Why Aren't More U.S. Doctors Providing The 'Abortion Pill' To Their Patients? When the Food and Drug Administration approved Mifeprex 16 years ago, advocates assumed that the so-called abortion pill would improve U.S. women's access to pregnancy termination.
The thought was that doctors-mainly obstetrician/gynecologists and family practitioners-who didn't perform surgical abortions (also known as suction aspiration abortions) would add medication abortions with Mifeprex, the brand name for mifepristone, to the services they offered.
When the Food and Drug Administration approved Mifeprex back in 2000, 87% of counties had no abortion clinic, according to the Guttmacher Institute, a research and policy organization that focuses on sexual and reproductive health and rights. These counties weren't only in sparsely populated regions-nearly a third of U.S. metropolitan areas lacked an abortion provider in 2000, according to Guttmacher.
"The hope of Mifeprex was that it would move abortion out of clinics...and move it into private practice," Rachel Jones, principal researcher for Guttmacher's U.S. abortion studies, told me. "Unfortunately, it hasn't fulfilled that promise."
In the 16 years Mifeprex has been on the market, 2.75 million U.S. women have used it, according to Danco Laboratories, which distributes Mifeprex, sometimes referred to as RU 486. Due to regulatory roadblocks and the stigma around abortion, though, few doctors who don't also offer surgical abortion provide the drug, which blocks the hormone progesterone, needed for a pregnancy to continue. One or two days after taking a Mifeprex tablet, women take another drug, misoprostol, which completes the abortion at home.
In 2011, Mifeprex represented 23% of the 1.06 million abortions performed in the United States, Jones and Guttmacher colleague Jenna Jermain reported in 2014. The Guttmacher researchers are in the middle of analyzing 2014 abortion data, so, Jones said, she could not yet discuss the findings.
However, she and the other people I interviewed for this story questioned a news report this week that suggested medication abortions now represent about half of all U.S. abortions. Although the percentage of U.S. abortions performed with Mifeprex has increased over the years (while the total number of abortions has declined), it is still far from half, Jones said.
"Not many physicians want to take it on," Dr. Dan Grossman, a professor of obstetrics and gynecology at the University of California, San Francisco, explained. "One of the main barriers is doctors can't just write a prescription."
That's because the FDA requires a Risk Evaluation and Mitigation Strategy, or REMS, for Mifeprex. "Essentially, a REMS is a safety strategy to manage a known or potential serious risk associated with a medicine and to enable patients to have continued access to such medicines by managing their safe use," according to the agency.
Yet, Grossman told me, other medications, such as Viagra, have more worrisome safety records than Mifeprex, but they don't have a REMS. He's not advocating a REMS for Viagra, but he is questioning the need for one for Mifeprex. "It's quite clear that this is a very safe medication."
The Mifeprex REMS prohibits healthcare providers from writing a prescription that women could fill at a drugstore. Instead, according to the document, "Mifeprex must be dispensed to patients only in certain healthcare settings, specifically clinics, medical offices and hospitals by or under the supervision of a certified prescriber." The REMS does not specify that prescribers must be physicians, but 37 states prohibit any other type of healthcare provider, such as a nurse practitioner, from performing a medication abortion, according to Guttmacher.
Healthcare providers who want to perform abortions with Mifeprex must be specially certified, according to the REMS. To become certified, they must meet certain criteria, including the ability to accurately assess the duration of a pregnancy and diagnose ectopic pregnancies. They must also be able to perform surgery in case of an incomplete abortion or severe bleeding or have made plans for others to provide such care.
In a recent opinion piece in U.S. News & World Report, Grossman argued that the REMS is no longer necessary. He cited a study he had coauthored that analyzed California Medicaid data about emergency department visits and complications after nearly 55,000 abortions. Of the more than 11,000 that had been medication abortions, less than one-third of 1% of patients had a complication requiring hospital care, the study found. And, Grossman wrote, Danco has received reports of only 14 deaths linked to Mifeprex. Meanwhile, he wrote, more than 2,000 men have died while using erectile dysfunction drugs such as Viagra. "The REMS is completely not evidence-based," Dr. Linda Prine, a professor of family and community medicine at the Icahn School of Medicine at Mount Sinai in New York City, told me. "If you're a busy clinician, you have to be really committed to take all the extra time to jump through all these hoops."
In March, the FDA did update the REMS and other labeling information, based on the latest research, for Mifeprex, but it did not eliminate the REMS as Danco had hoped. "After reviewing the supplemental application, the agency determined that a REMS continues to be necessary to ensure the safe use of Mifeprex," according to a statement on the FDA's website. Whether Danco will pursue eliminating the REMS remains to be seen, said Abigail Long, director of marketing and public affairs. Long noted that the expense of doing so is particularly burdensome to a small company such as hers that sells only one product.
The labeling update included extending the time period during which the drug could be used from 49 to 70 days' gestation and reducing the dose needed from three tablets to one. Adding those three extra weeks doubled the percentage of abortion patients eligible for Mifeprex, from 37% to 75%, Jones and Guttmacher's Heather Boonstra wrote in June on the Health Affairs blog.
In addition, the new label dropped the requirement that women return to their doctor's office or clinic to receive misoprostol. Instead, they can take the medicine at home. The new label also says followup evaluations don't have to take place in person, which means women can call their healthcare provider instead of making another trip to the office or clinic.
Doctors' reluctance to provide medication abortions goes beyond the hassle of the REMS requirements, though.
"I think some of it also comes down to the fact that there is so much stigma around abortion," Long said. "I think the power of that stigma cannot be underscored enough in terms of the impact it has had on being able to access abortion care. It's easy to say that the REMS is a big part of it, but I don't think it's the only piece."
She said Danco representatives regularly encounter physicians who say they don't have a problem with abortion, "but I just send my patients to Planned Parenthood." Other say they don't have a problem with abortions but they have a partner who does, Long said. "It's kind of a comfortable way of saying, 'I don't want to do this.'"
Sometimes, Prine said, the lease for a doctor's office or health center might prohibit abortions in the facility.
In addition, Prine said, family practice doctors might not want to offer medication abortions because their malpractice insurance premiums will rise (ob/gyns already pay higher premiums, even if they don't perform abortions). "It's not based on actuarial evidence," Prine said. "There's no evidence that women sue a lot over abortion."
To Prine, medication abortions are an integral part of family practice medicine and enable women to avoid the protesters and stigma they might encounter by going to an abortion clinic.
"You can sit in the waiting room and nobody knows why you're there. You're just going to be taken care of in the most normal of ways," she said. "In a perfect world, women would get their abortions from their family doctor, just like they would get their Pap smears and their flu shots."