mifepristone

California and three other states petitioned the U.S. Food and Drug Administration Thursday to ease its new restrictions on the abortion pill mifepristone, citing the drug’s proven safety record and arguing the new limits are unnecessary.

“The medication is a lifeline for millions of women who need access to time-sensitive, critical healthcare — especially low-income women and those who live in rural and underserved areas,” said California Atty. Gen. Rob Bonta, who filed the petition alongside the attorneys general of Massachusetts, New York and New Jersey.

The petition cites Senate testimony by Health and Human Services Secretary Robert F. Kennedy Jr. last month, in which Kennedy said he had ordered FDA administrator Martin Makary to conduct a “complete review” of mifepristone and its labeling requirements.

The drug, which can be received by mail, has been on the U.S. market for 25 years and taken safely by millions of Americans, according to experts. It is the most common method of terminating a pregnancy in the U.S., with its use surging after the Supreme Court overturned Roe vs. Wade in 2022.

The Supreme Court upheld access to the drug for early pregnancies under previous FDA regulations last year, but it has remained a target of anti-abortion conservatives. The Trump administration has given Kennedy broad rein to shake up American medicine under his “Make America Healthy Again” banner, and Kennedy has swiftly rankled medical experts by using dubious science — and even fake citations — to question vaccine regimens and research and other longstanding public health measures.

At the Senate hearing, Kennedy cited “new data” from a flawed report pushed by anti-abortion groups — and not published in any peer-reviewed journal — to question the safety of mifepristone, calling the report “alarming.”

“Clearly, it indicates that, at very least, the label should be changed,” Kennedy said.

Sen. Josh Hawley (R-Mo.) on Monday posted a letter from Makary to X, in which Makary wrote that he was “committed to conducting a review of mifepristone” alongside “the professional career scientists” at the FDA.

Makary said he could not provide additional information given ongoing litigation around the drug.

The states, in their 54-page petition, wrote that “no new scientific data has emerged since the FDA’s last regulatory actions that would alter the conclusion that mifepristone remains exceptionally safe and effective,” and that studies “that have frequently been cited to undermine mifepristone’s extensive safety record have been widely criticized, retracted, or both.”

Democrats have derided Kennedy’s efforts to reclassify mifepristone as politically motivated and baseless.

“This is yet 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 every person’s right to make their own medical decisions and help ensure that Mifepristone is available to those who need it.”

Bonta said Thursday that mifepristone’s placement under the FDA’s Risk Evaluation and Mitigation Strategy program for drugs with known, serious side effects — or REMS — was “medically unjustified,” unduly burdened patient access and placed “undue strain on the nation’s entire health system.”

He said mifepristone “allows people to get reproductive care as early as possible when it is safest, least expensive, and least invasive,” is “so safe that it presents lower risks of serious complications than taking Tylenol,” and that its long safety record “is backed by science and cannot be erased at the whim of the Trump Administration.”

The FDA has previously said that fewer than 0.5% of women who take the drug experience “serious adverse reactions,” and deaths are exceedingly rare.

The REMS program requires prescribers to add their names to national and local abortion provider lists, which can be a deterrent for doctors given safety threats, and pharmacies to comply with complex tracking, shipping and reporting requirements, which can be a deterrent to carrying the drug, Bonta said.

It also requires patients to sign forms in which they attest to wanting to “end [their] pregnancy,” which Bonta said can be a deterrent for women using the drug after a miscarriage — one of its common uses — or for those in states pursuing criminal penalties for women seeking certain abortion care.

Under federal law, REMS requirements must address a specific risk posed by a drug and cannot be “unduly burdensome” on patients, and the new application to mifepristone “fails to meet that standard,” Bonta said.

The states’ petition is not a lawsuit, but a regulatory request for the FDA to reverse course, the states said.

If the FDA will not do so nationwide, the four petitioning states asked that it “exercise its discretion to not enforce the requirements” in their states, which Bonta’s office said already have “robust state laws that ensure safe prescribing, rigorous informed consent, and professional accountability.”

June 4 (UPI) — Food and Drug Administration Commissioner Marty Makary said he plans to review the safety of abortion drug mifepristone after a recent study raised concerns about medical side effects.

In a letter to Sen. Josh Hawley, R-Mo., Makary revealed the FDA’s plan on Monday to review the abortion pill after Hawley alerted the commissioner to the study.

“As the Commissioner of Food and Drugs, I am committed to conducting a review of mifepristone and working with the professional career scientists at the agency who review this data,” Makary wrote.

“As with all drugs, FDA continues to closely monitor the postmarketing safety data on mifepristone for the medical termination of early pregnancy,” Makary added.

Hawley referred the FDA commissioner to the recent study, from the Ethics and Public Policy Center, which found 11% of women experienced sepsis, infection or hemorrhaging within 45 days of taking the pill.

While Hawley said that information is listed as a side effect for mifepristone, the numbers are 22 times greater than the label warns. The study was based on insurance claims for 865,727 mifepristone abortions between 2017 and 2023.

“I’m calling on the FDA to reinstate safety regulations on the chemical abortion drug immediately. New data out today show a massive number of severe medical side effects,” Hawley said in April. “The time to act is now.”

Makary told senators during his confirmation hearing in March that he would oversee a review of mifepristone, but did not order it until Hawley alerted him to the EPPC study. The FDA commissioner did express concerns earlier this year about the Biden administration’s policy, which allowed women to access abortion drugs without making in-person appointments.

Last year, the U.S. Supreme Court rejected a challenge to the FDA’s approval of mifepristone, saying the pro-life doctors who brought the case lacked standing. The court said the Alliance for Hippocratic Medicine failed to prove they suffered any harm from the FDA’s policies.

President Donald Trump, who supported the Supreme Court’s decision, was also urged by Hawley to order a mifepristone review over the EPPC’s findings.

BATON ROUGE, La. — A legal challenge against a first-of-its-kind measure that recategorized two widely used abortion-inducing drugs as “controlled dangerous substances” in Louisiana can move forward, a judge ruled Thursday.

Baton Rouge-based Judge Jewel Welch denied the Louisiana attorney general’s request to dismiss a lawsuit filed last year by opponents of the law, who argue that the reclassification of the pills is unconstitutional and could cause needless and potentially life-threatening delays in treatment during medical emergencies.

Attorneys for defendants in the suit, including Atty. Gen. Liz Murrill, argued that the lawsuit was premature. But attorneys for the plaintiffs, who include a doctor and pharmacist, said that since the law took effect in October, the measure has impacted how the plaintiffs handle and obtain the drugs on a “regular basis.”

A hearing date for the challenge has not yet been set.

Louisiana became the first state to heighten the classification of misoprostol and mifepristone, which have critical reproductive healthcare uses in addition to being used as a two-drug regimen to end pregnancies.

Passage of the measure by the GOP-dominated Legislature marked a new approach in conservative efforts to restrict access to abortion pills. In 2023, nearly two-thirds of all abortions in the country were medication abortions.

Now labeled as “Schedule IV drugs,” the pills are in the same category as the opioid tramadol and other substances that can be addictive. Under the new classification, there are more stringent storage requirements and extra steps to obtain the drugs. Testifying against the legislation, doctors stressed the drugs would be stored in locked containers or elsewhere that may result in slower access during emergency situations where every second is vital.

In the legal challenge, which was filed in October, plaintiffs say the law may slow access to “lifesaving treatment for people experiencing obstetrical emergencies” and make it “significantly harder” for people to “obtain proven, effective remedies necessary for their treatment and care.” Plaintiffs are asking the judge for a permanent injunction, ultimately to halt the law.

The legislation spawned from antiabortion groups and a Republican state senator’s effort to prevent coerced abortion and make it more difficult for bad actors to obtain the drugs. The lawmaker pointed to the case of his sister in Texas who in 2022 was slipped seven misoprostol pills by her husband without her knowledge; she and the baby survived. Over the past 15 years, news outlets have reported on similar cases — none in Louisiana — but the issue does not appear widespread.

“The Louisiana Legislature spoke loud and clear last year that they stand for life and are against this controlled substance being prescribed without a prescription from a doctor,” Murrill said ahead of the hearing.

Prior to the reclassification, a prescription was still needed to obtain mifepristone and misoprostol in Louisiana. Before the change, medical personnel told the Associated Press that in hospitals the drugs — which are also used to treat miscarriages, induce labor and stop bleeding — were often stored in an OB-GYN unit in a “hemorrhage box” in the room, on the delivery table or in a nurse’s pocket, to ensure almost-immediate access in common emergency situations.

With the heightened classification also comes increased charges. If someone knowingly possesses mifepristone or misoprostol without a valid prescription for any purpose, they could be fined up to $5,000 and sent to jail for one to five years. The law carves out protections for pregnant women who obtain the drug without a prescription to take on their own.

Other plaintiffs in the lawsuit include the Birthmark Doula Collective, an organization of people trained to provide pregnancy care before, during and after birth; Nancy Davis, a woman who was denied an abortion in Louisiana and traveled out of state for one after learning her fetus would not survive; and a woman who said she was turned away from two emergency rooms instead of being treated for a miscarriage.

Louisiana currently has one of the strictest abortion bans in the country, which includes abortions via medication.

Cline writes for the Associated Press.