Over 16 years ago, the United States stood on the brink of a reproductive rights revolution. The FDA was in the final stretch of approving mifepristone, a drug already available in Europe in China, which was said to make ending a pregnancy within the first 10 weeks as easy as taking a pill. Reproductive health advocates stateside anticipated that this move would radically change the landscape of abortion access.
Even after the victory of Roe v. Wade, hospitals shied away from providing abortion services due to intense stigma and political maneuvering by anti-abortion activists. As a result, surgical abortion had been confined to some of the only spaces willing to help women: stand-alone reproductive health clinics, which were scarce, not to mention vulnerable targets for protesters. In the late 90s, the abortion pill was set to change that.
"If and when mifepristone does become available, it will remove many of the political and practical barriers that have made it difficult for US women to get abortions—and for many physicians to perform them," a Mother Jones article claimed in 1999. A survey of doctors earlier that year, the article went on to note, "found that 54 percent of all obstetricians and gynecologists, including 45 percent of those who don't currently perform abortions, said they would offer mifepristone if it were available."
Later-term surgical abortions would still be necessary for a lot of women, but mifepristone (in combination with an existing drug called misoprostol, which increases uterine contractions) was poised to bring abortion into the mainstream by widening the pool of providers willing to provide abortion services at all: They would be able to simply write a prescription for a pill.
With RU-486 termination of early pregnancy will be done medically, not surgically, under conditions that will make it largely impossible to stop.
Mifepristone was supposed to give women more control over their bodies, their families, and their health by expanding their choices and privacy. It was seen as the holy grail that would thwart abortion foes, who, as always, had been working hard to overturn Roe v. Wade and complicate abortion access: "With RU-486," as the pill was known at the time, "termination of early pregnancy will be done medically, not surgically, under conditions that will make it largely impossible to stop," a Chicago Tribune article from 1992 professed. Some advocates had hoped the abortion pill would be available directly through pharmacies and eventually over-the-counter, like Plan B.
Clearly, this hasn't been the case. Over a decade later, abortion access has hardly expanded beyond the clinic setting, and in states across the country, those clinics are being forced to shut down. As of 2014, the abortion pill accounted for 43 percent of abortions in the US; however, it's still not the easy-to-access alternative that reproductive health advocates thought would be possible over a decade ago. What happened?
The history of the abortion pill is fraught from the start. In 1980, a French pharmaceutical company, Roussel-Uclaf, developed the medication abortion drug, which works by blocking the effects of progesterone, a hormone essential to maintaining pregnancy. After a series of clinical trials in 1988, it was approved by the French Ministry of Solidarity, Health, and Social Welfare for distribution. The anti-abortion backlash within the country was swift. Anti-abortion protests and threats of boycotts for other products caused Roussel-Uclaf's parent company to halt the production of mifepristone out of fear that it would hurt their bottom line. Thankfully, just two days later, the French government intervened and ordered the company to resume production of the drug in the interest of public health, calling it "the moral property of women."
Here in the US, however, the intense anti-abortion political climate stopped Roussel-Uclaf from bringing the abortion pill to market, despite the efforts of feminist groups like the Feminist Majority Foundation. And under George Bush, the FDA banned importation of mifepristone—though that didn't stop women from trying to smuggle it in.
In 1993, all that changed: Although the Hyde Amendment still passed in Congress that year and the "Freedom of Choice Act," which would have codified abortion access into law, was defeated, the Clinton administration ushered in a new era of executive support for reproductive rights and requested that the FDA reconsider the importation ban. The following year, Roussel-Uclaf donated the rights to mifepristone to the Population Council, a New York-based nonprofit research institution, and they began US-based clinical trials on its safety and efficacy. By 1995, the Population Council had filed a FDA New Drug Application for mifepristone.
But the battle to get the abortion pill approved in the US would still take years. The anti-abortion lobby, along with Republican politicians, tried to delay it as long as possible; in 1996, the public hearings on the abortion bill got underway, and the proceedings essentially became a debate between women's health providers and abortion foes. Documents from the advisory committee for the drug's approval show a letter that discusses the purported "psychological effects" of the abortion pill and goes on to say that "the practice of birth control in any of its forms is an evil" was submitted for consideration alongside the preliminary results of the Population Council's year-long clinical trial, which showed that the abortion pill was safe to use, and that women favored the method.
The committee also heard testimony about the link between abortion and breast cancer, a widely used anti-abortion misinformation tactic. "However safe this drug regimen may appear in short term testing, there is too much hard evidence that, in the long term, many thousands of women will get breast cancer because they took these drugs," Dr. Joel Brind, one of the main religious advocates for the anti-abortion pseudoscience, told the committee. The National Cancer Institute, the American Cancer Society, and the American College of Obstetricians and Gynecologists (ACOG) have all conducted scientific reviews of the literature on the subject and concluded that there is no link between abortion and breast cancer.
...The political climate is really interfering in the science.
Simultaneously, congressional Republicans, who controlled the majority of both Houses, led by Speaker Newt Gingrich, attempted to stymie the process, though they were unsuccessful. Despite their opposition, the FDA advisory committee recommended mifepristone for approval and ultimately approved it in 2000, following the Population Council's long search for a willing manufacturer. In the years in between the first hearing about mifepristone and its eventual approval, states across the US were busily passing parental consent laws and working to make late-term abortion illegal.
But the abortion pill wasn't out of the clear yet. In June, the New York Times reported the agency was considering additional regulations. These included "restricting prescribing privileges to doctors who perform surgical abortions," which would largely defeat the hope of mifepristone expanding abortion access beyond dedicated clinics.
The medical affairs vice president for Planned Parenthood of America, Dr. Michael Burnhill, said at the time that the FDA was also proposing requirements that "prescribing doctors be trained in mifepristone's use, be trained in reading ultrasound scans, and maintain admitting privileges at hospitals with emergency facilities no more than an hour from their offices, in case women experience complications." The last of these requirements bears a striking similarity to some of the unnecessary, burdensome regulations passed in 2013 by the Texas government, which shut down the majority of abortion clinics in the state and were deemed unconstitutional last year.
''To encumber a drug like this is extremely unusual for the FDA,'' Dr. Wendy Chavkin, a professor of public health at Columbia University, told the New York Times. ''We have Viagra [which was patented in 1996 and approved in 1998] that went out in widespread fashion even though there was some suggestion that it might cause serious cardiovascular events. In contrast, [mifepristone] is a highly studied drug where the safety and efficacy have been demonstrated. That indicates how the political climate is really interfering in the science."
Indeed, anti-abortion activists insisted that mifepristone was dangerous, but the actual clinical trials suggested otherwise.
Negotiations between the FDA and the drug's manufacturer, Danco, concluded with regulations that were not quite as extreme. Still, the abortion pill still ended up being highly restricted: The FDA mandated that mifepristone fall under a set of added regulations known as a Risk Evaluation and Mitigation Strategy (REMS), which are typically only required for drugs that cause severe adverse effects. Only 74 of the approximately 1750 prescription drugs and ingredients approved by the FDA have REMS protocols. For the abortion pill, those requirements include mandating that prescribers become certified to distribute mifepristone, that patients are made to review an agreement of the potential risks, and that the drug can only be dispensed in clinics or medical offices—meaning that the prescribing health care provider cannot simply write a prescription for their patient to pick up in a pharmacy.
Over the past 16 years, we've seen that these rules haven't made the abortion pill safer for women—just harder to obtain. Some reproductive health advocates argue that these REMS protocols—like TRAP laws or "informed consent" brochures that require doctors to lie to their patients to discourage them from terminating their pregnancies—were based in politics, not research.
"When the mifepristone application was first submitted to the FDA, we had high hopes that this new form of abortion would greatly improve access for women, including taking it beyond the often controversial abortion clinic setting. Indeed, there were numerous family practice clinicians who were excited about expanding their services," Elisa Wells, the co-director of the Plan C campaign, which promotes information about the abortion pill, wrote in an email. "So, it was a huge disappointment when the FDA approval process for mifepristone was driven by politics not science. This resulted in medically unnecessary restrictions that have greatly reduced access and diminished the potential of this very safe and effective form of abortion."
To this day, the REMS protocols are in place, preventing true, unburdened access to the abortion pill. Coupled with harsh, anti-abortion state laws, this is devastating for women. The FDA recently modified the label for mifepristone to cut out the unnecessary additional clinic visit for the second dose of medication, allow it to be used longer into pregnancy, and to allow medical providers, like nurses, to administer the drug. But researchers and advocates say this doesn't go far enough.
In a paper recently published in the New England Journal of Medicine, researchers under the banner of the Mifeprex REMS Study Group (Mifeprex is the brand-name for mifepristone) have called for the REMS protocol to be removed. Noting that the rate of deaths associated with medication abortion is 0.00063 percent—which is 14 times less than the rate of women who die due to childbirth in the US—and that its side effects are "minor and transient," they write that the restrictions on the pill make no clinical sense.
"We now have huge amounts of clinical data [on mifepristone], and there's nothing exceptionally dangerous about it. Many other drugs have far greater risks," said Beverly Winikoff, one of the paper's authors. "And, in any case, there's also no specific way that the REMS mitigates these supposed risks."
Lifting the REMS protocols would make it easier for both providers and women, though it's uncertain if Danco, the pill's manufacturing company, will file to do so. (The REMS protocol also happens to give the company a monopoly on the drug.)
We now have huge amounts of clinical data [on mifepristone], and there's nothing exceptionally dangerous about it.
Currently, a provider must become certified to distribute the pill by completing and sending a form that says they can assess pregnancy duration, diagnose ectopic pregnancy, and provide surgical intervention if needed. Once they've done that, they have to make the decision to stock the pill in their office or clinic—and, if they decide not to, they have to order it on a case-by-case basis, meaning the patient has to wait for it to come in, delaying care.
Winikoff explained that she has spoken with individual providers, who have told her that this is a huge deterrent to offering the abortion pill in their practices. "There's really no objective reason why this drug should not be in pharmacies like every other medication," she said.
Even if some healthcare professionals refuse to write prescriptions for mifepristone, due to the stigma that still exists around abortion, removing the REMS protocols would allow for the drug to be prescribed by willing providers via telemedicine to a wide range of patients. This would greatly expand access to women who cannot get to a clinic or doctor's office, or who don't have any in their area. Widening access to the abortion pill would also reduce the rate of late-term abortions.
In the future, perhaps, if mifepristone goes the way of Plan B, women won't need to be in contact a health care provider at all. "It is high time the REMS requirements are removed to allow women the access they deserve to these pills," Wells told me. "In many other countries, women can buy these very same pills directly off a pharmacy shelf, which we hope will be the eventual level of access in the US."