Update on March 8 at 2:50 p.m. PT: After significant backlash, Walgreens walked back its plan not to dispense abortion pills in states where abortion is still legal. In a statement on Monday, March 6, the pharmacy chain vowed to offer mifepristone where it is still possible to do so.
“We want to be very clear about what our position has always been: Walgreens plans to dispense mifepristone in any jurisdiction where it is legally permissible to do so,” Walgreens said in its statement. “Providing legally approved medications to patients is what pharmacies do.”
Original story from March 3, titled “Despite New FDA Allowance, Walgreens Pharmacies Refuse to Dispense Abortion Pill Mifepristone in Several States”:
Walgreens announced Thursday, March 2, that it will not dispense mifepristone—one of two abortion pills—in the following 20 U.S. states out of an abundance of caution: Alabama, Alaska, Arkansas, Florida, Georgia, Indiana, Iowa, Kentucky, Louisiana, Mississippi, Missouri, Montana, North Dakota, Ohio, Oklahoma, South Carolina, South Dakota, Texas, Utah and West Virginia. The list includes several where abortion remains legal—like Alaska, Iowa, Kansas and Montana.
Amidst an ever-changing set of laws regarding abortion care, pharmacists say they’re struggling to navigate “blatant contradictions between state and federal law that make it very challenging to identify what is legal and what is not legal,” according to E. Michael Murphy, a spokesperson for the American Pharmacists Association. “We are very concerned … because we as pharmacists want to ensure the patients have access to the best possible care that’s informed by evidence.”
The announcement is a response to a letter sent to Walgreens in February by nearly two dozen Republican state attorneys general, who threatened legal action if Walgreens dispenses the drugs. The AGs sent similar letters to CVS, Albertsons, Rite Aid, Costco, Walmart and Kroger. As of Friday morning, the companies had not issued their own statements regarding their plans for mifepristone distribution in the 20 states—though in January, fellow retail pharmacy chain CVS had said they would seek certification to sell abortion pills in states where legally permissible.
Walgreens doesn’t currently distribute the drugs anywhere in the U.S. but is still undergoing a certification process in order to do so in some states—though a company spokesperson declined to say which states.
FDA Says Pharmacies Can Sell Abortion Pills
On Jan. 3, the U.S. Food and Drug Administration (FDA) announced a new certification process for brick-and-mortar pharmacies to become eligible to sell the abortion pill mifepristone for the first time. Reproductive rights advocates looking to expand access to abortion pills celebrated the change.
“Today’s announcement means that people who live in states that have not banned medication abortion care may soon be able to walk into their neighborhood pharmacy and walk out with their medications in hand,” said Kirsten Moore, director of Expanding Medication Abortion Access (EMAA) Project, a leading advocate for increased access to medication abortion. “By allowing brick-and-mortar pharmacies to dispense medication abortion care, the FDA is treating medication abortion like the safe, effective, time-sensitive care that it is.”
In December 2021, the FDA announced the policy change to allow certified pharmacies to sell abortion pills, and have since then been negotiating with the abortion pill manufacturers Danco and GenBioPro to develop a process to certify pharmacies.
“We applaud the FDA for lifting unnecessary requirements on medication abortion,” said Morgan Hopkins, president of All* Above All in January, in response to the FDA’s original announcement. “This brings us one step closer toward a future where people can get the care they need in ways that are comfortable and make sense for them, including at a local pharmacy like any other prescription.”
This change will empower patients who choose medication abortion to have the option of going to a pharmacy for immediate care, rather than waiting for a mail order if that is right for them.Dr. Iffath Abbasi Hoskins
Before the change, certified providers had to stock and distribute the pills themselves, or rely on mail order pharmacies that distribute the medication, including American Mail Order Pharmacy, Manifest Pharmacy and Honeybee Health. Under the new certification process, providers can just write a prescription and have it filled by local brick-and-mortar retail pharmacies that allow it.
“Allowing for brick-and-mortar pharmacies to join mail-order pharmacies in dispensing mifepristone for reproductive health indications will further improve access for patients,” said Dr. Iffath Abbasi Hoskins, president of the American College of Obstetricians and Gynecologists (ACOG). “ACOG has long advocated that mifepristone be made available in retail pharmacies, just like other prescription drugs, to allow more patients access to abortion care without clinically unnecessary hurdles. This change will empower patients who choose medication abortion to have the option of going to a pharmacy for immediate care, rather than waiting for a mail order if that is right for them.”
Pharmacy-Dispensed Mifepristone Is Proven Safe and Effective
Research has shown that pharmacist dispensing of medication abortion is safe, effective and acceptable to patients.
“While long overdue, the FDA’s announcement is a step in the right direction,” said Dr. Ushma Upadhyay, professor at Advancing New Standards in Reproductive Health and an expert on the safety and effectiveness of medication abortion. “The science is clear that medication abortion is safe and effective, whether provided in a clinic or at home via telehealth.”
But the FDA is still requiring pharmacies to register with the drug manufacturer in order to distribute the drug, despite the fact that mifepristone is safer than many over-the-counter medications, including Tylenol.
“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,” said Upadhyay.“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.”
“This is just a bunch of paperwork that doesn’t add any value,” said Moore, who admitted it may be a while before mifepristone is available in pharmacies.
Even as the FDA drops one onerous restriction, it adds another—a certification requirement for pharmacies, which is not supported by medical evidence.Dr. Ushma Upadhyay
Mifepristone remains within the FDA’s highly restrictive Risk Evaluation and Mitigation Strategies (REMS) drug safety program, which tightly controls medications, despite exhaustive research proving that abortion pills in the first trimester are very safe and effective.
Under the REMS restrictions, healthcare providers also have to register with the drug manufacturer to become certified to prescribe mifepristone, which greatly limits the number of qualified providers and has no medical benefit.
“These certification requirements unfairly limit the pools of prescribers and pharmacies for no good reason,” said Moore.
The American College of Obstetricians and Gynecologists, the American Medical Association and the American Academy of Family Physicians have all issued statements opposing the FDA REMS restrictions and certification requirements for mifepristone because they have no basis in medicine and create barriers to time-sensitive abortion and miscarriage treatment.
Moore nevertheless hopes pharmacy distribution will mean more medical providers will be willing to become certified and prescribe abortion pills in the future. “We are moving this product from what used to be a very niche category with a very small circle of players into the mainstream.”
Moore said pharmacy access is important to normalizing abortion pills and making them more accessible. “Permanently lifting the in-person dispensing requirements and allowing patients to get care by mail after a telehealth visit or at the pharmacy is a step in the right direction,” said Moore. “Today, we celebrate this progress and tomorrow, we’ll continue to work towards a world with no restrictions on medication abortion care.”
This story was originally published on Jan. 6, 2023, under the headline: “FDA Allows Pharmacies to Sell Abortion Pills—But Requires Unnecessary and Burdensome Certification Process.”
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