol alone but can increase several unpleasant side effects, including gastrointestinal problems and fever.
“We are going to be forced to offer patients with abortion care and miscarriage management a less effective method based on nothing scientific,” Pocius said. “It is a huge disservice to the population.”
If mifepristone becomes unavailable, providers and clinics will likely consider changing their protocol to follow up earlier with patients, given the higher failure rate of the one-drug regimen. Currently, providers recommend patients take a home pregnancy test in a month — about how long it takes for pregnancy hormones to become undetectable following a miscarriage or abortion. With misoprostol alone, patients may have to come in sooner for blood tests or ultrasounds.
Misoprostol can also cause severe birth defects, in cases where the drug is administered but the pregnancy remains, further necessitating earlier follow-up care.
Given the lower efficacy rate, more patients may choose surgical options, such as a suction dilation and curettage, known as a suction D&C, in which a provider opens the cervix and places a tube inside to remove pregnancy tissue.
Dr. Alisa Goldberg, vice president of clinical training and research for Planned Parenthood of Massachusetts, said Planned Parenthood could likely accommodate an incremental increase in surgical cases.
However, if the majority of the abortions that are now medically managed change to surgical abortions, that could strain already overburdened health care facilities.
“We are already working at capacity at MGH,” Pocius said. “To add more surgical cases is really hard. We’re committed to abortion care and miscarriage management, but it will take a lot of resources if we need to increase surgical management options.”
Dr. Erika Werner, chair of obstetrics and gynecology at Tufts Medical Center and Tufts Medical School, and chair of the Society of Maternal-Fetal Medicine’s Health Policy and Advocacy Committee, said Tufts is looking to increase operating room availability for abortion and miscarriage procedures, not only because of a potential increase in surgical cases locally, but from increased cases coming to Massachusetts from states with even fewer options.
Werner said they have also made the ER, urgent care centers, and doctor’s offices aware that they might see more patients from abortions or miscarriages that are not effectively ended with the one drug.
“And it’s going to drive up health care costs,” Werner said. “A D&C is so much more expensive than mifepristone and misoprostol. Particularly in a state like Massachusetts, where some abortion care is covered, it’s going to cost [insurers] more.”
Some providers worry that the judge could go even further in his decision, referencing an 1873 law known as the Comstock Act, which forbade the US Postal Service from delivering medication for abortion. While the current case is focused on mifepristone, invoking the Comstock Act could imperil misoprostol in future cases.
“This is what is terrifying about lawsuits like this,” said Dr. Katharine White, a complex family planning specialist at Boston Medical Center and associate professor of obstetrics and gynecology at the Boston University School of Medicine. “Even in a state whose government has been clear about what rights the citizens have, we can be affected by a decision that happens in Texas.”
Beyond abortion and miscarriage care, losing access to one or both drugs could also imperil their use for other conditions. At higher doses, mifepristone is used to treat Cushing Disease, a condition where the body produces too much of a stress hormone. Misoprostol is used to induce labor, and treat postpartum hemorrhages. And mifepristone and misoprostol can also both be used to prep the cervix for gynecological procedures.
Predictions about the impact of a decision come with many caveats. If the judge rules in favor of the plaintiffs’ argument that the FDA should never have approved the drug, it is unclear what the mechanism would be for withdrawing a drug’s approval or removing it from the market. The Biden administration may intervene in some way that might limit the ruling. It is also unclear how the ruling will be worded, and if the ruling would affect all manufacturers of mifepristone, or if generics could still be produced. It’s unclear, too, if the wording of the decision would bar mifepristone for all uses or just for abortion. A ruling that prohibits access is likely to be appealed, which further muddies the result of the pending decision.
But, fundamentally, the outcome will sow further confusion around what abortion care is still accessible. Already, nearly half of US adults are unsure if medication abortion is currently legal where they live, according to a recent survey.
A ruling could also create confusion for providers, who don’t yet have a clear understanding of how to handle the Texas decision, whatever it may be. Several said they are in close contact with hospital lawyers to know what the ruling will mean for how they should practice. Procedures could differ by institution, depending on individual comfort levels with risk.
White said the situation may also be very volatile, with changes coming every day. Until then, providers are on edge, waiting for a decision.
“It’s the first thing I Google every morning,” White said.