WASHINGTON, D.C. — The U.S. Food and Drug Administration has authorized the sale of abortion pills in pharmacies amid several states’ attempts to restrict abortion access.
Mifeprex and its generic mifepristone, also known as RU-486, is FDA approved in a regimen with misoprostol to end a pregnancy up to 10 weeks. The pill was only authorized to be dispensed by a health care provider or physician.
Under new FDA guidance for the mifepristone risk evaluation mitigation strategy (REMS) program, pharmacies can now become certified to dispense the medication by completing a Pharmacy Agreement Form.
“This is welcome news,” ACLU reps stated. “As more states ban abortion and more people suffer the devastating consequences of forced pregnancy, greater access to this medication is crucial.”
Pharmacies that get certified to dispense the mifepristone must be able to ship it using a shipping service that provides tracking information and ensure the pill is dispensed to the patient in a timely manner, the FDA states.
“In 2021, after conducting a review of the Mifepristone REMS Program, the FDA determined that the available data and information support modification of the REMS to reduce burden on the health care delivery system and to ensure the benefits of the product outweigh the risks,” the FDA website states.
The pill can still only be prescribed by a provider certified under the Mifepristone REMS Program, and the risks of the mifepristone treatment regimen must be fully explained to the patient before it can be prescribed. Under the Mifepristone REMS Program, mifepristone may be dispensed in-person or by mail.
There were several attempts in states to ban or restrict the chemical abortion pill prior to the U.S. Supreme Court’s June 2022 decision to overturn Roe v. Wade, which protected a woman’s decision to get an abortion.
“Making chemical abortion pills accessible at your local pharmacy is certainly not the product of the ‘safe, legal, and rare’ lie we were fed as we fought for the reversal of Roe,” said Kristan Hawkins, Students for Life Action and Students for Life of America president, in response to the FDA update.
In Georgia, abortions are now prohibited once a fetal heartbeat is detected (typically at six weeks), with exceptions for medical emergencies, up to 20 weeks for rape, and incest, if a police report is filed.
State Republicans last year attempted to push through Senate Bill 456, a proposal to ban the mailing of abortion pills by doctors via telemedicine — a process that was made possible by the FDA when it modified rules that previously required patients to get the pills in-person, prior to the COVID-19 pandemic.
The Republican dominated Senate voted in favor of the bill March 1, but the bill did not make it to the House floor before the end of the session April 4.
Supporters for that bill said in-person doctor visits for abortion should be required for health and safety reasons, allowing the doctor to verify the pregnancy, diagnose ectopic pregnancies and provide surgical intervention in the case of an incomplete abortion or severe bleeding, among other concerns.
Those against the bill argued that mailing the abortion pill poses no risk to patients and that the bill is an overreach into the medical field. The bill, opponents argued, would have restricted access to health care for women, especially low-income women who may face obstacles getting to a clinic.
Alabama is one of a dozen states that bans abortions at all stages with exceptions for medical emergencies, and the state’s attorney general has said the abortion pills are banned in the state; pharmacies in abortion ban states will likely still be unable to dispense the pills without a court battle.
Before the state’s abortion ban took effect last summer, Alabama Republican Rep. Andrew Sorrell pushed a proposal to prohibit non-surgical abortions or the use of chemical abortion pills in the state. The bill would have made it illegal “to manufacture, distribute, prescribe, dispense, sell or transfer the ‘abortion pill.’”
The proposal asserted that the abortion pill results in complications at a rate four times greater than the rate of complications with surgical abortions.
Guttmacher Institute data shows that in 2020, medication abortion accounted for 54% of U.S. abortions. The FDA estimates that through the end of December 2018, approximately 3.7 million women had used mifepristone in the U.S. for the medical termination of a pregnancy.
The FDA suggests the pills are a safe and effective way of terminating a pregnancy. From September 2002 through December 2018, the FDA reported at least 24 chemical abortion (mifepristone) related deaths and nearly 100 reported uses have led to ectopic pregnancy. More than 1,000 of the 3.7 million abortion pill usages have led to hospitalization.
