A growing cohort of doctors and researchers want medication abortions to be available at your local pharmacy.

Ten doctors, researchers, and legal experts wrote an editorial in "The New England Journal of Medicine" asking the Food and Drug Administration (FDA) to lessen restrictions on the drug used in medication abortions.

The FDA approved a medication abortion drug, also known Mifeprex, more than 16 years ago. Clinicians use the drug to induce miscarriages in pregnant women, rather than subjecting them to a surgical abortion.

The FDA approved Mifeprex in an effort to make abortion accessible to women earlier in the first trimester, when the procedure is safer and less controversial.

Fourteen years later, the Centers for Disease Control and Prevention reported that women were indeed getting abortions earlier into the first trimester. Officials now estimate nearly a quarter of all women seeking abortions use Mifeprex.

Based on the success of Mifeprex, the FDA updated the drug label last March.

Among other things, the FDA lowered the recommended dosage, decreased the number of visits a woman has to make to the doctor, and extended the period of time in which she can take the pill.

Abortion rights advocates cheered the FDA's decision at the time.

"This is a major shift both in closing the gap between science and legal regulation and in enabling women to exercise their constitutional right to terminate a pregnancy," Suzanne B. Goldberg, asexuality and gender law professor at Columbia University, told The New York Times.

This new group of experts, however, believes there's more to be done. They are asking the FDA to completely overhaul the way Mifeprex is distributed.

photo: iStock

"In merely updating the label, the FDA did not go far enough," the group, which calls themselves the Mifeprex REMS Study Group, wrote. "The distribution of Mifeprex remains substantially and unnecessarily encumbered by a Risk Evaluation and Mitigation Strategy (REMS), which was left fundamentally unchanged."

A REMS is essentially a safety plan that the FDA creates for certain drugs when they're first introduced to the market. When Mifeprex debuted, its REMS required it to "be ordered, prescribed, and dispensed" by healthcare providers who meet specific qualifications. Providers had to be able to provide surgical intervention and entry to the emergency room if needed.

But now — 16 years and one label-change later — the REMS for Mifeprex remains the same. And this group of experts isn't happy about it.

"[The REMS] is kind of a silent dampener on knowledge and use," Dr. Beverly Winikoff, a member of the group, told Revelist. "I think it's part of the whole underutilization or under-availability of the medicine."

Winikoff explained that private providers (like your regular doctor or OBGYN) must complete a special certification to be able to prescribe the drug. Plus, they either have to stock Mifeprex in their office or order it themselves. Patients aren't allowed to simply pick it up at the pharmacy.

In practice, this means most women who want medication abortions wind up getting them at an abortion clinic — somewhere many women, understandably, want to avoid. 

Winikoff and her colleagues claim Mifeprex is being subjected to a double standard.

photo: iStock

They point out that, out of the 3 million women who have used Mifeprex over the last 16 years, only 19 deaths have been reported. Other serious reactions, like major infections, occur in less than 1% of patients.

However, more than three people per every 100,000 die from overdosing on painkillers

"The point is, this is a really safe and effective drug," Winikoff said. "It's much safer than many drugs that are prescribed normally. Why is this drug being held hostage to some archaic system? That's really the question, and no one's bothered to ask it."

There are, however, a few serious reasons why no one is asking this question.

One is that Mifeprex may not be as safe as the Mifeprex REMS Study Group purports. The American College of Obstetricians and Gynecologists, which is largely supportive of medication abortion, still suggests some restrictions on who can provide the drug.

Their official guidance on first-trimester abortions advises that "clinicians who wish to provide medical abortion services either should be trained in surgical abortion or should be able to refer to a clinician trained in surgical abortion."

Another reason is that changing the REMS would be expensive. Abby Long, a spokesperson for the company that makes Mifeprex, said the company has already spent $1 million on revamping the label.

"For a small company such as ourselves, that makes only one drug, that's a fairly significant amout of money," Long told Revelist. She said she doesn't see her company pushing for the removal of the REMS anytime soon.

But WInikoff and her group believe they have a chance to ensure greater access to abortion for all women.

pro-choice protest
photo: iStock

"There's been this kind of inertia," Winikoff said of the REMS process. "The FDA was not unhappy with what was going on because they weren’t getting any problems. No one was creating a ruckus."

You can bet the Mifeprex REMS Study Group will be making that ruckus.