California petition FDA pulls new restrictions on mifepristone, abortion drug for small RFK

California and three other states petitioned the U.S. Food and Drug Administration on Thursday to alleviate new restrictions on the abortion drug mifepristone, citing the drug’s proven safety records and deemed the new restrictions unnecessary.

“This drug is the lifeline for millions of women who need access to time-sensitive, vital health care, especially low-income women and women living in rural and underserved areas,” said Atti, California. General Rob Bonta filed a petition with attorneys in Massachusetts, New York and New Jersey.

The petition quotes the Secretary of Health and Human Services Robert F. Kennedy Jr.

According to experts, the drug can be received by mail, has been on the U.S. market for 25 years and is safely adopted by millions of Americans. This is the most common way to end pregnancy in the United States, with its use surges after the Supreme Court overturned Roe vs. Wade in 2022.

The Supreme Court maintained access to early pregnancy medications in FDA regulations last year, but it remains a target for anti-sugar conservatives. The Trump administration gave Kennedy Broad room to change American medicine with the banner of “make America healthy again”, and Kennedy quickly opened medical experts by using suspicious science (even fake citations) to question vaccine protocols, research, and other long-standing public health measures.

During the Senate hearing, Kennedy listed “new data” of flawed reports promoted by the anti-component group and was not published in any peer-reviewed journal to question the safety of mifepristone, calling the report “shocking.”

“Obviously, this should at least change the label,” Kennedy said.

Senator Josh Hawley (R-Mo.) released a letter to X on Monday by Makary, in which Makary wrote that he was “committed to the review of Mifepristone” and along with the FDA’s “career career scientist.”

Makari said he could not provide additional information about the ongoing lawsuits for the drug.

The states wrote in their 54-page petition: “No new scientific data has emerged since the FDA’s last regulatory action, which would change the conclusion that mifepristone remains abnormally safe and effective, and that “often cited studies have been cited to undermine the widespread security record of Mifepristone has been criticized, has been withdrawn, or both have been withdrawn. ”

Democrats mocked Kennedy for reclassifying Mifescin into politically motivated and unfounded efforts.

“This is another attack on health care for women’s reproductive freedom and scientific commentary,” Gov. Gavin Newsom said the day after the Kennedy Senate testimony. “California will continue to protect everyone’s right to make their own medical decisions and help ensure that people who need it can use mifretone.”

Mifepristone, under the FDA’s risk assessment and mitigation strategy program, targeting drugs with known severe side effects, is “medically unreasonable”, inappropriate patient access, and “pressure on the entire nation’s health system”, Bonta said Thursday.

Mifepristone “allows people to get reproductive care as early as possible in the safest, least expensive and most inviolable situations, “so safe that its risk of serious complications is lower than that of taking Tylenol, while its long-term safety record” and that its long-term safety record is supported by science and cannot be whimsical in the Trump administration.”

The FDA has previously said that less than 0.5% of women who experience “severe adverse reactions” on drugs have experienced, and deaths are extremely rare.

Bonta said the risk assessment program requires prescribers to add their names to the national and local abortion provider list, which could be a deterrent to doctors at risk of safety, and that pharmacies can comply with complex tracking, transportation and reporting requirements, which could be a deterrent to carrying the drug.

It also requires patients to sign forms to prove the “end” [their] Bonta said pregnancy could be a deterrent to women using the drug, one of its common uses, or to punish those who are criminally punishing women seeking certain abortion care.

Under federal law, these requirements must address specific risks posed by drugs and cannot be “too heavy” for patients, and the new application for mifepristone “failed to meet that standard,” Bonta said.

The petitions in the states are not litigation, but regulatory requests to reverse the process to the FDA.

If the FDA does not do so nationwide, four petition states require it to “exercise discretion to not enforce the requirements,” and Bonta’s office said that this already has “strong state laws that ensure safe prescriptions, strict informed consent and professional responsibility.”