MIFEPREX: New Report Reaffirms Safety of Medication Abortion Drug

A congressional watchdog agency affirmed the safety of one of the drugs used in medication abortion in a report issued Wednesday, saying the U.S. Food and Drug Administration (FDA) had properly conducted its revision of the drug labeling on Mifeprex.

The U.S. Government Accountability Office (GAO) report found the FDA followed a standard review process in 2016 when the agency revised the label on Mifeprex to say the drug could be used in abortions up to 70 days into pregnancy.

Patients take Mifeprex and another medication, misoprostol, to end an early pregnancy. The prior FDA label on Mifeprex said the drug could be used in abortions up to 49 days into pregnancy.

The GAO auditors found that the FDA reviewed the medical risks of Mifeprex, including 62 studies submitted from the drugmaker, Danco Laboratories, LLC, and “determined that the rates of certain adverse events remained stable and acceptably low.”

Approximately 3.2 million women took Mifeprex between September 2000 and June 30, 2017, the report noted. Among these, the FDA identified 20 deaths—a figure significantly lower than the maternal mortality rate.

The GAO interviewed pro- and anti-choice groups and medical organizations in preparing its report, including the American Congress of Obstetricians and Gynecologists, the American Association of Pro-Life Obstetricians and Gynecologists, the Bixby Center for Global Reproductive Health, and the Charlotte Lozier Institute.

Abortion providers had hailed the revised label for Mifeprex as affirming a protocol they said they’d found safe and effective in practice. Research in the peer-reviewed medical journal PLOS Medicine found the prior FDA labeling increased costs, caused more side effects, and reduced the number of medication abortions in Ohio by 80 percent between 2010 and 2014.

Abortion foes had opposed the label change. Eight Republican members of Congress, including Rep. Robert Aderholt (R-AL), chair of the House subcommittee overseeing the FDA, had asked the GAO to review the label revision by the FDA.

The American Civil Liberties Union (ACLU) said in a statement that Rep. Aderholt opposes abortion and has backed “medically baseless restrictions on abortion care throughout his career.”

“The GAO report confirms what reproductive health care providers and experts have known for two decades: The abortion pill is safe and effective,” Julia Kaye, staff attorney with the ACLU Reproductive Freedom Project, said in a statement.

The ACLU is suing to allow pharmacists to dispense abortion pills.
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