Four Democrat-Led States Ask FDA to Lift Restrictions on Abortion Pill

Gizmodo

14 hours ago

The attorneys general of four Democrat-led states—New York, New Jersey, Massachusetts, and California—petitioned the Food and Drug Administration on Thursday, June 5, asking the agency to lift what they view as unnecessary restrictions on the abortion pill mifepristone.
The petition aims to force the FDA to acknowledge robust clinical evidence and decades of mifepristone use that support the drug's safety and efficacy. The move comes just one month after Health and Human Services Secretary Robert F. Kennedy Jr. told Congress that he ordered a safety review of the abortion pill. An FDA spokesperson confirmed plans for the review in a statement to CBS News on Tuesday, June 3.
According to the FDA, mifepristone, approved by the regulator in 2000, is a drug that blocks the hormone progesterone, which is necessary for pregnancy to continue. It is most commonly used in combination with the drug misoprostol to terminate a pregnancy within 10 weeks of gestation.
An analysis of 2023 data by the Guttmacher Institute found that medication abortions account for more than half (63%) of all abortions in the U.S. But in the years since the Supreme Court overturned Roe v. Wade, 17 states have banned this medication, and an additional 10 states have placed restrictions on it, according to the Washington Post.
'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,' California attorney general Rob Bonta told the Los Angeles Times.
The petition specifically asks the FDA to lift the mifepristone Risk Evaluation and Mitigation Strategy (REMS) Program. This additional regulatory framework is designed to 'help ensure the benefits of the medication outweigh its risks,' according to the FDA. REMS has been applied to 325 medications since its inception and currently applies to 71 drugs.
REMS places multiple restrictions on mifepristone use, including that prescribers be put on national and local abortion provider lists; patients give written statements that they intend to end their pregnancies; and pharmacies keep records of mifepristone prescribers and users. The attorneys general argue that these rules 'impose unnecessary and burdensome hurdles on patients, prescribers, pharmacists, and the healthcare system.'
They also point out that mifepristone has been marketed in the U.S. for decades and has been safely used by more than 7.5 million American women. 'Moreover, no new evidence raising safety concerns has emerged in the last two decades,' they state.
These states are not alone in their pursuit of expanded mifepristone access. Seventeen other Democratic-led or -leaning states, plus Washington D.C., are suing the FDA in Spokane, Washington, to loosen restrictions on the drug, Reuters reported in February. What's more, leading medical organizations have called on the FDA to remove REMS restrictions on mifepristone for years.
If the FDA declines to remove REMS, Thursday's petition asks the agency to 'exercise its discretion not to enforce' some or all of the restrictions in New York, New Jersey, Massachusetts, and California, as these states already place 'rigorous restrictions' around the practice of medicine.