It's Been 15 Years Since Mifepristone Was Approved: How The 'Abortion Pill' Has Impacted Reproductive Health Care
Fifteen years ago, on Sept. 28, 2000, the U.S. Food and Drug Administration (FDA) approved mifepristone — the abortion pill. Dr. Beverly Winikoff, president of Gynuity Health Projects, recalls that getting approval in the U.S. was an especially long, hard-fought battle.
“It took a full 12 years [after the pill was approved in Europe],” she said during a recent press call. “It took quite a bit of maneuvering and advocacy, as well as reorganizing for innovative pharmacy development to get the drug…probably because of the unusual circumstance and of the topic. Regulatory approval was unusual, and the drug was subject to quite a restrictive regimen and restrictive distribution.”
Back in 2002, the Guttmacher Institute reported that the FDA’s approval held out certain hopes for women, including the possibility of completing an abortion in the privacy of their own home, as well as the possibility of new providers providing abortion services for the first time. The latter was believed, theoretically, to “not only increase women's geographical access to abortion, but also to reduce the violence directed toward abortion clinics and, ultimately, defuse the abortion debate,” the GI said.
Today, after 15 years of experience, many of these hopes seem to have become a reality. Winikoff said that 2.5 million women have had a medical abortion, a two-pill regimen that has proven to be “very effective, very safe, without any need for special precautions and very acceptable to many American women.” The available data on mifepristone is courtesy of the FDA, various clinics, and the drug’s own distributor, “so the data is quite good,” she added.
Winikoff mentioned, too, that medical abortions do not seem to increase the overall rate of abortion — not in the U.S. or any place else this pill has been introduced. This was a chief concern among anti-abortion activists at the time of the approval, that mifepristone would only make abortion "more convenient for abortionists” and "too easy" for women to obtain, thus the increased rate, the GI found.
But Winikoff and Dr. Dan Grossman, the vice president of research at Ibis Reproductive Health, both feel that scientific advancements and provisions in place for medical abortion have actually reduced the abortion rate.
More Than a Pill
If medical abortion has done anything for women's health it's improve access to quality care, especially in rural communities. From a scientific perspective, pharmacists have figured out how to lower the dose of mifepristone, which in turn lowers the total cost of the drug. And telemedicine is an example of a helpful provision in place for women seeking medical abortion; it allows women to text or video chat doctors and physicians in other cities in the event they don't have adequate resources to medical professionals within their community.
Grossman referenced research that has shown the telemedicine provision of medical abortion is safe and effective, and associated with improved access to early abortion. In Iowa, where the provision was introduced in 2008, there's been a reduction in second trimester abortions, he said. So at a glance, not only has medical abortion provided a non-invasive alternative to surgical abortion, but it's also made abortion more affordable and accesible to some women.
That said, the fight for medical abortion continues.
“In about 18 states telemedicine provision is banned, and in three states, women are denied access to medical advancements regarding the way medical abortion is provided, including a lower, more cost-effective dose," Grossman said. "The craziest restriction of them all is that in 3 states, facilities providing medical abortion must meet the standardss of ambulatory surgical centers, so they’re essentially like mini hospitals. Women have to be in an operating room to take this pill, which really doesn’t make any sense. It only serves to restrict access to medical abortion."
Restricted access to abortion may be most prominent in Texas, where provisions set by anti-abortion bills HP15 and HP2 enforce "outdated protocol" and "unnecessary regulations."
“In my 15 years of providing comprehensive reproductive health care, I’ve really seen the good, the bad, and the ugly,” said Andrea Ferrigno, the corporate vice president of Whole Woman’s Health. “I’ve seen how mifepristone and medical abortion can benefit women’s lives, and I’ve also seen the impact medically unnecessary restrictions [passed by] politicians can have on families and communities.”
Abortion restrictions, including those on telemedicine, not only interfere with Ferrigno’s ability to provide her patients with the best possible care, but it also prevents other medical professionals and advocates from truly maximizing “this revolutionary drug.”
Running Interference
Medical abortion and telemedicine make it so physicians can continue advising women no matter what — in Texas, this could mean assisting women despite power outages caused by a tropical storm. In fact, Ferrigno recalled one scenario in which patients were “nothing but grateful” to a physician that was able to conduct appointments from home after storm debris made it impossible to travel into the office.
“Recently, these success stories have been few and far between,” Ferrigno said.
She points a finger at HB15, which requires patients to meet face-to-face with the physician that will administer the medical abortion 24 hours before she plans to take the pill. And in 2013, HB2 prohibited women (among other things) from receiving mifepristone from anyone other than a physician — nurse practitioners and midwives can not aid women, even though they've been found to successfully adminster mifepristone. HB2 also requires women be no more than 7 weeks pregnant when obtaining the pill, go through a 3-day obtaining process, and then make a fourth trip to the clinic for a follow-up visit.
“This ties our hands and prevents us from providing services on the individual level patients deserve,” Ferrigno said. “It prevents us from following evidence-based procedures and using telemedicine, all the while forcing women to travel hundreds of miles to take a pill that they can just as easily, just as safely take at home.”
Ferrigno still thinks of one woman seeking a medical abortion just after HP2 was passed. She was a victim of assault, six-and-a-half weeks pregnant, and lacked the resources to comply with Texas’ regulations before reaching her seventh week of pregnancy.
“Medical abortion offered this woman a way to terminate this pregnancy in a non-invasive way that would help here here emotionally, but instead she would have to travel or be subjected to a [surgical] procedure she didn’t want," Ferrigno recalled. "In the end, she did not have the resoures to access the care she could have right in her community."
That said, medical abortion isn't like the Advil you take for headache; the GI reported some women experience heavy bleeding and gastrointestinal symptoms, like cramping and nausea. Rather, mifepristone has simply proven to be a safe and effective alternative to surgical abortion. For women in areas where health care is considerably more restricted, like Texas, the telemedicine that often goes hand-in-hand with medical abortion helps them save on costs related to both care and travel. Women should still talk with their providers about what options will best serve them.
"Most of the predictions we heard 15 years ago were either too alarmist about what the intro of this medicine might do, or too euphoric in terms of how it change the way women experience abortion," Winikoff said. "Nonetheless, we've really changed the base of what it means for women to get an abortion."