FDA Expands Access to Abortion Pills — But What Will the Impact Be?

On January 3, the Food and Drug Administration (FDA) announced that mifepristone, one of the two drugs used in medication abortion, can be dispensed directly to patients in pharmacies, including chains, and through mail-order pharmacies with a prescription. Previously, abortion medication was only available through an in-person visit to a doctor’s office, hospital, or health clinic.

Medication abortions make up more than half of all abortions, and advocates hailed the decision. “It is a really big shift in how mifepristone has been dispensed,” said Amy Williams Navarro, senior manager of legislative affairs at NARAL Pro-Choice America. “Before, people had to go in person to their health care provider and now people have the flexibility for a telehealth visit and can access the drug at their local pharmacy or through the mail. Even in states where abortion is legal, there are still barriers with lack of clinics, etc., and this just hugely increases access. And if people are traveling across state lines, they can go to a local pharmacy like a CVS or a Walgreens instead of having to go to an abortion clinic, although they still need a prescription.”

Some advocates remain cautious about how transformative this will be. “The FDA rule certainly has the potential to expand the availability of medication abortion,” said Odile Schalit, executive director of the Brigid Alliance, which provides support for people who have to travel to get an abortion. “However, state laws regulating telehealth, abortion, and dispensing of medication abortion in person could unfortunately blunt the impact of the FDA ruling and keep people in politically hostile states from accessing medication abortion.”

Despite the potential for increased availability of medication abortion, “doctors still cannot prescribe abortion pills to women in the banned states,” said Dr. Suzanne Poppema, an expert in medication abortion and a consultant to Aid Access, an international abortion provider that distributes abortion pills through the mail to all 50 states. Their workload has quadrupled since the Supreme Court Dobbsdecision in late June overturning Roe v. Wade. “States where abortion is legal need to create shield laws to protect doctors everywhere. But getting legislation passed is a very lengthy process.” Several states have protections for abortion providers as well as patients, but only Massachusetts has one that covers telemedicine. New York could become the second state: On January 24, the state Senate passed a shield law that includes telemedicine, and that bill is now before the state Assembly.

In December 2021, because the COVID-19 pandemic prevented many in-person health visits, the FDA temporarily lifted the requirement that mifepristone can be dispensed only in person. Although the agency has now made that change permanent, the FDA requires that pharmacies be specifically certified to dispense mifepristone, which isn’t the case for thousands of other medications. It has also kept other requirements that it doesn’t apply to other drugs, which only creates more steps and therefore more hurdles to obtaining medication abortion. These include a requirement that the prescriber be specifically certified and that patients and prescribers sign a patient agreement form. “Because administrative barriers, such as requirements that physicians be certified and that the pharmacy become certified, will hinder which pharmacies and mail-order companies will stock the pill, we continue to face some of the same obstacles to abortion care,” said Sylvia Ghazarian, executive director of the Women’s Reproductive Rights Assistance Project, an abortion and emergency contraception fund that works directly with providers on behalf of patients. “It is concerning that mandates have been set by the FDA even though the abortion pill is safer than other medications such as Tylenol and Viagra.”

Advocates have been critical of the FDA’s strict protocols — called Risk Evaluation and Mitigation Strategy (REMS) — for mifepristone, which was first approved for use in 2000. From the beginning, the FDA required in-person dispensing at a hospital, clinic, or medical office. “For decades, scientific evidence has affirmed what we know to be true: abortion pills are safe and effective,” said Melissa Fowler, chief program officer at the National Abortion Federation, the professional association of abortion providers. “Yet in many cases, access to this care remains curbed by outdated hurdles that have no basis in medicine.”

These obstacles have had a ripple effect. “When abortion pills first became available in the U.S., I thought it had the potential to increase the number of doctors that provided abortions,” said Poppema. “But that didn’t happen because of the REMS.”

Although the new FDA rules don’t remove all the barriers, it is a significant move toward having medication abortion available without a prescription. “It is an important step, and that’s how change happens — not in leaps and bounds but in steps,” said Elizabeth Nash, state policy analyst at the Guttmacher Institute. “Allowing pharmacies to dispense medication abortion gets us closer to it being seen as part of regular health care. The problem is that abortion is illegal in a quarter of the states, and so we are seeing a conflict between federal laws and states’ laws. In banned states, people still need to travel or get the medication online. One issue is that you leave a digital footprint, and we are seeing some indication that abortion opponents will try to make it harder for people to self-manage abortions.”

Although CVS and Walgreens have made commitments to dispense mifepristone, “we are concerned about access in marginalized communities and also the growing concerns with states that ban abortion,” said Ghazarian. “How will pharmacies handle the administrative challenges? How many will not participate because of pressure and/or protests from customers who don’t support abortion? What about communities that have only one or two pharmacies nearby? In addition, we have already seen cases of religious and moral refusals from pharmacies for birth control.”

The certification requirements and additional paperwork “add a layer of complexity for pharmacies, providers, and patients,” said Dr. Ushma Upadhyay, a professor and public health social scientist at the University of California, San Francisco (UCSF) and also with Advancing New Standards in Reproductive Health, a research program at UCSF focused on abortion and reproductive health. “We know from research that when people have decided they want an abortion, they want it as soon as possible, and this can slow things down. When people see all these certifications it also adds a level of uncertainty, and there is no evidence that they are necessary.”

The American College of Obstetricians and Gynecologists requested that the FDA allow mifepristone to also be used for miscarriage management, but “they refused,” said Upadhyay. If it had been approved for miscarriage, Upadhyay points out, “that could have meant that pharmacies in banned states might have been more willing to carry mifepristone.”

The move by the FDA came about “through a wide range of advocacy work,” said Williams Navarro. “Some advocates were vocal and outspoken, some worked with the FDA on research, and some worked with the drug manufacturers who have been a key part of increasing availability. All changes to increase access help vulnerable communities the most, so it’s imperative that we continue to fight for access.”

For more information on obtaining abortion, see this resource list from Shout Your Abortion, an advocacy organization:

https://shoutyourabortion.com/resources/#abortion-pills-at-home-abortion