Boston Globe | The FDA allowed pharmacies to dispense abortion pills. But will they do it?

Despite administrative rules, advocates hope most pharmacies in Mass. will offer them.

By Felice Freyer
Story Originally Posted in the Boston Globe

The Food and Drug Administration’s decision Tuesday to permit pharmacies to dispense abortion pills has been hailed as a major step in easing access to the procedure. But it’s unclear how many pharmacies will offer the drugs.

Although the ruling includes administrative requirements that could deter some pharmacies, abortion rights advocates expressed optimism that in states like Massachusetts where abortion is legal, most drugstores would make the pills available.

CVS and Walgreens said they planned to seek certification to sell the pill. The pharmacy chains did not provide details about when they expected to be able to offer the pills, in which states, or whether they would offer them only in stores or via mail order, or both. They said they would comply with laws in states that ban or restrict abortion, currently about half of the states.

Mike Wilson, president of the Massachusetts Independent Pharmacists Association, said that he expects that most of the state’s approximately 80 independent community pharmacies will take on the task.

“This will be a huge step toward increasing access and personal autonomy,” said Rebecca Hart Holder, president of Reproductive Equity Now, a Massachusetts-based advocacy group. “This mainstreams abortion care.”

At issue is mifepristone, the first of two drugs administered to end a pregnancy of 10 weeks or less. Until now, mifepristone could only be obtained directly from a physician or clinic, or through a few online pharmacies. A rules change posted late Tuesday now means that people can get a prescription and pick up the pills at their local drugstore, as they would any other medication.

For the pharmacist, however, it won’t be exactly like any other medication. The pharmacy must become certified to provide the drug by documenting its ability to meet procedural standards such as confirming that the prescriber is certified, maintaining records, and protecting the confidentiality of doctor and patient.

Kirsten Moore, director of the Expanding Medication Abortion Access Project, called the decision a “turning point” in an ongoing process to increase access to medication abortion.

It remains to be seen, Moore said, whether the big pharmacy chains will decide that providing a drug for one-time use is worth the paperwork burden. Still, in talking with representatives of the national chains, Moore said she was left with the impression that they intend to “figure out a way to dispense it.”

Mifepristone blocks a hormone needed for a pregnancy to continue. Misoprostol, taken a day or two later, causes contractions to expel tissue. Misoprostol was already widely available because it is used for a range of other conditions.

Together, these two medications have become an increasingly popular way to obtain abortions, accounting for 53 percent of abortions nationally in 2021, according to the Guttmacher Institute, a research organization that favors abortion rights.

In 2021, the FDA removed a requirement that mifepristone could only be prescribed in person, but kept in place the prohibition on picking up the drug at a pharmacy as well as a requirement that doctors be certified to prescribe the drug.

Tuesday’s decision will further increase access to a medication known to be very safe, Hart Holder said.

She called on the large chain pharmacies and big box stores “to set the pace here and go through the certification process to dispense mifepristone.”

Wilson, of the independent pharmacists, said that pharmacists’ growing role in providing vaccinations and treatments for COVID-19 has shown that they can be an important resource, especially in rural areas, and the FDA’s decision further amplifies their role.

The certification requirements involve “a couple of extra steps,” and don’t seem onerous, said Wilson, who co-owns Crawford Drug in Dorchester. Once the pharmacist is certified, “It becomes a normal part of filling the prescription,” Wilson said.

Another hurdle that may slow the process, Wilson noted, is waiting for insurance companies to adjust their systems. Now insurers cover the drug as part of the plan’s medical benefit; once it’s available in pharmacies it will be included in the pharmacy section of their policies.

The decision is especially important for people who cannot visit a doctor, such as someone in a violent relationship who doesn’t want her partner to know about the abortion, or people in rural areas where few doctors are certified to prescribe abortion pills. Patients will be able to obtain a prescription via telehealth and pick up the medication at their local drugstore.

Dr. Ushma Upadhyay, professor at Advancing New Standards in Reproductive Health, a research program based at the University of California San Francisco, called on the FDA to go further in easing access.

“Even as the FDA drops one onerous restriction, it adds another — a certification requirement for pharmacies which is not supported by medical evidence and could present a large enough hurdle that will dissuade some from dispensing,” she said in a statement. “With abortion restricted in large parts of the country, we need our public health policies to follow the science so people can have access to this essential medication.”

Dr. Kristyn Brandi, a New Jersey obstetrician-gynecologist and the Darney-Landy fellow at the American College of Obstetricians and Gynecologists, called the FDA decision “a great step forward,” but agreed that the FDA should remove the other restrictions.

“Medication abortion is incredibly safe, and has fewer side effects than common medications like aspirin and penicillin,” Brandi said in a statement. “This is an evidence-based regimen of medication that many people are safely prescribed. There is no reason it should not be available for patients with a prescription to pick up from their preferred pharmacy.”