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Federal Court Urged to Reverse FDA Approval of Abortion Pill

Federal Court Urged to Reverse FDA Approval of Abortion Pill

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 in a pregnancy, said in December 2021 it would make the policy change permanent.

Before that in 2016, the FDA 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 adverse complications, according to the Alliance Defending Freedom (ADF), which is representing the plaintiffs.

The agency has also 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 from three to one, 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 illegally approving dangerous chemical abortion drugs, FDA officials put women and girls in harm’s way, and now it’s high time they were held accountable for their reckless actions,” Baptist said in a statement ADF provided to The Epoch Times.

“Science was the FDA’s first victim. Women and girls were soon to follow. We urge the court to listen to the doctors we represent who are seeking to protect women from the documented dangers of chemical abortion drugs.”

Most Commonly Used Abortion Pill

The Mifepristone abortion pill is the most common means used to end pregnancies in the United States, according to the U.S. Centers for Disease Control and Prevention (CDC). A November 2022 CDC report said approximately 51 percent of abortions in 2020 were carried out using the pill at or before the ninth week of pregnancy. Pill abortions rose 22 percent from 2019 to 2020.

The FDA “has harmed women and girls by approving chemical abortion drugs and removing commonsense safeguards,” and in the process created “countless victims of this dangerous drug regimen,” according to the brief (pdf) ADF filed in the lawsuit on Feb. 10.

The FDA has “admitted … the agency never required or relied on a single study that evaluated the safety and effectiveness of these drugs under real-world conditions.”

“Without these vital studies, the harms that these drugs inflict on women are a heartbreaking, yet unsurprising, reality. The FDA also effectively conceded that its actions violated the plain letter of its regulations and federal laws.”

The FDA previously told Judge Matthew Kacsmaryk, a Trump appointee, that taking Mifepristone off the market would drive those who want abortions to obtain riskier, more invasive solutions such as surgical abortions, The Epoch Times reported.

“The public interest would be dramatically harmed by effectively withdrawing from the marketplace a safe and effective drug that has lawfully been on the market for twenty-two years,” the agency said in a brief.

States recently filed briefs with the court on both sides of the issue.

“Blocking access to this safe and effective medication is a dangerous attack on reproductive freedom and public health,” said New York Attorney General Letitia James, a Democrat, on behalf of 22 Democratic attorneys general. “Decades of medical and clinical research have proven that medication abortion is safe. Despite these facts and its widespread use, we know this is not a debate about science.”

Mississippi Attorney General Lynn Fitch, a Republican, countered on behalf of 22 Republican attorneys general, saying that Mifepristone is too easy to access.

“The serious nature of the FDA’s unlawful actions, and the agency’s decision to invite lawbreaking by private parties and government actors across the country, favors broad relief. The FDA and the [Biden] Administration as a whole have no intention to respect the Constitution, the Supreme Court, or the democratic process when it comes to abortion,” Fitch said.

The Epoch Times reached out to the FDA for comment but had not received a reply as of press time.

Naveen Athrappully contributed to this article.

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