WASHINGTON — For years, the only way doctors like family physician Dr. Graham Chelius could offer their patients abortion pills was by giving them the medication in their offices, a restriction put in place by the Food and Drug Administration. Chelius wasn’t able to stock the pills in his office on the Hawaiian island of Kauai, so he wasn’t able to provide medication abortions for his patients. This meant they had to travel to the nearest abortion provider on the neighboring island of Oahu.

“I have seen the anxiety and confusion in my patients’ eyes when I tell them that they have to fly to Oahu to obtain an abortion,” Chelius wrote in a court declaration. “I have heard them describe their frustration, anger and heartbreak.”

As the lead plaintiff in a lawsuit by the American Civil Liberties Union, Chelius argued for a simple solution: letting patients pick up the pills at pharmacies.

The lawsuit, which was filed in the U.S. District Court of Hawaii in 2017, challenged the constitutionality of the FDA’s in-person dispensing requirement for abortion pills. While the case is still ongoing, the FDA decided in January to start allowing brick-and-mortar pharmacies to provide abortion pills with a doctor’s prescription.

This breakthrough makes it much easier for doctors like Chelius to offer medication abortions to their patients, physicians and abortion rights advocates say.

But a federal lawsuit out of Texas threatens to derail this expansion of abortion access. A coalition of conservative groups is challenging the FDA’s decades-old approval of the abortion pill. In April, a conservative judge ruled to suspend the FDA’s approval of the medication, but the Supreme Court has blocked this ruling while the case is appealed.

Meanwhile, the focus of the Chelius lawsuit will pivot to challenging remaining FDA restrictions on abortion pills, Julia Kaye, the lead ACLU attorney on the case, told Medill News Service in January.

The Chelius case is not the only lawsuit challenging the remaining restrictions. A coalition of attorneys general in 17 states and the District of Columbia filed a separate case in February challenging the FDA’s restrictions on the abortion pill. The same day that the Texas judge ruled to suspend the medication’s approval, the judge on that case issued a conflicting ruling ordering that it be kept available in those 17 states and D.C.

Abortion clinics in three states filed their own lawsuit in May also challenging the FDA’s restrictions.

The FDA approved the drug mifepristone for use in early pregnancy termination in 2000. It is the first of two drugs taken to terminate pregnancies up to 10 weeks. The FDA regulates mifepristone under a Risk Evaluation and Mitigation Strategy (REMS), which adds restrictions on a medication because of serious safety risks.

The regulations on mifepristone used to include that prescribers had to directly dispense the drug to patients, but this was temporarily lifted during the COVID-19 pandemic. The FDA began allowing patients to receive abortion pills through the mail, either from the prescribing clinician or from an online pharmacy, after a telehealth appointment.

In 2021, after conducting a review of the mifepristone regulations, the FDA decided to permanently remove the in-person dispensing requirement. On Jan. 3 of this year, the FDA approved a modified version of the regulations that removed the requirement and allowed both online and brick-and-mortar pharmacies to dispense mifepristone.

The second drug in the two-drug regimen, misoprostol, is not subject to added FDA restrictions and was already available at pharmacies.

In a declaration to the court last year, Chelius said the in-person dispensing requirement prevented him from prescribing abortion pills for his patients, as stocking and dispensing mifepristone would require the cooperation of colleagues opposed to abortion.

“In order to comply with the (FDA’s requirement) that I procure, stock and dispense (mifepristone) at my medical facility, I would have to risk serious damage to my professional standing in my workplace and to my respected role in the local community,” Chelius wrote.

For many primary care doctors, the in-person dispensing requirement acted as a barrier to them prescribing abortion pills to their patients, as they often lacked the necessary infrastructure to stock the medication.

A study published last year by researchers at the University of California San Francisco found that out of 56 family physicians interviewed, 23 described the in-person dispensing requirement as a barrier to providing abortions because of difficulties stocking abortion pills.

“This is not something that many clinicians are easily able to do,” Kaye said. “They simply don’t have the infrastructure in place to navigate the procurement agreements and the financial implications of stocking a medication on site and then billing patients for it.”

Other types of doctors like OB-GYNs will also have an easier time prescribing abortion pills with the in-person dispensing requirement gone. But Seattle family physician Dr. Ying Zhang said primary care doctors like family physicians are particularly important for rural communities and certain urban communities that lack access to specialists like OB-GYNs.

For people living in these areas, “their primary care doc is sort of like the person who takes care of most or all of their health care needs,” Zhang said.

However, the availability of abortion pills across the country will remain spotty because of the political battles over abortion access. CVS and Walgreens, the two largest pharmacy chains in the U.S., have announced they will seek certification to dispense mifepristone, but they will only provide it in some states. Both chains initially said they would provide the medication in states where abortion is legal. But in March, Walgreens said it would not sell mifepristone in 20 states, including some where abortion remains legal, in response to a letter signed by the attorneys general of those states threatening the company with legal action.

Currently, the vast majority of abortions in the U.S. are performed at abortion clinics. According to Guttmacher, in 2020 clinics performed 96% of abortions, while just 1% were performed at physicians’ offices.

An increase in doctors prescribing abortion pills could relieve the burden on patients of having to travel to get abortions. According to Guttmacher, in 2017 89% of counties in the U.S. did not have an abortion provider. This meant that, even before Roe v. Wade was overturned, patients in some areas would have to travel long distances, sometimes hundreds of miles, to get abortions.

“When a patient has to travel … for abortion care, that means transportation costs and logistics, often child care costs and logistics, lost wages for missed work and a slew of other hurdles that can significantly delay their access or altogether prevent them from accessing an abortion at all,” Kaye, the ACLU attorney, said.

Kaye said increasing the number of doctors prescribing abortion pills could also reduce pressure on abortion clinics, which are currently experiencing an influx of patients from states where abortion is now banned.

The American Academy of Family Physicians said it supports the removal of the in-person dispensing requirement.

“The FDA’s decision will help family physicians, who are a primary source of comprehensive reproductive health care, provide the best care for their patients,” the physicians group said in an emailed statement to Medill News Service.

Despite the removal of the in-person dispensing requirement, however, barriers still remain to primary care doctors providing abortions, even in states where abortion remains legal.

Zhang, the Seattle family physician, said one such barrier is lack of training. She helps lead a fellowship program that provides family medicine physicians with postgraduate training in abortion care.

According to the Midwest Access Project, which provides doctors training in reproductive health care, fewer than 10% of family medicine residency programs offer routine training in first trimester abortion care.

Kaye said laws in some states are another barrier. Some states have laws restricting access to medication abortion, such as by banning telehealth abortions or requiring patients to take mifepristone in the presence of a doctor.

The remaining mifepristone regulations are also a barrier to doctors providing medication abortions, Kaye said. The FDA currently has several remaining requirements for mifepristone, including certification requirements for prescribers and new requirements for pharmacies.

When asked about the mifepristone regulations, the FDA’s media office referred to the agency’s website, which says that “the goal of the Mifepristone REMS Program is to mitigate the risk of serious complications associated with mifepristone.” According to the FDA’s medication guide for mifepristone, these risks include infection, heavy bleeding and incomplete abortion.

However, abortion rights advocates as well as major medical groups like the American Medical Association, the American College of Obstetricians and Gynecologists and the American Academy of Family Physicians have called on the FDA to eliminate the restrictions on mifepristone entirely. They argue the regulations are unnecessary red tape that are not applied to other drugs with similar safety records.

“Restrictions on abortion do not affect everybody equally,” Kaye said. “They disproportionately harm communities of color and people with fewer resources, and so it is critical that the FDA has taken this one major step forward to remove needless barriers to care. But it is going to continue to be these communities that suffer disproportionately when both the federal government and the state governments needlessly restrict this safe and essential health care.”