Federal Court Urged to Reverse FDA Approval of Abortion Pill

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A group of national medical associations and doctors urged a federal court on Feb. 10 to order a federal regulator to reverse its two-decade-old approval of Mifepristone, a drug used for medication abortions that critics say endangers women who use it.

The abortion pill has become a focus of legal efforts by the pro-life movement since the Supreme Court overturned the 49-year-old Roe v. Wade precedent in June 2022, returning the regulation of abortion to the states, several of which have since banned or restricted abortions.

During the COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) temporarily lifted a requirement that women obtain the drug in person, allowing it to be mailed to consumers directly and purchased at pharmacies. The FDA, which has said Mifepristone is safe to use as late as the 10-week mark during a pregnancy, said in December 2021 it would make the policy change permanent.

Before that, the FDA in 2016 extended the permissible gestational age of the baby for which a girl or woman may take chemical abortion drugs—from 7 weeks gestation to 10 weeks gestation—which increased the mother’s risk of complications, according to the Alliance Defending Freedom (ADF), which is representing the plaintiffs.

The agency also has loosened policies governing the use of the abortion pill, such as altering the dosage and route of administration for the drugs, reducing the number of required in-person doctor visits to one from three, expanding who could prescribe and administer abortion drugs beyond medical doctors, and getting rid of the requirement for abortionists to report non-fatal complications from abortion drugs, ADF said.

The legal filing came in Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration, a lawsuit that was initiated in the U.S. District Court for the Northern District of Texas on Nov. 28, 2022.

In the legal action, the ADF is representing the Alliance for Hippocratic Medicine, the American Association of Pro-Life Obstetricians and Gynecologists, the American College of Pediatricians, the Christian Medical and Dental Associations, and four physicians.

The FDA needs to be held responsible for its bad decisions, according to Erik Baptist, senior counsel for the ADF.

By Matthew Vadum

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