FDA rejects petitions on use of abortion pill mifepristone

Photo courtesy CVS Health

The Food and Drug Administration has rejected two petitions on the use of the abortion pill mifepristone.

On January 3, the FDA denied the request of Students for Life of America in a December 13 petition asking the FDA to reverse its recent modifications for use of the abortion pill.

The group wanted mifepristone:

• only to be administered for up to seven weeks gestation rather than the FDA-allowed 10 weeks.
• only to be prescribed under the supervision of a physically-present physician.
• to require three office visits.
• to be only for patients who do not have convenient access to emergency medical care.
• to be prescribed by telehealth only if a women is in absolute need under extreme circumstances.

"The actions you request in your petition are the same or substantially the same as the actions requested in the March 29, 2019 citizen petition submitted by the American Association of Pro-Life Obstetricians and Gynecologists (AAPLOG) and the American College of Pediatricians (ACP), which were addressed in FDA's December 16, 2021 response to that petition," said Patrizia Cavazzoni, director of the agency's Center for Drug Evaluation and Research, in her denial of the request. "Your petition does not provide any new data or evidence."

The FDA also rejected a petition from the American College of Obstetricians and Gynecologists. The group asked that the pills be easier to obtain for patients using them to treat a miscarriage rather than an abortion.

WHY THIS MATTERS

This week, the FDA loosened restrictions for the abortion pill by allowing retail pharmacies to dispense it.

Mifepristone is approved, in a regimen with misoprostol, to end an intrauterine pregnancy through ten weeks of gestation.

Walgreens and CVS both plan to get certified to dispense mifepristone to patients in states where abortion remains legal, according to CNBC.

To become certified to dispense mifepristone, pharmacies must complete a Pharmacy Agreement Form, according to the FDA.

The FDA's new regulatory modifications to the Mifepristone Risk Evaluation and Mitigation Strategy (REMS) were made on January 3.

In 2021, after conducting a review of the Mifepristone REMS Program, the FDA said it determined that the available data and information support modification of the REMS to reduce the burden on the healthcare delivery system and to ensure the benefits of the product outweigh the risks.

The FDA first approved a generic version of mifepristone tablets in 2019.

THE LARGER TREND

The petitions are the latest in the ongoing battle over abortion since the Supreme Court in June overturned federal abortion rights in Roe v. Wade in the case of Dobbs v. Jackson Women's Health Organization. The decision over abortion rights now rests with individual states.

In August, President Biden signed an executive order on emergency abortion access that also clarified that women can travel out-of-state to get an abortion in states where it is legal. However, almost three quarters of physicians said in a September survey they were unclear on what constituted a life-threatening emergency that would allow them to legally perform an abortion in states where it is otherwise banned.

ON THE RECORD

"Since the Dobbs decision, anti-abortion legislators across the country have been building barriers to abortion access. Concrete action at the federal level--like allowing retail pharmacies to provide mifepristone – is exactly what we need," said Monica Raye Simpson, executive director of SisterSong.

Others applauding the FDA modifications include the National Abortion Federation, Advocates for Youth and Physicians for Reproductive Health.

Twitter: @SusanJMorse
Email the writer: SMorse@himss.org