The Commonwealth of Massachusetts, along with the states of California, New Jersey, and New York, has submitted a Citizen Petition to the U.S. Food and Drug Administration (FDA) to remove the only safety standards standing between women and complete unfettered provision of chemical abortion drugs devoid of medical oversight.
A Citizen Petition is a way for individuals, regulated industry representatives, or consumer groups to petition the FDA to issue, amend, revoke a regulation, or to take other administrative action.
Abortion states have increasingly shown themselves since the 2022 Dobbs ruling as their leadership has prioritized pushing abortion, at the same time leadership in life states has concurrently acted to protect life through policy.
Pro-abortion attorneys general from Massachusetts, California, New Jersey, and New York requested in their June 5 Citizen Petition for the FDA to remove its Risk Evaluation Mitigation System (REMS) for chemical abortion drug mifepristone and asked that the FDA not enforce certain aspects related to prescriber, patient, and pharmacy certification in their states.
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The REMS “is a drug safety program that the U.S. Food and Drug Administration (FDA) can require for "certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks,” according to the FDA.
Abortion drug mifepristone, the first of two drugs in the chemical abortion regimen, has been the subject of ongoing controversy since the Obama and Biden administrations loosened safety standards put in place with the drug’s dubious approval in 2000, with pregnancy help and pro-life advocates having long advocated for stronger safety measures for it - while abortion apologists insist it’s as safe as over the counter pain medicine.
Mifepristone starves the unborn child of necessary nutrients by blocking progesterone in the pregnant mother’s system. The second drug in a chemical abortion, misoprostol, is taken a day or so after mifepristone, causing the woman to go into labor and deliver her presumably deceased child.
Among the minor side effects possible with mifepristone are cramping, nausea, and vomiting. Severe complications that require immediate medical attention include extremely heavy bleeding, severe infection, and retained tissue.
When complications from chemical abortion occur, the woman is largely left to deal with them at home, potentially alone.
Safety concerns beyond the minor side effects of mifepristone as compiled by the Charlotte Lozier Institute (CLI) include:
Chemical abortion has a complication rate four times that of surgical abortion, and as many as one in five women will suffer a complication.
As many as 15% of women will experience hemorrhage, and 2% will have an infection. The risk of incomplete abortion and infection increases with increasing gestational age.
Chemical abortion drugs are increasingly likely to send women to the emergency room (ER): in a study of the Medicaid population in states that fund abortion for low-income women, the rate of chemical abortion-related emergency room visits increased over 500% between 2002-2015.
Chemical abortions are over 50% more likely than surgical abortions to result in an ER visit within 30 days, with one woman experiencing an abortion-related ER visit for every 20 chemical abortions.
CLI’s data covers social and emotional risks and risks specific to abortion-by-mail as well.
Pro-life concerns about mifepristone include the physical risk to women but also the possibility for the drug would be used in human trafficking and other scenarios involving abuse or coercion.
The REMS for mifepristone that have been removed by the FDA include an initial in-person doctor visit to screen for ectopic pregnancy and other serious conditions, and a follow-up visit to check for life-threatening complications such as internal bleeding and infection. The FDA then weakened its REMS requirements for mifepristone in permitting it to be mailed and also dispensed by pharmacies.
Part of the FDA’s reducing of its safety standards for mifepristone has also included eliminating the requirement that abortion providers report non-fatal adverse events to the FDA Adverse Event Reporting System.
Estimates vary but all indicate that chemical abortions account for a decisive majority of all abortions conducted in the U.S.
The Ethics and Public Policy Center study released in late April found that the abortion pill is 22 times more dangerous than previously recognized in FDA data.
Pro-life Members of Congress have urged the administration to take up the mifepristone safety issue.
Additionally, Trump Cabinet officials HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Dr. Marty Makary have repeatedly indicated the administration would address safety concerns for mifepristone.
The Massachusetts, California, New Jersey, and New York AGs said in their June 5 Citizen Petition that their petition was prompted by HHS Secretary Robert F. Kennedy Jr. testifying before the Senate Health, Education, Labor and Pensions Committee May 14 that he had ordered FDA Commissioner Marty Makary to conduct a complete review of mifepristone and its labeling requirements.
The abortion states then proceeded to make the case that mifepristone is “extraordinarily safe,” using the term "safe" in the petition 150 times in some form.
Representatives from the largest network of pregnancy help organization in the U.S. denounced the abortion state AGs’ effort to further weaken FDA safety standards and put women at additional risk.
"Does the State of Massachusetts not have internet?” asked Heartbeat International President Jor-El -Godsey. “That would be the only plausible reason that they missed the largest real-world study on the harms women are experiencing with mifepristone abortions.”
Tweet This: Does the State of Massachusetts not have internet? That would be the only reason they missed the study on the harms of mifepristone abortion
“Surely care and caution for women would mean further study is warranted and not a rush to eliminate risk evaluation and mitigation," Godsey said.
“It’s ironic that the phrase ‘safe and effective’ is used often in this letter to describe a process that intentionally ends a human life,” said Heartbeat International Vice President of Communications & Marketing Andrea Trudden.
“No amount of regulatory wordplay can erase the fact that every use of this drug is designed to stop a beating heart,” she said. “That alone demands the highest level of scrutiny—not less.”
“Why would attorneys general want to deny women access to the full picture—including updated studies that suggest serious risks?” Trudden asked. “The FDA shouldn’t sweep emerging data under the rug; it should do what science demands: review it honestly and transparently.”
Godsey noted how the narrative from abortion proponents has continually shifted to prioritize protecting abortion access despite safety concerns.
"The mantra from Big Abortion allies of the past was, 'Abortion should be between a woman and her doctor,'” he said. “Abortion states have been working to remove the doctor and now comes their effort to kneecap health guidance for the woman and her doctor on mifepristone.”
“Leaders elected to serve the public should be working for the public and not for the special interest of Big Abortion," Godsey said.
Editor's note: Heartbeat International manages Pregnancy Help News.
