The lawsuit on which the judge ruled Friday argues the U.S. Food and Drug Administration’s approval process for mifepristone was flawed.

A federal judge in Texas issued a preliminary ruling suspending the federal government’s approval of a widely used abortion pill late Friday. The Biden administration within hours appealed the decision — one that could have ramifications for abortion access in every state, including Massachusetts. 

The judge, Matthew J. Kacsmaryk, ruled on a federal lawsuit filed by an anti-abortion Christian legal group, which argues the U.S. Food and Drug Administration’s approval process for mifepristone more than 20 years ago was flawed.

It is, however, complicated by a same-day ruling in a separate federal case: Attorneys general from several states, including Rhode Island, filed a lawsuit in Washington state, arguing the FDA is too strict in limiting the abortion drug. Judge Thomas O. Rice issued a conflicting ruling Friday for that case, ordering the FDA to make no changes to the availability of mifepristone. 

These contradictory rulings could bring the issue to the Supreme Court. 

Health Imperatives, a nonprofit with seven locations in southeastern Massachusetts, including New Bedford, is prepared to start providing medication abortion this summer after receiving state funding last year. Its president says the Texas ruling will not affect these plans.

“While we are deeply troubled by the Judge’s ruling, and hope that mifepristone will remain on the market or become available again as soon as possible, Health Imperatives still plans to offer medication for abortion services this summer,” Julia Kehoe, president of the nonprofit, said in an email Friday. “While the current regimen for medication abortion includes two drugs: mifepristone and misoprostol; abortion is still safe and effective with [misoprostol] alone, which is what we plan to offer as long as is necessary.” 

Other providers, like the Planned Parenthood League of Massachusetts, are also prepared to offer misoprostol only as they brace for the possibility of mifepristone being removed from the market. 

The ruling in Texas is the latest of several instances in which states or anti-abortion rights groups have sought to further curtail access to abortion since the Supreme Court overturned Roe v. Wade last June. Kacsmaryk was appointed by former President Donald Trump and has affiliations with the religious right, NPR reported

The plaintiffs alleged mifepristone does not meet federal standards to be prescribed, and their attorney portrayed the drug as dangerous, the Washington Post reported.  

Medication abortion (or abortion by pill) is safe and effective, per the American College of Obstetricians and Gynecologists. Since its FDA approval in 2000, mifepristone has been used by more than 3.7 million U.S. women, with serious complications being very rare, AP News reported

It’s also increasingly used nationally and in Massachusetts, where nearly 50% of abortions in 2021 were by pill — up from about 31% in 2016 and 24% in 2011, according to data from the Massachusetts Department of Public Health.

For the Southeast region, which includes the South Coast, the proportion of medication abortions is greater: nearly 57% in 2021, up from about 50% in 2020. 

The pills are approved for use up to the 10th week of pregnancy. In 2021, nearly 73% of abortions at zero to eight weeks of gestation were done by medication in Massachusetts.

Medication abortion involves the drugs mifepristone and misoprostol. Mifepristone dilates the cervix and blocks progesterone, while misoprostol causes cramping and bleeding that expels the pregnancy tissue. 

“Mifepristone has really changed the way medication abortion is provided in the United States,” said Dr. Danielle Roncari, an OB-GYN and vice president of medical services for the Planned Parenthood League of Massachusetts. “It’s really about choice … some patients prefer the privacy of medication abortion … for some patients, it’s more akin to what would happen during a miscarriage, so it feels more natural to them.”

Abortion pills can be taken in a doctor’s office or clinic, or sent by mail following a telehealth visit, which can help reduce barriers to access presented by transportation costs and distance. It is a more feasible option for residents in southeastern Massachusetts or the Cape and Islands, as the nearest abortion clinic is in Attleboro or across state lines in Providence.

The medications in combination have a success rate of up to 99%, Roncari said in an interview last month, but the misoprostol-only regimen is slightly less effective depending on the gestational age. Additionally, abortions with both medications can occur within a few hours, but it can take longer when only misoprostol is used. 

Gov. Maura Healey on Friday pledged to take immediate action to protect access to this form of abortion care in Massachusetts.

“This is yet another attempt by extremists to ban abortion nationwide. But we are prepared to take immediate action to protect access to this important medication,” she said in a statement. “Patients in Massachusetts will continue to have access to mifepristone. We stand for civil rights and freedom, and we will always protect access to reproductive health care.” 

Healey has taken a strong stand for abortion access, signing a letter with 13 Democratic governors last month to major pharmacies, demanding to know their plans for dispensing abortion pills. Last month, she also reminded pharmacies that they are required to carry mifepristone despite efforts to ban it.

“This is incredibly upsetting for somebody that’s been practicing in this field for as long as I have,” said Roncari, who also serves as the director of family planning at Tufts Medical Center. “We have lots of good research, lots of good evidence, lots of good patient experience around mifepristone and misoprostol.”

Dr. Jack Resneck Jr., president of the American Medical Association, said in a statement that Kacsmaryk’s decision “flies in the face of science”: “The court’s disregard for well-established scientific facts in favor of speculative allegations and ideological assertions will cause harm to our patients and undermines the health of the nation. By rejecting medical facts, the court has intruded into the exam room and has intervened in decisions that belong to patients and physicians.”

The FDA on Saturday tweeted a statement, noting the agency has appealed the ruling: “FDA stands behind its determination that mifepristone is safe and effective under its approved conditions of use for medical termination of early pregnancy, and believes patients should have access to FDA-approved medications.” 

Regardless of the outcome of these cases, there is also concern Kacsmaryk’s ruling could confuse the public on what rights they have regarding abortion care. 

“This decision could have unprecedented impacts on medication abortion dispensing, and create more confusion around the legality of care than ever before,” said Reproductive Equity Now, a Massachusetts-based reproductive rights organization, in an email to supporters earlier this year on the Texas case. 

Massachusetts Attorney General Andrea Campbell said Friday that her office will use its full legal authority to protect abortion access, and that people can call the office’s confidential hotline at 833-309-6301 for questions about medication abortion.

As of now, access to mifepristone remains unchanged and legal in Massachusetts. On Monday, Healey will hold a press conference outlining her plan to keep the medication accessible.

Email Anastasia E. Lennon at

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