Four Pro-Choice States Petition FDA to Lift Mifepristone Restrictions

As the Food and Drug Administration undertakes a full agency review of the safety of the chemical abortion drug mifepristone, four pro-abortion attorneys general are asking the FDA to reverse course and lift all remaining restrictions on the drug.

“We will never waver in our support for reproductive freedom, and we will not stand by while the Trump Administration threatens access to essential reproductive health care,” New Jersey Attorney General Matthew Platkin said. “Federal restrictions on mifepristone are burdensome impediments to reproductive choice and are not based in science or medicine. The FDA has an opportunity to do the right thing and to eliminate barriers to access to this critical medication.”

Mifepristone is the first of a two-pill regimen for medical abortion, used up to 12 weeks of pregnancy. The drug blocks a hormone necessary for the survival of the fetus. Mifepristone is then followed by misoprostol, which stimulates contractions similar to natural miscarriage.

The petition, filed by the attorneys general of California, Massachusetts, New Jersey, and New York, asks the FDA to fully lift the current risk evaluation and mitigation strategy program, known as the Mifepristone REMS Program. The REMS program requires a certification process for prescribers of mifepristone and pharmacies that carry the drug, in addition to a patient agreement form that affirms the patient intends to end her pregnancy.

Alternatively, the petition asks the FDA not to enforce REM restrictions on the drug for prescribers practicing in the petitioning states. It argues the states already impose sufficient protections to ensure patient safety.

The petition comes as FDA Commissioner Marty Makary promises a full agency review of the safety of the drug. The petitioners are urging the FDA to use the full review of mifepristone to lift remaining restrictions and maximize access to the medication, according to a press release from Platkin’s office.

“For decades, medication abortion has been recognized not only as effective, but so safe that it presents lower risks of serious complications than taking Tylenol or getting a colonoscopy,” Attorney General of California Rob Bonta said in a statement. “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.”

The petition openly casts doubt on a recent study on the safety of mifepristone from the conservative Ethics and Public Policy Center, calling it “retrospective” and “scientifically flawed.” The think tank’s study found almost 11 percent of women experience a serious adverse effect within 45 days following mifepristone abortion, a rate 22 times higher than the current label indicates.

Ethics and Public Policy Center president and author of the report Ryan T. Anderson told National Review when the Trump FDA conducts its own comprehensive review of the safety of mifepristone and examines the insurance claims data, it will find exactly what the study suggests.

"Our studies revealed both the alarming rate of serious adverse events from the abortion pill and its startling failure rate," Anderson said. "We are glad to see that the FDA has also recognized how troubling this data is and announced that they will be conducting their own review of the drug. Over the last few decades, the abortion industry has tactically moved to eliminate every remaining safety protection associated with mifepristone, unfortunately American women have tragically been forced to pay the price."

The attorneys general also rejected studies funded by the pro-life Charlotte Lozier Institute indicating the widespread occurrence of abortion coercion in connection with mifepristone, alleging the studies contain “serious methodological flaws.”

“Given mifepristone’s 25-year safety record, there is simply no scientific or medical reason to subject it to such extraordinary restrictions,” New York Attorney General Leticia James said in a press release. “New Yorkers, and all Americans, deserve access to this safe, effective, and essential medication without burdensome, unjustified restrictions. The FDA must follow the science and lift these unnecessary barriers that put patients at risk and push providers out of care.”

The Supreme Court last year rejected a challenge to the FDA’s approval of mifepristone, ruling the pro-life doctors who brought the case lacked standing. Several lawsuits seeking the removal of REMS restrictions are currently pending against the FDA.