The U.S. Food and Drug Administration announced on Thursday afternoon that it will lift certain requirements around medication abortion ― making it easier to access abortion pills across the country.
After nearly a year of reviewing decades-old restrictions on mifepristone ― one of the two drugs used in abortions before 10 weeks ― the FDA decided that it will no longer require in-person dispensing of the drug. This means that most people seeking abortions before 10 weeks will be able to get abortion pills mailed to them from from online or certified pharmacies, after a telehealth visit with a provider.
“The FDA’s decision to permanently remove the in-person pill pick-up requirement is a major step forward that will enable many more patients to get this safe and time-sensitive medication as soon as they are ready, without travel-related expenses and delay,” said Georgeanne Usova, senior legislative counsel at the ACLU. “From the person living in a rural community hundreds of miles from the nearest clinic to the patient who wants to access this essential care in the privacy and comfort of their home, the FDA’s decision will come as a tremendous relief for countless abortion and miscarriage patients.”
The FDA added the stipulation that “pharmacies that dispense the drug be certified,” according to the agency’s website. This is similar to another mifepristone restriction that requires all providers that prescribe abortion pills be specially certified.
“At this time, we have determined that as modified, the REMS [restrictions] will allow for the drug to be dispensed by mail order or specialty pharmacies. We based our conclusions on a comprehensive review of the published literature, other relevant safety and adverse event data, information provided by advocacy groups, individuals and the applicants, and information submitted by plaintiffs in the ongoing Chelius v. Becerra litigation,” the FDA told HuffPost in a statement, clarifying that it doesn’t yet have the data “to determine whether mifepristone for medical termination of early pregnancy can be dispensed through retail pharmacies.”
Although it is not all that rigorous for physicians to register as a certified provider ― and that will likely be the same for pharmacies ― the stigma of adding your name to a list of abortion providers can be a deterrent to some physicians, especially when abortion providers routinely face harassment, legal attacks and violence from anti-abortion extremists.
Medication abortion, also known as abortion pills, is a combination of two drugs: mifepristone and misoprostol. Abortion pills are widely used for miscarriage and abortion care across the country, accounting for about 60% of all abortions in the U.S. in the first 10 weeks of pregnancy. When used together, mifepristone and misoprostol are more than 95% effective and are safer than Tylenol.
Despite the widespread use and safety of abortion pills, the FDA has restricted mifepristone through a drug safety program called the Risk and Evaluation Mitigation System for nearly 30 years. REMS includes three specific requirements, known as Elements to Assure Safe Use: providers must register as certified prescribers in order to authorize abortion pills; patients need to sign a patient agreement and other consent forms before receiving the pills; and mifepristone cannot be dispensed from a pharmacy, meaning it has to be obtained in person.
The FDA is lifting the last restriction ― the in-person dispensing requirement ― which the agency had already temporarily lifted during the pandemic in order to help curb the spread of COVID-19.
When this restriction was in place, patients could get mifepristone only from a certified prescriber in person at a hospital, clinic or physician’s office; the restriction also prohibited retail pharmacies from stocking and dispensing the medication. Lifting this in-person restriction is a big milestone because it will allow certified prescribers to submit a prescription for medication abortion to mail-order pharmacies. Those pharmacies then deliver the pills directly to a patient’s home where, usually following a telehealth consultation, they can undergo an abortion from the safety and privacy of their own home.
While the announcement was a big step forward, Usova of the ACLU and other advocates were discouraged that the FDA did not lift all three restrictions on mifepristone.
“While the action today will go a long way for people seeking care, other barriers remain and must be lifted once and for all,” said Destiny Lopez, co-president of the abortion rights organization All* Above All. “At a time when abortion care is under attack like never before, especially for folks working to make ends meet, we can’t afford partial solutions. The FDA must permanently lift all restrictions on medication abortion and states with politically motivated bans on medication abortion, particularly via telehealth, must reverse these policies so people can get care in a way that makes sense for them.”
“The reality is this: FDA makes a good decision, Roe falls and we’re still going to be in this insane place of women in some states being able to access an FDA-approved drug and women in other states not being able to access an FDA-approved drug,” she said. “And that’s just nuts.”