Alaska Attorney Gen. Treg Taylor joined 21 attorneys general urging the federal government to press ahead with a review of the dangerous mail-in abortion drug mifepristone, and to reconsider reinstating safety protocols that were abruptly discarded by the Obama and Biden administrations.

In a July 31 letter, sent to U.S. Health Secretary Robert F. Kennedy and FDA Commissioner Martin Makary, the attorneys general noted that recent comprehensive studies of the real-world effects of the chemical abortion drug reveal that “serious adverse events occur 22 times more often than stated on the drug’s label, while the drug is less than half as effective as claimed.”

“These facts directly contradict the drug’s primary marketing message of ‘safe’ and ‘effective,’” the letter states. “Both of you are to be commended for taking this new information seriously and committing to conduct a full-scale review of mifepristone and its labeling based on objective data.”

The AGs urged the FDA to reinstate safety protocols that were removed by the Obama and Biden administrations.

If those protocols are not reinstated, the AGs urged Kennedy and Makary to withdraw mifepristone from the market altogether due to the “serious risks to women who are presently being prescribed this drug without crucial safeguards.”

The letter cites a large-scale study by the Ethics & Public Policy Center, published this past spring, which shows that mifepristone abortions result in serious adverse events for more than 1 in 10 women – 22 times the rate that currently appears on the drug’s label – and have a failure rate that is double the rate on the label.

EPPC’s report is based on a review of 2017–2023 data from an all-payer insurance claims database which included over 865,000 mifepristone abortions – the largest-known study of the abortion pill.

The EPPC Study analyzed diagnosis and procedure codes and used the official FDA definition of a serious adverse event to identify serious adverse events experienced by women prescribed mifepristone, which included sepsis, infection, hemorrhaging, surgical procedures after failed abortions, and complications from confirmed ectopic pregnancies.

“The EPPC Study appears more comprehensive than the clinical trials relied on by the FDA in 2016 when it approved label changes that removed most of the critical safeguards that had previously been included,” the AGs’ letter states.

It goes on to observe that the FDA removed “important safeguards” starting in 2016, which may “explain in part why the real-world risk of serious adverse events from 2017–2023 is so much higher than the risk identified in clinical trials cited in mifepristone’s label, which contained many of the safeguards that were later eliminated.”

The AGs then note that the original FDA-approval from 2000 required seven key safeguards due to the known dangers of the drug. This included three in-person office visits (day 1 administration of mifepristone; day 3 administration of misoprostol, the drug that completes the abortion; and day 14 visit to check for complications). It also limited the drug to unborn babies that were seven weeks gestation or less, and required a physician’s prescription with drugs being taken in a physician’s office.

“Yet, by the time the FDA implemented the current REMS in 2023, the FDA, under Presidents Obama and Biden, had increased the gestational age to 10 weeks and eliminated every other one of these requirements,” the letter warns. “Currently, a woman can obtain a mifepristone abortion by participating in only one telehealth visit with any approved healthcare provider (not necessarily a physician), ordering the drugs through a mail-order pharmacy, and self-administering them. And the prescriber is only required to report an adverse event if he or she becomes aware that the patient has died.”

The letter concludes by blasting the FDA’s removal of these crucial safety protocols in 2016 (and in 2023) that only five years before the FDA considered necessary.

This “begs the question of whether the removal was motivated by considerations other than the safety of patients,” the AGs said. “Now, the EPPC Study reports that in the years since the safeguards have been removed, the risk to women is far higher than was previously thought and far higher than the label indicates. The current FDA’s dedication to the health and wellbeing of all Americans is encouraging, as is the much-needed review of mifepristone that Secretary Kennedy has promised.”

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