BALTIMORE — A decision is due any day from a federal court in Texas that could have sweeping repercussions on abortion access across the country — including in states, like Maryland, where the procedure is protected.
Several anti-abortion groups and doctors are suing the U.S. Food and Drug Administration to revoke its 22-year-old approval of the drug mifepristone, which is used in combination with the drug misoprostol in 98% of medication abortions in the U.S.
Until a ruling is made in the case ― which was filed in November 2022 by the Alliance Defending Freedom legal group ― it remains unclear how the lawsuit will affect Maryland, said Karen Nelson, president and CEO of Planned Parenthood of Maryland.
But in case mifepristone is pulled from the market — what Nelson called the “worst-case scenario” ― staff members at Planned Parenthood clinics in Maryland are being trained on how to provide abortion care using only misoprostol (pronounced me ZOH prost’ ol).
The one-drug regimen is a safe and effective way of terminating a pregnancy, Nelson said, but it’s frustrating to prepare for a world where doctors and nurses wouldn’t be allowed to prescribe the two-drug regimen, which is more effective and has less unpleasant effects.
“Again, we have politicians and judges getting in the way of processes, medical decision-making and choices about standards of care that should be left between the patient and the doctor,” Nelson said.
Reproductive rights advocates have accused the Alliance Defending Freedom of “court shopping” before deciding to file the suit in the Northern District of Texas. The judge in the case, Matthew Kacsmaryk, was appointed by former President Donald Trump and previously worked for the conservative legal group First Liberty Institute.
According to the Guttmacher Institute, a research nonprofit that aims to advance sexual and reproductive health and rights, medication abortions now account for more than half of U.S. abortions.
In Maryland Planned Parenthood clinics, Nelson estimated, about 60% of abortions are provided by pill.
For more than two decades, the two-pill regimen has been considered the “gold standard” of medical abortion care, said Dr. Jessica Lee, an OB-GYN at the University of Maryland Medical Center and a professor at the University of Maryland School of Medicine.
Mifepristone (pronounced meh FE’ pri-stone), was approved in 2000 by the FDA as a method of abortion. It is a common drug that has many uses in gynecology outside of abortion, Lee said, including managing miscarriages and in labor and delivery.
But if the medication becomes unavailable following the Texas ruling, she and her colleagues are prepared to start providing care using only misoprostol, she said.
The one-drug regimen is used around the world to terminate pregnancies, she said. It’s also commonly used to manage miscarriages and induce labor, according to a report issued last week by the Society of Family Planning, a nonprofit that shares research on abortion and contraception.
However, a patient could have to take multiple doses of misoprostol for it to be effective alone, Lee said. Side effects are similar to those experienced with the combined mifepristone and misoprostol regimen — nausea, vomiting, cramping and diarrhea — but they could last for a longer period of time, according to the Society of Family Planning report.
Since the U.S. Supreme Court struck down federal abortion protections in the Dobbs v. Jackson case last June, Planned Parenthood in Maryland is on track to provide abortion care to about 20% more patients this year, compared to last year, Nelson said. About half of that increase is from patients who are coming from outside of the state, she said.
Although Planned Parenthood has always seen patients from states bordering Maryland, such as Delaware and West Virginia, Nelson said, its clinics are now seeing patients from almost two dozen different states.
Since the Dobbs decision, 12 states have passed near-total abortion bans and four have passed laws prohibiting the procedure after a specific point in pregnancy, according to the Guttmacher Institute. Abortions also have paused in Wisconsin — where a legal challenge to a pre-Roe ban is pending in state court — and North Dakota, where there are no longer any abortion clinics.
If the Texas ruling further restricts abortion access in some states, even more patients could wind up coming to Maryland for care, Nelson said.
But no matter what the ruling is, she expects that patients will be confused about what services remain available.
“Planned Parenthood will be providing a full range of reproductive health care, including abortion care,” she said. “I just want to say to our patients, call us if there’s any questions. Go to our website, or pick up the phone and call us, and we’ll explain it all to you.”
If Kacsmaryk rules in favor of the Alliance Defending Freedom, it will be the first time that a court has ordered a drug to be taken off the market over the objection of the FDA, said Michelle Siri, executive director of the Women’s Law Center of Maryland.
According to Siri, it’s an unprecedented lawsuit — but not a surprising one for anti-abortion advocates to file.
“It completely undermines the whole point of having the FDA in the scientific process,” she said. “It really is creating a precedent where politicians and political actors can make decisions that should be made by scientists and based on scientific evidence.”
The case could have future implications for other FDA-approved drugs and procedures, such as contraception and gender-affirming care, she said.
If Kacsmaryk decides against the FDA, Siri said she hopes the federal government will ask for a stay while the case is appealed, extending the amount of time mifepristone is accessible.
But since the lawsuit would be appealed to the 5th U.S. Circuit Court of Appeals — the most politically conservative circuit in the country — Siri isn’t optimistic that the decision will be reversed. She also doesn’t have much faith in the Supreme Court making a different decision.
“We can’t say it enough, right?” she said. “Trust our doctors, trust our patients, trust women.”
A dozen states with Democratic attorneys general filed their own lawsuit Feb. 24 against the FDA, arguing that the federal agency regulates mifepristone in a way that’s excessively strict.
The suit, filed in a federal district court in Washington state, doesn’t explicitly address the potential consequences of the Texas case. Instead, it primarily argues that the court should order the FDA to remove extra rules it applies to mifepristone, and asks the court to declare the agency’s approval of the drug “lawful and valid.”
But legal experts say the lawsuit could set up a scenario where there are two conflicting federal rulings, potentially preserving access to mifepristone until the Supreme Court addresses the issue.
Maryland is not part of the Democratic coalition that filed the lawsuit. It remains to be seen whether Maryland’s attorney general, Anthony Brown — a Democrat — will file his own lawsuit. A spokesperson for Brown said the office had no comment when contacted Thursday by The Baltimore Sun.
Maryland Gov. Wes Moore, a Democrat, has voiced his support for abortion access since the early days of his campaign and has doubled down since entering office in January.
At several turns, Moore has publicly promised that Maryland will be a “safe haven for abortion rights” during his administration. He is supporting a package of bills moving through the General Assembly that seek to expand access and protect patient and provider data, including legislation to:
—Allow Marylanders to vote during the 2024 election to enshrine the right to abortion access in the state constitution (House Bill 705/Senate Bill 798);
—Require Maryland’s public colleges and universities to develop plans to provide student access to emergency contraception and abortion services (House Bill 477/Senate Bill 341); and
—Prohibit Maryland from aiding other states’ criminal investigations of and court proceedings against patients and providers involved in abortions (Senate Bill 859/House Bill 808).
A fourth bill, sponsored in the Senate by Democrat Shelly Hettleman of Baltimore County and in the House by Democrat Sandy Rosenberg of Baltimore, would, among several measures, require a patient’s consent for the transfer of pharmacy dispensing data if they are prescribed mifepristone. It’s Senate Bill and House Bill 812.
Hettleman told The Sun that the Texas decision could have a “dramatic, dramatic effect on people’s ability to get an abortion.”
“We know that over half of people use [this] medication to do a medication abortion, so it substantially alters the landscape even more dramatically in places like Maryland,” she said Friday.
Because this is a federal court decision, the General Assembly is limited in its ability to intervene to maintain protections as it did when lawmakers expanded access ahead of the decision last year that overturned Roe v. Wade.
The Abortion Care Access Act passed last year intends to increase the number of abortion providers in Maryland and requires the state to annually budget $3.5 million to fund a training program for clinicians interested in offering abortion services. The law went into effect in July.
Maryland Department of Health spokesman Chase Cook said that the agency is drafting a request for applications to fund an abortion care training provider to officially start that instruction.
Cook said that while the consequences of the pending court decision would be “far-reaching,” Moore has declared that the reproductive freedom of Marylanders “are nonnegotiable.”
“Maryland’s gonna lead on this issue,” Moore told The Sun in an interview Tuesday at the Banneker-Douglass Museum in Annapolis. “When we say that we want to ensure that Maryland is a safe haven for abortion rights, it means that we are going to look at and explore all means to make sure that that is the case.”
———
(Baltimore Sun reporter Maya Lora contributed to this article.)
———
