Four states petitioned the Food and Drug Administration on Thursday to raise its persistent restrictions on the abortion pills.
The California, Massachusetts, New Jersey and New York prosecutors support in the petition that the current FDA regulations make the prescription of Miffepristone difficult – one of the two pills involved in an abortion of drugs – in primary care establishments, despite proofs that it is sure to do.
“Given the 25 -year security file from Mifepristone, there is simply no scientific or medical reason to subject it to such extraordinary restrictions,” said New York Attorney General, Letitia James, in a statement. “The FDA must follow science and raise these unnecessary obstacles which put patients in danger and repel providers.”
The drug is a central flash point in the debate on abortion. Many anti-abortion groups see restrictions that may obtain mifepristone or cancel its approval as one of the most effective means of limiting access to abortion nationally.
The petition comes only a few days after the FDA commissioner Marty Makary said he was committed to carrying out a security examination of mifepristone.
The Secretary of Health and Social Services Robert F. Kennedy Jr. and Senator Josh Hawley, R-MO., Everyone asked for the exam after the publication of an article, which was neither evaluated nor published in a medical journal, which claimed to find a high rate of serious unwanted events in women who recently took the medication. Researchers who study reproductive health have said that the report is equivalent to junk food and exaggerates the risks of mifepristone. They note that he does not meet the basic research standards, to rely on too large definitions and not to disclose the database she used.
The report was published by the Center for Ethics and Public Policy, a conservative reflection group that served to the consultative council of the 2025 projectA right -wing political initiative that asked the FDA to resume its approval from Miffepristone.
The Attorneurs General said on Thursday that the FDA should use the security examination as an opportunity to remove obstacles to access to mifepristone nationally – or, at least, in the four states involved in the petition.
The FDA regulates certain drugs with serious safety problems via a drug safety program called risk assessment and mitigation strategies (REM). Mifepristone is currently part of this program, although a Research richness has noted that less than 0.5% of women who take it have serious undesirable reactions. Studies have also shown that prescribe mifepristone through the TV East As safe and efficient as to administer it in person.
As part of the REMS program, Mifepristone is subject to a few restrictions: people who prescribe the pills must be certified for health care providers and pharmacies must obtain certifications to provide the drug. Patients who receive mifepristone must also sign a form by attending that they intend to end their pregnancy.
The general prosecutors declared in their petition that these restrictions were heavy and useless. They claim that many primary care physicians and family medicine are unable to assume the administrative burden of being certified to prescribe the pills, or feared to be added to a list of national or local abortion suppliers.
The FDA has already raised several restrictions on mifepristone in the last decade. In 2016, he extended the window in which mifepristone could be used to terminate pregnancies from seven weeks of gestation to 10 weeks. In 2019, he approved a generic form of the drug, which increased the offer. And in 2021, he eliminated a requirement to provide mifepristone in person, allowing the drug to be prescribed by Télésanté and sent by mail.
Anti-abortion groups have called on the FDA to restore these restrictions, often stressing deceptive studies that suggest that the drug has harmful effects. The April report that launched the FDA Safety Review, for example, claims to find a serious complication rate of 22 times higher in mifepristone that said it by the agency.
In their petition on Thursday, the four general prosecutors denounced the recent attempts to challenge the security of Mifepristone, who, according to them, are based on methodologically erroneous research.
A coalition of anti-abortion groups continued the FDA in 2022 for its approval from Miffepristone, citing two studies from the Charlotte Lozier Institute, a group that opposes abortion, which claimed to show serious complications of the drug. The trial was finally rejected by the Supreme Court and the studies were later retracted by a medical publisher.
The Charlotte Lozier Institute published another article last month Affirming that an increasing number of emergency visits after abortions are poorly allocated to false layers, thus masking abortion complications.
Rachel Jones, principal researcher at the Guttmacher Institute, a research organization that supports access to abortion, said that the data captures only a small part of the abortions and is biased in favor of those who are potentially higher. Some of the same data has been used in retracted studies, she said.
Jones added that the time of new reports from anti-abortion groups is not a coincidence.
“Anti-Choix people really leave after the abortion of drugs and do everything they can to get the FDA under the Trump administration to revisit the availability of the medication,” she said.
