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California and three other states petitioned the U.S. Food and Drug Administration on Thursday to ease new restrictions on the abortion pill mifepristone.
“The drug is a lifeline for millions of women who need time-sensitive and need access to critical healthcare, especially low-income women and women living in rural and underserved areas,” said Atty, California. General Rob Bonta filed a petition with Massachusetts Attorney General, New York and New Jersey.
The petition cited Senate testimony last month by Health and Human Services Secretary Robert F. Kennedy Jr. Kennedy said he ordered FDA administrator Martin McCurry to conduct a “full review” of Mifepristone and its labeling requirements.
Experts say the drug, which can be received by mail, has been on the US market for 25 years, and is safely taken by millions of Americans. This is the most common way to end pregnancy in the United States, and is used after the Supreme Court overturned ROE v. Wade in 2022.
The Supreme Court upheld drug access for early pregnancy under previous FDA regulations last year, but it remains a target for anti-abortion conservatives. The Trump administration has given Kennedy Broad Line a rocking American medicine under his “American Health Again Again.” Kennedy quickly ranked health professionals by using vaccine science, and even fake citations, to question vaccine regimens and research and other long-standing public health measures.
At a Senate hearing, Kennedy cited “new data” from a flawed report promoted by anti-abortion groups – not published in a peer-reviewed journal, but raised questions about the safety of Mifepristone and called the report “distrust.”
“Obviously, that indicates at least we need to change the label,” Kennedy said.
Sen. Josh Hawley (R-Mo.) posted a letter from McCurry to X on Monday. McCurry writes that he is “committed to conduct a review of Mifepristone” along with the FDA’s “professional career scientist.”
McCurry said he could not provide additional information in light of the ongoing drug litigation.
In a 54-page petition, the state wrote that “no new scientific data has emerged since the FDA’s last regulatory action that changed the conclusion that Mifepristone remains extremely safe and effective,” and studies that “have been frequently cited to undermine Mifepristone’s extensive safety records” have been widely criticized, or both.
Democrats ridden Kennedy’s efforts to reclassify Mifepristone as politically motivated and unfounded.
“This is another attack on women’s reproductive freedom and scientifically reviewed health care,” Gov. Gavin Newsom said the day after Kennedy’s Senate testimony. “California will continue to protect the rights of all people in order to make their medical decisions and make them available to those who need them.”
Bonta said Thursday that the placement of Mifepristone under the FDA’s risk assessment and known serious side effects, or the mitigation strategy program for REMS’s drugs, would unfairly burden access to “medically unfair” patients and “overburden the entire country’s health system.”
He said Mifepristone “allows people to receive reproductive care as soon as possible when they are safest, cheapest and least invasive.” “It’s safe enough to show a lower risk of serious complications than taking Tylenol,” he said, “it’s supported by science and cannot be erased by any of the Trump administration.”
The FDA previously stated that less than 0.5% of women experiencing the drug have “serious side effects” and deaths are extremely rare.
The REMS program requires prescribers to add their name to the national and local abortion provider list. This is a deterrent for doctors pose a safety threat and requires pharmacies to comply with complex tracking, shipping and reporting requirements.
The patient must also sign a form proof that they want to finish. [their] Bonta said it is deterrent for women in the state who are pursuing criminal penalties against women who use drugs after a miscarriage (one of their common uses) or women seeking specific abortion care.
Under federal law, REMS requirements must address specific risks posed by drugs, cannot “overburden” patients, and new applications to mifepristone “will not meet that standard,” Bonta said.
He said the state petition was not a lawsuit, but rather a regulator’s request to reverse the course, by the FDA.
If the FDA does not do so nationwide, the four petition countries say Bonta’s office already has “strong state laws that ensure safe prescribing, strict informed consent and professional accountability.”
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