Advocates Urge Biden and FDA to Do More Ahead of Texas Abortion Pill Ruling

Eight months after the Supreme Court overturned Roe v Wade, the Biden administration is bracing for another ruling that could further restrict access to abortion across the country.

Administration officials are preparing to respond to a ruling from a conservative federal judge in the Northern District of Texas that could restrict one type of abortion pill—mifepristone—that has been used for decades in medication abortions. If the judge’s order does restrict access to mifepristone, it could also impact treatments for miscarriages, where the drug is used as well.

Lawyers at the Department of Justice and Health and Human services are watching the case closely and prepared to challenge the ruling, depending on how it comes down, the White House says.

In the meantime, many physicians and public health experts would like to see the Biden administration take bolder actions to make medication abortions more accessible.

“There’s a lot more the Biden Administration could have done and could still do,” says Ushma Upadhyay, a public health scientist and professor at the University of California, San Francisco.

Medication abortions make up more than half of all abortions conducted nationwide. They’ve been used for more than two decades in the United States, and the pills are considered medically safe for use around the world. The standard method in the U.S. involves two steps, administered through 10 weeks into a pregnancy. First, a patient takes mifepristone, which terminates the pregnancy, followed by misoprostol, a widely available medication used to treat stomach ulcers, which initiates contractions and expels the fetus.

Judge Matthew Kacsmaryk has been asked by anti-abortion medical groups to rule on whether the FDA followed its own procedures when it approved the use of mifepristone two decades ago, and when it reauthorized it in the intervening years. Biden Administration lawyers have argued in court that the parties that brought the lawsuit haven’t sufficiently shown they suffered injury or that they would be helped by the court’s intervention, especially given the fact that the drug already has been in wide use for more than 20 years.

“We are working closely with the Justice Department and the Department of Health and Human Services, as you all know, to be prepared for a range of potential outcomes that may come out of this,” White House Press Secretary Karine Jean-Pierre told reporters on Monday. “And we’ll be prepared to review and take actions to ensure the safety and the health care of women.”

After the Dobbs decision overturned Roe, more than a dozen states banned abortion entirely. Some states also blocked doctors from administering medication abortions. Public health organizations have worked to inform people in states with abortion bans about how to order pills for medication abortions they can conduct themselves at home.

The day the Supreme Court overturned Roe, Biden warned that if access is restricted for drugs used in medication abortions “maternal mortality will climb in America.” He directed the Department of Health and Human Services to ensure ”these critical medications are available to the fullest extent possible and that politicians cannot interfere in the decisions that should be made between a woman and her doctor.” In July and August, Biden issued executive orders instructing his Cabinet to do more to protect access to medication abortions.

The Biden Administration has taken various steps in recent years to make the pills more accessible. In 2021, the FDA allowed doctors to prescribe the medication remotely, without an in-person appointment, and for the medication to be mailed to patients, instead of having to be picked up in person at a pharmacy. The FDA decided to allow pharmacies to dispense mifepristone, if they got a special certification for the drug. In January, after more than a year of review, the FDA published new rules designed to allow more retail pharmacies to offer mifepristone. But even that shift came with new hurdles that doctors and patients have to get over before being able to use the drug.

Among other steps, the FDA required doctors to fill out a prescriber agreement form, which previously only went to the distributor of the medication, but now also goes to the pharmacy. For decades, the distributors have taken care to not let the names of medication abortion providers become public, for their safety from threats. Now that information will be in the hands of local pharmacies as well. The FDA also required both the provider and the patient to sign a form attesting that the clinician reviewed all of the risks of the medication, a form that isn’t used in other medications with long safety records.

Those hurdles should be cleared away for a drug that has a 23-year proven track record like mifepristone, Upadhyay says.

“All of these restrictions are based on stigma and politics,” Upadhyay says. “These restrictions impact people of color and those who are most marginalized. They’re the ones who are least able to travel or work outside of the system to get access to mifepristone, and they’re the most likely to be criminalized if they’re suspected of going outside the legal system.”

Read more: For People With Disabilities, Losing Abortion Access Can Be a Matter of Life or Death

Some officials in states with abortion bans seized on the FDA’s new actions and discouraged pharmacies from seeking certifications for mifepristone. In response, Biden issued a presidential memorandum on Jan. 22 instructing the secretaries of Homeland Security and Health and Human Services to issue new guidance that will support patients and doctors wanting to access the drug, regardless of where they live. That new guidance has not yet been released.

“It’s one step forward, two steps back,” agrees Elisa Wells, co-founder and co-director of Plan C, an organization focused on sharing information about how to access and take abortion pills. Her organization has been researching ways for women to receive abortion pills in all 50 states through mail order and telehealth appointments. She says the FDA made a step in the right direction when it authorized retail pharmacies to distribute medications for abortions.

“But in the process they created this whole new system of certification for pharmacies that doesn’t exist for other drugs,” she says.

The criticisms from some reproductive rights advocates echo those made in the weeks after the Dobbs ruling, when some Democrats complained that the Biden administration hadn’t acted swiftly enough to take urgent action in response.

Dr. Emily M. Godfrey, a family physician and associate professor of family medicine and obstetrics and gynecology at the University of Washington in Seattle, is part of a team working to figure out how thousands of physicians and clinicians should prescribe mifepristone in the massive university’s medical network after the FDA issued its new procedures in January. That work involves finding a way to ensure prescribers are certified with accessible individual pharmacies in Washington State and figuring out which pharmacies have their newly required FDA certifications, Godfrey says.

Those requirements are “not even in place for drugs that kill people.” says Dr. Godfrey, who noted that she prescribes drugs for diabetes, hypertension, chronic pain and opioids that, if used incorrectly, can be potentially very dangerous. But those drugs don’t require such complex steps be taken before being prescribed.

Dr. Godfrey thinks the Biden Administration should do what Canadian health authorities did in recent years and do away with the extra risk evaluation and mitigation strategy (REMS) restrictions. “I think the Biden administration needs to take a bold step and completely do away with the REMS and let mifepristone be prescribed the way all the medications that I prescribe every day to patients,” Dr. Godfrey says.

In the meantime, the White House is watching the court in Texas closely to see what kind of ruling the judge makes and whether that will attempt to restrict access to mifepristone. “The decision could be unprecedented, of course, and devastating to women’s health,” Jean-Pierre said.

There are other steps that the FDA could take, says Erica Chong, executive director of Reproductive Health Education in Family Medicine, which supports training in abortion procedures for family medicine doctors around the country.

The FDA could clearly tell physicians that they can prescribe abortion pills to patients in advance of needing to abort a pregnancy, so they have those on their shelf at home, if they need to use them. Also, the FDA could invite the manufacturer to add an indication for use in miscarriage management on the mifepristone label as well. And if the judge does rule in a way that tries to restrict mifepristone, the FDA could make clear to the public that existing stocks of mifepristone can still be distributed and used without criminal repercussions.

Chong and other public health advocates were hoping the FDA’s extra safety procedures for mifepristone “would just go away because there’s over 20 years of safety data in the U.S.—more if you look at international data. This is a very safe and effective drug.”