Yahoo Finance What's next after the FDA expanded abortion pill access to retail pharmacies
The Food and Drug Administration (FDA) recently took major steps toward increasing access to abortion pills in the U.S. with a rule change that will allow retail pharmacies, including CVS (CVS) and Walgreens (WBA), to begin distributing mifepristone, which may be used in a medication abortion.
This decision builds on the Biden administration's move last year following the Supreme Court's overturning of Roe vs. Wade to lift the requirement that patients pick up the medication in person. It also updates the drug's labeling to allow for its distribution through telehealth consultations and mail delivery where permitted by law.
"The FDA's decision to allow pharmacies to dispense mifepristone with a prescription from a certified prescriber is an important step in allowing women to secure medication they need," Dr. Jennifer Butt, an OBGYN at Upper East Side Obstetrics & Gynecology, told Yahoo Finance. "It's important to remember that mifepristone is not only used for abortions but also treatment of early miscarriages. When used in combination with misoprostol, which is also a prescription drug but more easily accessible, mifepristone can significantly increase the efficacy of treatment of miscarriage."
While the decision promises to expand access to mifepristone, that doesn’t mean pharmacies will begin dispensing the medication immediately.
What is mifepristone and how does it work?
Mifepristone, when taken in combination with the drug misoprostol, can be used to end a pregnancy up to 10 weeks. The medication works by blocking the hormone progesterone, which is necessary for a pregnancy to continue.
According to the Mayo Clinic, for those terminating a pregnancy, the regimen consists of taking a dose of mifepristone followed by a dose of misoprostol 24-48 hours later. Patients then are advised to follow up with a health care provider 7-14 days after taking mifepristone.
Previously, patients could only get Mifepristone through select doctors, clinics, and mail-order pharmacies. Misoprostol, the second drug in the regimen, is already available at many retail pharmacies with a prescription, and the medication is also used for other conditions such as stomach ulcers.
While Dr. Butt doesn't believe there are any safety concerns with the FDA's announcement to allow pharmacies to dispense Mifepristone, she explained patients will still need a prescription from their doctor who "would determine if they were a good candidate for medical treatment and counseled them on any risks beforehand."
What happens next?
Before retail pharmacies begin distributing mifepristone to individuals, they will first have to undergo a certification process.
According to Dr. Ushma Upadhyay, director of research at the University of California Global Health Institute’s Center of Expertise in Women’s Health, Gender, and Empowerment, the certification process is straightforward; however, there will need to be certain systems in place and pharmacists will need to be trained in order to dispense the drug.
"Because there are so many remaining restrictions in place on mifepristone, there are a lot of requirements that the FDA is imposing on pharmacies that plan to dispense mifepristone," Upadhyay told Yahoo Finance. "Pharmacies have to develop a system to track who is prescribing the mifepristone. With each specific prescription, the prescriber would have to fax or email a certification form to that specific pharmacy if the pharmacy doesn't already have one on file. These are the kinds of systems they have to develop so they can ensure with each prescription that comes in that it is written by a certified prescriber."
The pharmacy certification process for mifepristone ensures that pharmacies are knowledgeable about and compliant with the REMS (Risk Evaluation and Mitigation Strategies) program. REMS requirements include the ability to receive prescriber agreement forms via email and fax, the use of a tracking shipping service, appointment of an authorized representative to handle the certification process, and compliance with the Mifepristone REMS Program. This process ensures that mifepristone is only dispensed for prescriptions written by certified prescribers.
In a statement, the American Pharmacists Association called on the FDA "to allow any pharmacy that wishes to dispense mifepristone to become certified, creating a level playing field for all pharmacies."
How long is the certification process expected to take?
While there isn't a specific timeframe in place for the certification process, Upadhyay expects pharmacies to take the decision seriously and begin initiating the certification process as soon as possible.
"It just depends on how much infrastructure they want to have in place before they officially start doing this," she said. "I can imagine that smaller, independent pharmacies will develop their processes as they get their first request. I think pharmacies right now don't have information on what to expect in terms of how many prescriptions they'll receive."
Walgreens has already announced that it intends to become certified to distribute mifepristone.
In a recent statement, Walgreens spokesperson Fraser Engerman stated: "We plan to become a certified pharmacy under the program and are in the process of registering and training our pharmacists, as well as evaluating our pharmacy network to determine the best locations for dispensing mifepristone in compliance with federal and state laws and any additional FDA requirements."
CVS also stated that it plans to "seek certification to dispense mifepristone where legally permissible."
Will it be available at all retail pharmacies?
Upadhyay explained the drug will not be available in every state — particularly where abortion care is banned.
"This change has no benefits for people who live in states where abortion care is banned," Upadhyay said. "It's very likely the CVS [pharmacies] in Mississippi will not carry this medication. States that have abortion bans all have exceptions but CVS' are unlikely to keep mifepristone in stock just for those exceptions."
Still, Upadhyay says she remains optimistic regarding the change and hopes it will normalize conversations around abortion care.
"What I'm hoping that this change will do is impact and normalize abortion care in the United States," Upadhyay said. "People should expect to be able to get these medications from their local pharmacies in the same way they can get their birth control or their STI treatment or any other prescription. This decision makes it clear that mifepristone is safe and should be easily accessible at your local pharmacy. I don't expect it to be available in states that ban abortion, but I am hoping that it will change cultural expectations."
Sandra Salathe is an editor at Yahoo Finance. Follow her on Twitter at @srsalathe
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