Do the FDA's new rules expand abortion pill access for people at the margins?

In early January, the Food and Drug Administration (FDA) finalized its decision to alter restrictions on dispensing abortion pills. Most notably, it allows some retail pharmacies to dispense the medication directly to patients. Previously, medication abortion was only available at clinics, directly from doctors, or by mail. The move comes amid the Biden administration’s efforts to strengthen abortion care protections after the Supreme Court’s ruling last year that overturned Roe v. Wade.

On its face, the FDA’s decision would potentially allow some pregnant people to access abortion medication through their local pharmacy. But a deeper look at the agency’s regulatory change reveals it would do little to broaden abortion access nationwide, particularly for low-income people of color. 

Reproductive health, rights, and justice advocates expressed mixed feelings following the FDA’s announcement. Lupe M. Rodríguez, who serves as executive director at the National Latina Institute for Reproductive Justice, acknowledged more work needed to be done to expand abortion access nationwide. Still, she took the new rules as a win. 

“We just really believe that movement forward is important. Celebrating small victories, I think that’s a big part of it,” said Rodríguez, whose organization works with advocates on policies to expand reproductive justice for Latinx communities. “And knowing that…the opening of conversation around these things will only make it easier for folks to get the care they need.”

Mifepristone, a medication used to safely induce abortions and known simply as the abortion pill, was first approved by the FDA over two decades ago. The drug is typically the first pill used in the two-drug regimen for medication abortions, followed by misoprostol that is taken roughly 24 to 48 hours later. Often referred to as self-managed abortion, abortion pills allow patients to terminate pregnancies safely and independently at home.

In 2011, the FDA imposed a set of restrictions on mifepristone through a Risk Evaluation and Mitigation Strategy (REMS), which previously allowed only a limited pool of certified providers to prescribe and dispense abortion pills directly to patients. Abortion experts criticized these restrictions because they significantly reduced access to medication abortion. There is a large body of research showing the drug’s safety and efficacy in inducing self-managed abortions. By the FDA’s own account, nearly 4 million women in the U.S. have safely used mifepristone to terminate their pregnancy since the drug was approved more than 20 years ago.

“Is it good that they’re putting it in pharmacies? Absolutely,” said Renee Bracey Sherman, who serves as executive director of We Testify, an organization dedicated to uplifting people who publicly share their abortion stories. “But the thing that we have been asking [the FDA] to do is remove the REMS restriction altogether.”

In addition to allowing chain pharmacies like Walgreens and CVS to get certified and dispense mifepristone directly to patients, the FDA’s adjusted rules allow abortion pills to be dispensed to patients by mail instead of in person. However, many of the legal limitations under REMS remain. For example, the medication prescriber must obtain a patient agreement form from the patient before dispensing mifepristone, and the dispensing individual must either be a certified clinician or a certified pharmacist.

“There are 14 things that the pharmacies that dispense mifepristone have to do that they don’t have to do for other medications, medications that aren’t as safe as mifepristone,” said Bracey Sherman, referring to the certification requirements for pharmacies under the new rule. 

She also added that mifepristone “is one of the safest medications on the market. It’s safer than Tylenol.”

After the fall of federal abortion protections last year, right-wing anti-abortion activists began targeting access to abortion medication on the state level. Based on data from the Guttmacher Institute, a research organization that focuses on reproductive rights, legislators introduced 118 medication abortion restrictions in 2022 across 22 states. Restrictions on abortion medication in many Republican-led states are even more restrictive than the FDA’s REMS require. 

Despite the recent tweaks to the FDA’s restrictions, advocates point out a glaring truth: the changes make virtually no difference in states where abortion is banned. 

“I’m happy that a lot of folks are talking about abortion, and that’s a really great way to destigmatize everything,” said Jonnette Paddy, the abortion fund director at Indigenous Women Rising (IWR), the only nonprofit advocacy group and abortion fund in the country specifically supporting Indigenous people accessing abortion. “But I don’t really expect to see any major differences with this announcement from the FDA. It’s still not great for folks who don’t have insurance, not great for folks who are in ban states.”

Indigenous people have historically faced difficulties in accessing healthcare services, including abortion care. Tribal communities primarily receive healthcare through the Indian Health Services (IHS), which is operated and funded by the federal government. That means Native people are unable to seek abortion care through IHS due to the Hyde Amendment, which bars the use of federal Medicaid funds for most abortions. Tribal lands have also long been medical deserts, and clinics that exist on reservations often lack obstetrics and gynecology services. 

According to Paddy, IWR’s activities have shifted since the Supreme Court’s decision in June. 

“We are becoming more of travel agents for our [Native] clients,” said Paddy, who is a member of the Navajo Nation. “There’s sometimes bans that go into play in some states pretty last minute, and so…we’ve had to scramble with clients trying to find them an appointment in a nearby state, trying to get their travel handled, getting the funds sent to them.” The abortion fund’s director also mentioned that IWR’s clients mostly come from Oklahoma, Arizona, New Mexico, and North Dakota, but over the last year they have received assistance requests from as far away as Alaska. 

Obtaining abortion care has been a longtime struggle for many communities of color, including Latinx folks, said the Latina Institute’s executive director. The organization’s research found approximately 6.5 million Latinx people are affected by state abortion bans, making them the largest group of women of color impacted by the bans. 

According to Rodríguez, even individuals who can legally obtain abortion medication struggle to secure the drugs because the pills can be just as inaccessible as procedural abortion. 

“We know that not everyone has equal access due to a lack of technology or connectivity. And that has definitely been the case for our community,” said Rodríguez, referring to abortion pills available through telehealth services. Other challenges include lack of transportation to attend a doctor’s appointment, inability to take time off work, language barriers, and immigration status. 

“For community members who are undocumented, the fear of deportation has caused many to not seek medical care in general,” she said. “We know that [for] so many community members in states like Texas that have banned abortion, movement out of the state is almost impossible” due to a lack of legal identification.

Beyond abolishing burdensome restrictions on abortion medication, another key element to truly broadening abortion access for all is fighting disinformation about abortion and keeping criminalization out of it, Bracey Sherman said.

“Black and brown people should not face criminal punishments because they’re trying to access safe medical procedures. People should not be arrested for making sure people have access to safe care,” she said. “I think that’s really, really critical.”

Natasha Ishak is a New York City-based journalist who covers politics, public policy, and social justice issues. Her work has been published by VICE, Fortune, Mic, The Nation, and Harvard's Nieman Lab...