California and three other states petitioned on the United States Food and Drug Administration on Thursday to facilitate its new restrictions on the abortion pill, mifepristone, citing the proven medication security file and saying that the new limits are not necessary.
“The drug is a rescue buoy for millions of women who need access to critical and time -sensitive health care – especially low -income women and those who live in rural areas and badly served,” said California Atty. General Rob Bonta, who deposited the petition alongside the Attorneurs General of Massachusetts, New York and New Jersey.
The petition cites the testimony of the Senate by the Secretary of Health and Social Services Robert F. Kennedy Jr. last month, in which Kennedy said that he had ordered the administrator of the FDA Martin Makary to carry out a “full examination” of the Miffepristone and his labeling requirements.
The drug, which can be received by mail, has been on the American market for 25 years and taken safely by millions of Americans, according to experts. This is the most common method to put an end to pregnancy in the United States, with its use after the Supreme Court canceled Roe against Wade in 2022.
The Supreme Court confirmed access to the drug for early pregnancies under the previous regulations of the FDA last year, but it remained an objective of the anti-abortion preservatives. The Trump administration gave Kennedy Broad Rein to shake American medicine under his banner “Make America Healthy Again”, and Kennedy quickly ranked medical experts using questionable sciences – and even false quotes – to question therapeutic and research schemes and other long -standing public health measures.
During the Senate hearing, Kennedy cited the “new data” of a defective report pushed by anti -abortion groups – and not published in a newspaper evaluated by peers – to question the security of mifepristone, calling the “alarming” report.
“Obviously, this indicates that, at the very least, the label should be modified,” said Kennedy.
Senator Josh Hawley (R-MO) published a letter from Makary on Monday on Monday, in which Makary wrote that he was “determined to carry out an examination of mifepristone” alongside “professional career scientists” at the FDA.
Makary said he could not provide additional information giving current litigation around the medication.
The States, in their 54 -page petition, wrote that “no new scientific data has emerged since the latest FDA regulatory actions which would modify the conclusion that Miffepristone remains exceptionally safe and effective” and that the studies “which were frequently cited to undermine the two security files of Mifepristone have been widely criticized, or both”.
Democrats have ridiculed Kennedy’s efforts to reclassify mifepristone as politically motivated and baseless.
“This is another attack on the reproductive freedom of women and health care care for scientific evaluation,” said Governor Gavin Newsom the day after the Kennedy Senate. “California will continue to protect the right of each person to make their own medical decisions and help guarantee that mifepristone is accessible to those who need it.”
BONTA said Thursday that Mifepristone’s placement in the risk assessment strategy program and FDA attenuation for drugs with serious and serious side effects – or REM – was “medically unjustified”, unduly overwhelmed access to patients and has exerted “undue pressure on the whole of the country’s health system”.
He declared that mifepristone “allows people to obtain reproductive care as soon as possible when it is the surest, the cheapest and the least invasive”, is “so sure that it has lower risks of serious complications than to take tylenol”, and that its long security file “is supported by science and cannot be erased in the guidance of the administration of Trump”.
The FDA previously said that less than 0.5% of women who take the drug experience “serious adverse reactions” and deaths are extremely rare.
The Rems program forces prescribers to add their names to the national and local lists of abortions suppliers, which can be dissuasive for doctors with security threats and pharmacies to comply with complex monitoring, shipping and declaration requirements, which can be dissuasive to carry the drug, said Bonta.
It also forces patients to sign forms in which they testify to want to “finish [their] Pregnancy “, which, according to Bonta, can be dissuasive for women using the drug after a miscarriage – one of its current uses – or for states in states pursuing criminal sanctions for women in search of certain abortion care.
Under the federal law, the requirements of the REMS must meet a specific risk posed by a drug and cannot be “unduly heavy” on patients, and the new mifepristone request “does not comply with this standard,” said Bonta.
The petition of states is not a trial, but a regulatory request for the FDA to reverse the course, states said.
If the FDA would not do it nationally, the four states of petition asked that it “exercises its discretionary power not to apply the requirements” in their states, which, according to Bonta, already has “robust state laws which guarantee a safe prescription, rigorous informed consent and professional responsibility”.
