A first-of-its-kind study underway in California and Washington state could pave the way for the Food and Drug Administration to make mifepristone, the most widely used abortion drug in the United States, available at pharmacies.
Today, mifepristone is only available at abortion clinics, doctor’s offices or hospitals, from providers who register with the drug’s manufacturer. The FDA imposes special rules on mifepristone that prevent it — unlike most medications — from being stocked and sold in a pharmacy.
Researchers behind the new study believe those restrictions are purely political and not grounded in any evidence. And they have set out to find whether patients who obtain mifepristone in a pharmacy, like any other drug, experience any drawbacks.
Under President Donald Trump, the odds of easing the restrictions on mifepristone are essentially zero. Scott Gottlieb, Trump’s first appointment to head the FDA, was an opponent of expanding reproductive care. Gottlieb stepped down this spring, and most expect his successor to take similar positions.
Still, there is precedent for lifting restrictions on mifepristone when a large enough body of research shows the restrictions aren’t medically necessary. In 2016, the FDA under President Barack Obama followed such evidence, and expanded the window during which the drug can be prescribed from seven weeks into a pregnancy to 10 weeks. It also reduced the recommended dosage. The changes more than doubled the percentage of abortions eligible to be performed by medication and drastically reduced the overall cost associated with the procedure.
“In terms of access to medication abortion, this could be a big deal,” said Sally Rafie, a pharmacist specialist at UC San Diego Health who is helping conduct the study. “A lot of health care providers who would like to provide the service currently are not because they don’t want to deal with playing the role of the pharmacy.”
The study is taking place in six locations in California and Washington, all of them universities or large hospital campuses with on-site pharmacies.
Researchers are enrolling patients for the study who have already elected to have a medication abortion. They aim to recruit a total of 250 patients, and about half that many patients have already gone through the study. Patients are asked about their experience at a follow-up appointment to evaluate their safety and comfort levels.
The patients undergo the same screening and counseling as other abortion patients seen by the participating health care providers. The only difference is, when it came time to hand the patients the mifepristone, they went to an on-site pharmacy. The pharmacies all have FDA permission to stock the drug for the limited purposes of the study.
“It really does seem like the dispensing restriction is a real barrier to access,” said Daniel Grossman, director of Advancing New Standards in Reproductive Health, a University of California research group, who is also overseeing the study. “And if it were removed, it would greatly improve access to early abortion.”
The FDA typically reserves these types of restrictions, known as a risk evaluation and mitigation strategy, for drugs that are hard to administer or that carry a high safety risk. Clozapine, a schizophrenia drug, for instance, can devastate a user’s white blood cell count, and so prescribers are required to carefully monitor patients’ levels. With mifepristone, though, serious side effects are rare, and its safety record resembles those of other drugs the FDA doesn’t regulate as tightly.
Reproductive rights advocates have long argued that the restrictions on mifepristone exist purely due to the stigma surrounding abortion, and major medical groups such as the American Medical Association have called on the FDA to drop them.
Even with the restrictions in place, millions of people seeking an abortion have opted for mifepristone over a surgical procedure. The drug, which can be used in the first 10 weeks of pregnancy, is highly effective and has a safety record comparable to surgical abortion, but it does not involve an invasive procedure.
“It suits people who prefer the privacy it affords,” said Rachel Jones, a research scientist at the Guttmacher Institute, a think tank supportive of abortion rights. From 2001, the year after mifepristone became available in the United States, to 2014, the share of abortions that are medication-induced shot up from 6% to 31%, a Guttmacher analysis found.
Some believe lifting the FDA restrictions has the potential to make the drug vastly more accessible. Guttmacher data shows that mifepristone is already available in most abortion clinics. But it is prescribed by very few general practice OB-GYNs and family medicine doctors, many of whom don’t want to bother with the costs or regulations associated with playing the role of a pharmacist.
If they could simply write a prescription for mifepristone without having to stock it, 28% of OB-GYNs who don’t currently provide medications say they would, according to a survey that Grossman and his team published in March. (Pharmacies are already allowed to carry misoprostol, a drug that is typically prescribed alongside mifepristone.) Removing the restrictions would also affect patients who are prescribed mifepristone for its other use, helping to safely pass a miscarriage.
Erasing the restrictions might even make it possible for online pharmacies to sell mifepristone. Today, websites that try to retail the medication in the U.S. are targets of an FDA crackdown.
“That would be a game-changer,” Jones said.
Not A Dangerous Drug
The study is taking place against the backdrop of a bigger fight over how easily patients should be able to access abortion-inducing drugs.
For someone who wants an abortion, taking pills is often simpler than scheduling a procedure. Many conservative legislatures have therefore passed laws, like requirement for in-person counseling and dispensing, that make it more difficult.
When told of the new study, Steven Aden, general counsel for the group Americans United for Life, which helped write many of those constraints, said lifting the restrictions on mifepristone could pose a danger to patients.
The FDA “imposed the special conditions on its use for very strong reasons that continue to apply today,” Aden wrote in an email. “Chief among these was the recognition that patients should be counseled in its use by a licensed clinician who can advise them of the real risks and dangers in using it, including the small but ever-present risk of a dangerous ectopic pregnancy and the threat to her health if she does not have nearby access to a hospital emergency department for a surgical abortion in the event that a completed abortion does not occur ― as happens in a significant number of cases.”
In fact, while 2% to 4% of patients who take abortion drugs don’t have a complete abortion, that does not usually constitute an emergency; those patients can take more medication or schedule a surgical abortion. Serious side effects are rare. A recent study of more than 11,000 women who used the drug found that .03% of patients had serious bleeding requiring a transfusion and .01% required hospitalization.
In terms of access to medication abortion, this could be a big deal. Dr. Sally Rafie, pharmacist specialist, UC San Diego
The researchers in this study are not proposing to make mifepristone available without the involvement of a medical professional who screens the patient for risks like ectopic pregnancies and discusses the medication’s potential side effects. And offering mifepristone in a pharmacy rather than a clinic wouldn’t change where the actual abortion occurs: at home, many hours after a patient takes the medication.
Other states have gone in the opposite direction, placing few or no additional restrictions on abortion medication and even making it possible to provide the drug by telemedicine ― the patient and provider have their appointment over video, and the provider remotely opens a drawer at the patient’s location, like a cash register, that contains the pill.
Meanwhile, reporting and studies suggest that some patients who want an abortion are simply buying the drugs online, without a prescription, from overseas pharmacies.
Researchers have tested the potential to screen and prescribe the drug to patients remotely and then send the mifepristone by mail, so that the patient doesn’t even need to visit a telemedicine clinic. California and Washington, where this new study is taking place, were two of the first states to allow pharmacists to prescribe birth control.
The pharmacy model this new study is testing is already at work in other countries. In Canada, where mifepristone first went on sale in 2017, advocates persuaded the national health agency to allow pharmacies carry the drug and lift a requirement that pharmacists get special training.
“Since then, we’ve seen a huge change in access and the makeup of what the public is asking for,” said Frederique Chabot, director of health promotion for Action Canada for Sexual Health and Rights, one of the advocacy groups that worked with the government. Prescriptions for the drug surged in British Columbia, Canada’s vast western province, and on Prince Edward Island, a far-flung province where patients are allowed to receive mifepristone by courier.
About 4,200 Canadian patients got mifepristone prescriptions at a regular pharmacy the first year the drug was available, according to figures put out by the Canadian government.
Jones said that lifting the U.S. restriction on pharmacies wouldn’t change access overnight.
“It’s not going to become reality that all of a sudden, every pharmacy is going to stock it,” Jones said. “It doesn’t mean, even in a place like New York City, every Duane Reade is going to start stocking mifepristone. It might be too stigmatized for the national chains.”
In Canada, Chabot noted, advocates are having to work to ensure that when a physician prescribes mifepristone, there’s a pharmacy nearby that’s willing to stock it.
Still, the researchers said, asking whether stocking mifepristone in a pharmacy is even possible is a critical first step.
“This is about patients being able to take care of themselves, and how this is not a dangerous drug,” said Rafie, the UC San Diego researcher. “We shouldn’t be treating it as such.”