What Happens to Abortion Pills If a Judge Bans Mifepristone?

<p>Verywell Health / Jessica Olah</p>

Verywell Health / Jessica Olah

  • A federal court in Texas is considering a case that would require the FDA to suspend or restrict its approval of a key abortion drug, mifepristone.

  • Mifepristone is one of two drugs that comprise the most common method of medication abortion.

  • Misoprostol, the second drug, is considered safe and effective when used alone in off-label abortion care.

A federal judge in Texas will soon issue a ruling that could restrict or end access to the abortion drug mifepristone, including in states where abortion is legal.

A coalition of anti-abortion groups is asking U.S. District Judge Matthew Kacsmaryk to force the Food and Drug Administration (FDA) to withdraw its approval of mifepristone during a hearing this week.

“This will mean that the most common way of providing abortions in this country, with over two decades of rigorous scientific testing providing evidence of its safety, will no longer be accessible to people throughout this country, including in states that have overwhelmingly supported abortion access such as New York, California, Massachusetts, and Illinois,” said Leah Coplon, CNM, MPH, a nurse-midwife and Director of Clinical Operations at Abortion on Demand.

Medication abortion accounts for more than half of the abortions reported in the United States each year. The regimen involves taking two drugs—mifepristone and misoprostol. Mifepristone, known by its brand name Mifeprex, stops the pregnancy from progressing by blocking the hormone progesterone. Misoprostol then empties the uterus.

But taking a few doses of misoprostol alone is safe and nearly as effective as the two-drug regimen. The FDA hasn’t approved a misoprostol-only abortion regimen, but major medical organizations say providers can prescribe it off-label for inducing abortion up to 10 weeks of pregnancy. The risk of adverse events is less than 2%.

Is Using Misoprostol Alone Safe and Effective for a Medication Abortion?

A February study, the first to look at the use of misoprostol for abortions in the U.S., found the misoprostol-only method to be 88% effective without intervention. Studies from other countries have reported efficacy rates as high as 99% and the World Health Organization cites it as a good alternative when mifepristone is unavailable.

In the standard medication abortion, mifepristone prepares the cervix for misoprostol. Without that first step, the process can take as long as five days to complete, said Caitlin Blau, DO, a family physician and abortion care expert at Blue Mountain Clinic in Missoula, Montana.

“It may include a little bit more physical discomfort, and requires monitoring and follow-up to make sure that the process is complete, which is true of the standard regimen as well,” Blau told Verywell. “Why would we want a patient to have cramping and bleeding for several days and be uncomfortable when there’s a better alternative?”

The efficacy of misoprostol varies depending on the dosage and the way its administered. The National Abortion Federation recommends giving at least three doses three hours apart until the pregnancy has passed.

Sometimes, though, it takes more than three doses for the regimen to be effective, Blau said. In that case, it’s important that patients can access additional pills. She said it’s fairly easy to fill misoprostol prescriptions in most U.S. pharmacies.

Abortion On Demand, a telehealth company that provides abortion medications by mail, will also offer a misoprostol-only option to its patients, according to Coplon. “In anticipation of the ruling, I think sharing the word that misoprostol-only abortions are safe and effective and that we cannot stop fighting for all those seeking care is important,” she said.

Planned Parenthood already offers its patients the option to take misoprostol alone, according to Bhavik Kumar, MD, MPH, a family physician and Medical Director for Primary and Trans Care at Planned Parenthood Gulf Coast.

How Will Banning Mifepristone Affect Abortion Access?

Despite the effectiveness of a misoprostol-only regimen, reproductive rights advocates say a ruling that disrupts access to mifepristone would narrow options for patients at a time when abortion is restricted or totally banned in many states.

“Without the use of mifepristone, it takes away a great option for patients to be able to choose,” Kumar told Verywell. “[My patients] would get to decide what their priorities are what’s best for them and what makes sense for them. And so not having this option is a real loss for many patients.”

The lawsuit was brought by the legal group Alliance Defending Freedom, which represents antiabortion organizations and four doctors who say they’ve treated patients with mifepristone. The group claims the FDA approved a “dangerous drug regimen” without sufficiently studying it. They also object to moves to make medication abortion more accessible, including by mail delivery.

Lawyers from the Justice Department, representing the FDA and a company that makes mifepristone, cited decades of scientific research on the safety and efficacy of the drug, the New York Times reported. The lawyers also noted mifepristone has been regulated more closely than most other drugs under the FDA’s Risk Evaluation and Mitigation Strategy (REMS) safety plan.

According to the American Medical Association, mifepristone is one of the best-studied medications in the U.S. There have been more than 630 clinical trials, including 420 randomized controlled studies, involving mifepristone.

Serious adverse events—blood transfusion, hospital admission, or infection—occur in about 0.5% of medication abortions.

“This means medication abortion with mifepristone and misoprostol has a better safety profile than other commonly used medications like Tylenol or Viagra,” said Lauren Ralph, PhD, MPH, associate professor in the department of obstetrics, gynecology and reproductive sciences at the University of California, San Francisco.

If Judge Kacsmaryk sides with the anti-abortion groups, it would be the first time a court has ordered the government to withdraw or suspend approval of a longstanding medication against objections from the FDA and the drug’s manufacturer. The move could also have far-reaching implications for the approval and regulatory process for drugs.

What Happens If the Abortion Pill Is Banned?

With increased restrictions on medication abortion, Kumar said he expects more patients to travel out of state to seek surgical procedures in states where abortion is still legal. That could swamp clinics, forcing people to wait longer to get care.

Restricted access and further anti-abortion litigation could dissuade people from pursuing abortion care when they need it, he said.

“The reality is banning abortion never stops the need for abortion,” Kumar said at a press briefing. “As a physician, it is my ethical duty to ensure that care is safe, patient-centered, and accessible. Attacks like this on a critical and safe medication make my job and that of other compassionate healthcare providers much more difficult.”

If the Texas court suspends the use of mifepristone, people may be able to continue accessing the two-drug combination from organizations like Aid Access, which ships the drugs from a pharmacy in India.

For now, patients can still access the standard medication abortion regimen through their health providers and mail-order telehealth companies in states where abortion is legal.

“The most important thing to know is that we as your local abortion providers and abortion clinics are here for you,” Blau said. “We’re fighting for you and we’re ready to care for you.”

The Miscarriage and Abortion Hotline is a free resource that anyone in any state can access. It is staffed by abortion who providers who offer medical advice to people going through abortion or miscarriage. Telehealth companies including Plan C, Abortion on Demand, Just the Pill, Hey Jane, and Carafem offer video visits with providers and medication abortion by mail.