The Food and Drug Administration announced it has loosened some restrictions on the pill mifepristone, allowing it to be dispensed by more pharmacies and without an in-person exam.
Charlie Neibergall/AP
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Charlie Neibergall/AP
The Food and Drug Administration announced it has loosened some restrictions on the pill mifepristone, allowing it to be dispensed by more pharmacies and without an in-person exam.
Charlie Neibergall/AP
More than half of all U.S. abortions are medically induced through a two-pill regimen that requires a prescription but does not involve surgery. And since Roe v. Wade was overturned in June, rates are expected to increase.
Now, a permanent rule change by the Food and Drug Administration will allow retail pharmacies to fill prescriptions for the drugs, making the once onerous process of obtaining the abortion pills much easier in states that permit the procedure. But in places with strict anti-abortion bans, pregnant people may still find it challenging to get their hands on the medication.
What does the FDA’s new rule change?
The revision by the FDA announced on Tuesday permanently eliminates the requirement of an in-person doctor’s visit for a prescription of mifepristone, a drug that stops the hormone needed to maintain a pregnancy in the first trimester. The medication has been approved by the FDA for more than two decades but the only way to get it has been from certified clinics due to safety concerns. Retail chains were specifically barred from dispensing the medication.
The agency lifted the mandatory face-to-face with physicians at the start of the pandemic, allowing them to prescribe the pill via telehealth appointments. This week the FDA said that after a review, the restrictions were no longer necessary.
Mifepristone is used to terminate pregnancies of up to 10 weeks. It works when it is followed up with a dose of misoprostol, usually taken 24 to 48 hours later. The second pill causes the uterus to expel the pregnancy. (Doctors also use both pills during miscarriages to speed things along and minimize infection risk.)
Where will the pills be available and who will have access?
Now that big pharmacy chains are no longer barred by the FDA from carrying and filling prescriptions for mifepristone, the medication could be available at local drugstores and pharmacy retailers. They can also continue to be sent through the mail after telehealth appointments.
While no one is required to carry them, pharmacies that wish to dispense the pills would need to meet certain requirements and receive special certification from the FDA. And, in all cases patients still need a prescription. (They will not be available as over-the-counter medications.)
On Wednesday, Walgreens said it plans to pursue certification.
“We intend to become a certified pharmacy under the program,” Fraser Engerman, a spokesman for Walgreens, told NPR in a statement.
He added: “We are working through the registration, necessary training of our pharmacists, as well as evaluating our pharmacy network in terms of where we normally dispense products that have extra FDA requirements and will dispense these consistent with federal and state laws.”
CVS said it was looking at requirements in states that don’t already restrict the drugs for medication abortion.
Medical societies say it’s a step forward, especially for people who have been marginalized by the health care system.
“Many people have difficulty accessing this care because of things like transportation or having time off of work to go to a clinic to get this care so this is really going to open the doors for them,” Dr. Kristyn Brandi, a member and fellow at the American College of Obstetricians and Gynecologists told NPR.
She added that the FDA’s conclusion that patients are not at an increased risk by not seeing a doctor in-person, might pave the way for providers who may have previously been nervous about seeking certification.
“I’m hopeful that they will sign on and be able to increase access to their communities,” Brandi said.
What about states that limit abortion pill access?
Pregnant people living in states that already limit or ban abortion pill access will likely not benefit from the FDA’s new rules.
According to the Guttmacher Institute, which tracks state laws and policies surrounding abortion, 29 states specifically require physicians to administer medication abortions. Eighteen of those states have already effectively banned the pills’ use in telemedicine by requiring a clinician to be in the room when a patient takes the mifepristone. That means sometimes people have to schedule an initial appointment to get the prescription and if the office or clinic is out of stock then the patient has to return for a second visit to take the pill in front the doctor or clinician.
Meanwhile, Texas outright banned two-pill regimen after seven weeks of pregnancy.
Anti-abortion activists and legislators have driven the push against abortion medication, saying that easing prescription requirements is dangerous.
Sue Liebel, director of state affairs for the Susan B. Anthony Pro-life America, an organization that calls itself “the political arm of the pro-life movement, called the more lax rules “a disaster waiting to happen.”
“It is just super reckless that the FDA would peel back these safety regulations [requiring] an in-person exam. I find it heartless that women’s health and safety was not taken into account,” Liebel told NPR.
She suggested that as a result, more women “will wind up in the emergency room.” But when pressed for data that might show any increases in ER visits since the FDA temporarily lifted the in-person mandate, she was unable to point to recent studies.
Liebel said she expects to hear from lawmakers in the coming days about how they intend to move forward.
“I think this next policy session is going to be very fascinating,” she said. “We’re in some new territory here with the decision. t’s going to be a mixed bag to be honest with you in terms of what states will try do and see what works.
What safety measures are in place to protect patients?
The Mayo Clinic lists excessively heavy vaginal bleeding and unusual tiredness or weakness among the more serious side effects of mifepristone that would require immediate medical attention. Still, the physicians and medical societies say medical complications are very rare.
“The people that actually need emergency care after receiving the proposal is less than 1%,”Dr. Kristyn Brandi of ACOG told NPR.
She added that forcing patients to get the pills in person does nothing to improve medical treatment or prevent a negative response.
“I would say that there’s absolutely no data that suggests that people are going in waves to seek emergency care after medication and that’s because there is a really great track record showing that they are incredibly safe,” Brandi said.
She also notes that clinical care is not going to change very much. “Patients will still be evaluated by experienced clinician. They’ll go through counseling. They’ll be able to talk about whether or not this is the best choice for them.”
The only difference, moving forward she explained, is that in the most dire situations they will no longer have to drive long distances for an exam or wait days to obtain the vital medication. “They’re just going to have much more easy access to it.”
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