January 3, 2023
The New York Times
Mifepristone, the first of two drugs in medication abortions, previously had to be dispensed only by clinics, doctors or a few mail-order pharmacies. Now, if local drugstores or chains like CVS agree to certain rules, they can provide it.
For the first time, retail pharmacies, from corner drugstores to major chains like CVS and Walgreens, will be allowed to offer abortion pills in the United States under a regulatory change made Tuesday by the Food and Drug Administration. The action could significantly expand access to abortion through medication.
Until now, mifepristone — the first pill used in the two-drug medication abortion regimen — could be dispensed only by a few mail-order pharmacies or by specially certified doctors or clinics. Under the new F.D.A. rules, patients will still need a prescription from a certified health care provider, but any pharmacy that agrees to accept those prescriptions and abide by certain other criteria can dispense the pills in its stores and by mail order.
The change comes as abortion pills, already used in more than half of pregnancy terminations in the U.S., are becoming even more sought after in the aftermath of last year’s Supreme Court decision overturning the federal right to abortion. With conservative states banning or sharply restricting abortion, the pills have increasingly become the focus of political and legal battles, which may influence a pharmacy’s decision about whether or not to dispense the medication.
The F.D.A. did not issue an announcement but updated its website to reflect the decision and added to a series of questions and answers. The two makers of the pill, Danco Laboratories and GenBioPro, released statements saying the agency had informed them of the action.
The action is the latest step taken by the federal government to expand access to abortion pills by easing some of the restrictions that have applied to mifepristone since it was approved in 2000.
In December 2021, the F.D.A. said it would permanently lift the requirement that patients obtain mifepristone in person from a health provider, a step that paved the way for telemedicine abortion services which conduct medical consultations with patients by video, phone or online questionnaires and then arrange for them to receive the prescribed pills by mail.
On Tuesday, the F.D.A. officially removed the in-person requirement from its regulatory rule book for mifepristone, leaving in place the remaining two requirements: that health providers be certified to show they have the knowledge and ability to treat abortion patients and that patients complete a consent form.
Mifepristone, which blocks a hormone necessary for pregnancy development, is authorized by the F.D.A. to be taken in the first 10 weeks of pregnancy, although many clinics and telemedicine providers have begun offering it up to 12 or 13 weeks into pregnancy, a step they can legally take because there is scientific evidence that the pills are safe and effective in that time frame.
The second drug in the regimen, misoprostol, has never been as tightly restricted as mifepristone and is used for many different medical conditions; it is easily obtained at pharmacies through a typical prescription process. Misoprostol, which causes contractions that expel pregnancy tissue, is taken 24 to 48 hours after mifepristone.
Tuesday’s action is a result of an agreement between the F.D.A. and the companies that make the pills. The agreement was worked out in negotiations that took about a year and considered issues such as whether to allow pharmacies to offer the pills in stores or only via mail order and how to keep the identity of prescribing doctors confidential to protect their privacy and safety, according to people familiar with the discussions.
Whether large pharmacy chains and local drugstores would opt to make the pills available was not immediately clear Tuesday. A spokesman for Walgreens, Fraser Engerman, said the company would review the F.D.A.’s decision and would “continue to enable our pharmacists to dispense medications consistent with federal and state law.”
The steps for pharmacies to become certified to dispense mifepristone are not difficult, but they involve some administrative requirements that go beyond the process pharmacies use with most other medications, such as designating an employee to ensure compliance. Given the time and resources required by those steps, some pharmacies may not consider it worthwhile to offer a medication that only a small percentage of their customers may use.
But while abortion pills may constitute a small percentage of a pharmacy’s sales, they could have a big impact on its public profile. Calculations about public perception and the highly polarized political landscape are also likely to influence a pharmacy’s decision.
In about half the states, abortion bans or restrictions would make it illegal or very difficult for pharmacies to provide abortion pills.
In states where abortion remains legal, pharmacies may face customer demand for the medication or public pressure from abortion rights advocates and health providers. National chains could decide to offer the medication in those states while not providing it in their stores in restrictive states.
Reaction from advocates on both sides of the abortion debate reflected the country’s deep divisions.
“The Biden administration has once again proved that it values abortion industry profits over women’s safety and unborn children’s lives,” said Marjorie Dannenfelser. the president of Susan B. Anthony Pro-life America. “Abortion activists want to turn every post office and pharmacy into an abortion business, and the Biden F.D.A. is a willing participant.”
Kirsten Moore, the director of the Expanding Medication Abortion Access project, said: “By allowing brick-and-mortar pharmacies to dispense medication abortion care, the F.D.A. is treating medication abortion like the safe, effective, time-sensitive care that it is.”
Mifepristone is currently only approved for abortion. But it is also used in the treatment of some miscarriages, and there may be pressure for pharmacies to dispense it for that purpose as well. Recently, dozens of groups, including the American College of Obstetricians and Gynecologists and the American Medical Association, filed a citizen petition asking the F.D.A. to take action to make it easier for mifepristone to be used for miscarriages.
An official with Danco, which for years was the only company to produce the medication, branded as Mifeprex, said the company expected that smaller independent pharmacies might be first to dispense the drug and that it might take the bigger chains longer, partly because of the logistics involved in complying with the requirements.
The official, who spoke on the condition of anonymity because of the company’s concerns about threats from abortion opponents, said that one logistically intricate step for big chains would be implementing the companies’ requirement that pharmacies keep confidential the names of health providers who prescribe mifepristone. A chain like CVS would not be able to list a doctor’s name in a companywide database, for example, and would have to keep that information restricted to the store that fills that doctor’s prescriptions, the Danco official said.
She predicted that early adopters might include small pharmacies that typically serve university health services or retail pharmacies on hospital campuses, adding that the company wasn’t expecting a boom in sales from the rule change. She said it was also possible that more health care providers would decide to become prescribers if they could now write prescriptions that pharmacies could fill instead of having to stock the medication themselves.
“For some people, this is going to be a huge improvement on their ability to access the drug and be able to even consider this as a choice for themselves,” the Danco official said. “For other people, not necessarily. Maybe they don’t want to go into their small mom-and-pop pharmacy. They’d rather receive it from a mail order where there’s just no interaction that way.”
Evan Masingill, the chief executive of GenBioPro, which makes the generic version of mifepristone, said in a statement: “Today’s F.D.A. announcement expands access to medications that are essential for reproductive autonomy and is a step in the right direction that is especially needed to increase access to abortion care.”
Read More on The New York Times.