FDA’s Decision to Allow Pharmacy Sales of Mifepristone Faces Challenges
Lawsuit against FDA threatens access
EXECUTIVE SUMMARY
The decision by the Food and Drug Administration (FDA) to permit retail pharmacies to dispense medication abortion pills could remove barriers related to time, distance, and costs for patients in states with laws legalizing abortion care.
- Pharmacies can apply for certification to dispense mifepristone. Once certified, they can dispense pills directly to patients with prescriptions.
- Restrictions on mail-order shipping of abortion medications also have been permanently removed.
- One possible risk is a lawsuit filed by the Alliance for Hippocratic Medicine, an anti-abortion group that claims the FDA did not approve mifepristone with sufficient scientific evidence.
In January, the U.S. Food and Drug Administration (FDA) permanently lifted a restriction on medication abortion when it said retail pharmacies could dispense the pills.1,2
Pharmacies must apply for certification of mifepristone, one of the abortion medications. Once certified, they can dispense the pills directly to patients with a prescription. Restrictions on mail-order shipping of abortion medications have been permanently removed.
This was a goal of the Expanding Medication Abortion Access (EMAA) Project since 2018, says EMAA Project Director Kirsten Moore. Before patients will benefit from easier access to medication abortion, pharmacies and more providers will need to take the time and effort to be certified.
While the FDA is moving to make medication abortion more accessible, an anti-abortion group has filed a lawsuit to end all access to mifepristone in the United States.3,4 The Alliance for Hippocratic Medicine sued the FDA on Nov. 18, 2022, claiming the FDA fast-tracked its 2000 approval of mifepristone without sufficient scientific evidence in favor of approval. A federal judge in Amarillo, TX, is expected to issue a decision early in 2023. No decision had been filed at the time Contraceptive Technology Update went to press.
The FDA’s move to expand access to mifepristone was long desired by abortion advocacy groups. “We got to where we thought we would get,” Moore says. “There’s more work to do to get rid of REMS [Risk Evaluation and Mitigation Strategy] altogether, but we feel very good about the promise of pharmacies to stock these medications.”
REMS is an FDA drug safety program that requires certain medications with serious safety concerns to be prescribed and dispensed under more stringent rules. Abortion rights advocates and providers have long said abortion pills have an excellent safety profile and have been incorrectly included in the REMS program.5
“One practical implication that may not be obvious is up until recently, the certified providers had to be doctors, and they had to hand [abortion pills] to patients,” Moore explains. “Now, any licensed medical professional can be a prescriber and write a prescription to it, [although] they still have to be certified.”
Before, certified physicians also had to dispense the pills. Now, certified clinicians can send a prescription to a mail-order pharmacy or to a brick-and-mortar pharmacy. This will improve access for people in states that do not ban all abortions.
“I hope more professionals will become certified prescribers,” Moore says. “It’s as simple as checking three boxes on a piece of paper and signing it.”
Prescribers only need to certify with a signature that they know how to date a pregnancy, detect an ectopic pregnancy, and refer for treatment or complications and back-up care, Moore explains. Mifepristone does not affect an ectopic pregnancy, so if a pregnant patient takes the pill and does not bleed, then something is wrong and an ectopic pregnancy may be the answer.
Although the FDA’s change will have little direct effect on medication abortion access in abortion-ban states, it could help ease waiting lists and congestion at clinics in states that protect abortion rights.
“Clinics are operating at peak capacity, but maybe more people will find tele-abortion services, and that will loosen things up,” Moore says. “We went into this work knowing it wouldn’t help everywhere, but we presumed it would help in certain places and help overall.”
Lawsuit Jeopardizes Access
The positive news is offset by the lawsuit in Texas. “The Alliance for Hippocratic Medicine brought the lawsuit to a judge who is clear about opposing contraception and same-sex marriage,” Moore explains. “They are saying, ‘We think the FDA approved it wrongly, and everything is suspect and not legal, and you, judge, should revoke FDA’s approval of mifepristone.’”
On Jan. 13, Danco Laboratories filed a motion to intervene in the lawsuit. The Mifeprex (mifepristone) manufacturer argued that if the judge grants the plaintiffs’ request, it may block the availability of Mifeprex for medication abortion nationwide as early as mid-February 2023. In a news release, Danco called the lawsuit a “direct challenge to the FDA approval process for all pharmaceutical products.”6
In an opposition to a preliminary ruling in the case, attorneys for the U.S. Department of Justice said that there is an example of a court second-guessing FDA’s safety and efficacy determination and ordering a widely available FDA-approved drug to be removed from the market.7
“It’s jeopardizing FDA’s authority and review and safety of the drug industry at large, and it’s not clear the Supreme Court will see it that way,” Moore says. “If the Texas lawsuit prevails, it will shut down prescribing of the pill, and Danko and GenBioPro will not have the authority to distribute their medication to prescribers here in the United States.”
If the court reverses the legality of mifepristone in the United States, it is possible that some states will go against that decision and encourage mifepristone manufacturers to move to their states, Moore notes. It could be a similar situation to marijuana being sold legally in some states, even when the drug is illegal federally.
There also are extra-legal ways people could obtain abortion medication, including international access through AidAccess.org and mayday.health. AidAccess mails abortion pills to women around the world, even in areas that prohibit their use. Mayday Health tells people how to get abortion pills prescribed and sent to a destination in a safe state, where the pills can be forwarded to people’s homes.
“There may be prescribers who are willing to consult with patients in abortion-ban states,” Moore adds. “There are certainly prescribers who feel strongly about this and are closer to the age of retirement and think, ‘What do I have to lose?’”
REFERENCES
- Aboulenein A. U.S. FDA allows abortion pills to be sold at retail pharmacies. Reuters. Jan. 4, 2023.
- Food and Drug Administration. Information about mifepristone for medical termination of pregnancy through ten weeks gestation. Jan. 24, 2023.
- Mekelburg M. Lawsuit filed against FDA to block access to abortion pill. Bloomberg Law. Nov. 18, 2022.
- Alliance Defending Freedom. Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration. Updated Jan. 30, 2023.
- Food and Drug Administration. Risk Evaluation and Mitigation Strategies. Dec. 17, 2021.
- Danco Laboratories. Danco moves to intervene in lawsuit challenging FDA approval of Mifeprex. Jan. 13, 2023.
- Shutt J. Federal judge could decide as soon as February to yank abortion pill nationwide. Daily Advertiser. Jan. 24, 2023.
The decision by the FDA to permit retail pharmacies to dispense medication abortion pills could remove barriers related to time, distance, and costs for patients in states with laws legalizing abortion care. One possible risk is a lawsuit filed by the Alliance for Hippocratic Medicine, an anti-abortion group that claims the FDA did not approve mifepristone with sufficient scientific evidence.
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