Are federal rules that limit access to “medical abortion” justified?

According to the American Civil Liberties Union (ACLU), the answer is no.

Earlier this month, the ACLU filed a lawsuit against the U.S. Food and Drug Administration (FDA), challenging regulations that restrict access to the drug mifepristone.

Mifepristone is marketed in the United States under the brand name Mifeprex.

It can be administered in combination with the drug misoprostol to induce miscarriage.

The FDA has determined that the procedure provides a safe and effective way for patients to end a pregnancy in the first 10 weeks.

It offers an alternative to those who cannot access or prefer not to undergo so-called “surgical abortion,” a procedure in which miscarriage is induced through mechanical means.

Under current FDA rules , prescriptions for Mifeprex cannot be filled at retail pharmacies.

Instead, the “abortion pill” can only be dispensed in doctor’s offices, clinics, and hospitals by providers that have undergone a special certification process.

The ACLU states that these requirements are “medically unnecessary” and “burdensome.”

Many healthcare professionals and researchers agree.

In an article published in the New England Journal of Medicine in February, members of the Mifeprex REMS Study Group called for the FDA rules to be withdrawn.

“Mifeprex is extremely safe to use. Serious complications occur in only 0.01% to 0.3% of cases. The rates vary a bit by study and by complication type, but all are very, very low,” Kelly Cleland, MPA, MPH, research specialist in the Office of Population Research (OPR) at Princeton University and member of the Mifeprex REMS Study Group, told Healthline.

“The fact that these restrictions are still in place is based on political, not medical, reasoning,” she added.

Low risk of serious side effects

To enhance drug safety, the FDA has the power to impose a Risk Evaluation and Mitigation Strategy (REMS), or a set of restrictions on how a drug can be dispensed and administered.

“It’s intended for drugs that have serious potential risks, particularly if used by the wrong people or in the wrong dose or without the proper supervision by a clinician. But mifepristone doesn’t fit that profile. It’s not actually a dangerous drug,” Dr. Elizabeth Raymond, senior medical associate at Gynuity Health Projects and member of the Mifeprex REMS Study Group, told Healthline.

Among the millions of Americans that have used Mifeprex, only 19 deaths associated with the drug have been reported.

In fact, the use of Mifeprex poses much lower risk of death than pregnancy itself does.

Nonfatal serious side effects are also rare and usually treatable.

When it comes to addressing the low risk of serious side effects, Raymond told Healthline that the FDA restrictions on Mifeprex are unlikely to help.

“One of the key REMS provisions is that the drug must be dispensed to the patient in a clinic, hospital, or doctor’s office. But it doesn’t say that it must be taken there. So women can take it and ingest it at home,” Raymond said.

“If a woman were to have a complication, it wouldn’t occur until quite some time after, when she’s at home,” she continued. “So from that perspective, the REMS just doesn’t make sense.”

Restrictions pose barrier to access

The FDA restrictions on Mifeprex make it harder for patients to access medical abortion and limit the ability of clinicians to provide it.

“I think the biggest impact is for women who live in rural areas or areas without abortion clinics nearby. These areas often also have laws that place multiple barriers in the way of accessing abortion, such as waiting periods, so the burdens and hurdles compound for those who need to travel long distances to get abortion care,” Cleland said.

“If a healthcare provider can call in a prescription for Mifeprex so that the woman can pick it up at a pharmacy near her, it reduces the burdens of time, expense, needing to take extra time off from work, needing to find additional child care, etcetera. These burdens are incredibly significant for many women,” she added.

One of the plaintiffs in the ACLU’s case is Dr. Graham Chelius, a physician who works on the island of Kauai in the Hawaiian Islands, where there are no surgical abortion providers.

While Chelius is willing to provide medical abortion, he cannot stock Mifeprex at the hospital where he works due to the objections of some colleagues.

As a result, patients must fly to another island to access abortion care.

In some cases, patients might try to access mifepristone and misoprostol outside the U.S. healthcare system entirely.

“There’s a variety of evidence that women in the United States are interested in abortion outside the healthcare system. For example, there are lots of Google searches coming from America looking for that option, and there are actually foreign websites that will sell abortion drugs in the United States,” Raymond told Healthline.

In a study published online last week, Raymond and colleagues ordered 22 products from 18 online vendors of abortion pills and received 20 by mail.

After sending those products to a laboratory for testing, they found that all of the pills labeled as mifepristone contained the correct amount of that drug.

The misoprostol pills also contained misoprostol, although not always at the labeled dose.

The investigators reported some challenges in the ordering process, including a potential lack of security in the transfer of financial information.

“Google searches, the proliferation of these websites, and survey data show that some women are doing this,” Raymond said. “And to me, what that means is that we need to improve access to abortion in our healthcare system.”