Dem AGs demand FDA drop abortion pill safety measures
The Democratic attorneys general of 17 states and the District of Columbia have filed a citizen’s petition with the Food and Drug Administration (FDA) demanding the agency lift safety restrictions on the abortion pill mifepristone.
The petition—originally filed in June by California, New York, Massachusetts, and New Jersey—asks the FDA to remove a set of restrictions called a Risk Evaluation and Mitigation Strategy (REMS). Under this framework, pharmacies must obtain special certification to dispense mifepristone, medical providers must register to prescribe the pill, and women must sign a waiver acknowledging that they are voluntarily terminating their pregnancy before receiving a prescription.
On August 20th, attorneys general from 13 more states—Arizona, Colorado, Connecticut, Delaware, Hawai‘i, Illinois, Maine, Maryland, Michigan, Minnesota, Nevada, New Mexico, Oregon, Rhode Island, Vermont, the District of Columbia, Pennsylvania, and Washington—joined the petition to remove REMS, which has been in place for mifepristone since 2011.
The REMS framework has been applied to 300 other drugs, according to the New York Times. But the attorneys general are claiming that mifepristone already has established safety data since its FDA approval in 2000, and that REMS restrictions are impacting distribution of the pill.
“These extra and unnecessary requirements, which apply to almost no other drugs the FDA regulates, discourage medical professionals from providing medication abortion when they already have the appropriate training to administer the drug,” Washington Attorney General Nick Brown said in a press release.
The AGs are also taking issue with Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. for ordering a complete safety review of mifepristone in May. AG Brown blamed the decision to review the drug as a “response to political pressure,” but it was in fact in response to new data calling the pill’s safety into question.
Mifepristone safety
In April, the Ethics and Public Policy Center (EPPC) published the largest-ever study on mifepristone. Using an insurance claims database, researchers analyzed 865,727 mifepristone abortions between 2017 and 2023. They found that within 45 days of taking the pill, 10.93% of women experienced serious adverse events such as sepsis, infection, cardiac issues, anaphylaxis, or hemorrhage. EPPC notes that this rate is at least 22 times higher than the 0.5% rate displayed on the drug label.
Pro-abortion activists, including legacy media outlets, are trying to discredit the study by pointing out that it has not been peer-reviewed or published in a medical journal, that the researchers lack medical training, and that the authors did not disclose which insurance database they used for their data collection.
The FDA’s prescribing label for mifepristone warns that between 2.9% and 4.6% of women who take the pill require ER visits.
Last year, a team of researchers from the Charlotte Lozier Institute teamed up with physicians from the American Association of Pro-Life Obstetricians and Gynecologists to conduct a study on mifepristone by analyzing ER visits. The researchers selected four cohorts of women: women with no pregnancies, women who gave birth, women who had surgical abortions, and women who had chemical abortions by taking mifepristone. Using data from 2004 to 2015, they looked for any increase in ER visits by these women within 30 days of their outcomes. The group with no pregnancies was analyzed according to all their visits across the 11-year period. They discovered that ER visits among women who gave birth increased by 9.2%, among women with no pregnancies by 42.8%, among women who had surgical abortions by 280.4%, and among women who took mifepristone by 2,649.7%. There was a similar scale for ER visits coded as “severe” or “critical.”
Planned Parenthood nonetheless describes mifepristone as “very safe” and CNN says it’s even safer than low-risk drugs like penicillin.
Who makes mifepristone?
When the FDA approved mifepristone in 2000, it took great care to conceal certain information. All documents related to the approval have been redacted so that government employee names and the location of the manufacturer, Danco Laboratories, remain hidden.
To this day, the location of Danco Laboratories is not known to the public. The company uses a P.O. box as its address, is not listed on any public exchanges, and refuses to disclose the identities of its executives. According to the LA Times, Danco says this is because it fears violence from pro-life groups, though there have been no reports of attacks on Pfizer, which manufactures misoprostol. Misoprostol is a pill used together with mifepristone as part of the chemical abortion regimen.
