(CNS News) -- The Alliance Defending Freedom has filed a lawsuit against the U. S. Food and Drug Administration (FDA), arguing that the agency failed to abide by its legal obligations “to protect the health, safety, and welfare of women and girls” when it authorized the use of chemical abortion drugs in the U.S. and “eliminated necessary safeguards for pregnant women and girls who undergo this dangerous drug regimen.”
The chemical abortion drugs specifically are mifepristone and misoprostol. According to doctors, they usually must be taken prior to the 11th week of pregnancy to ensure an abortion. Mifepristone is taken first and then, 24 hours later, 4 misoprostol pills are taken. Several hours later cramping and bleeding starts and the tiny baby is expelled from the uterus.
Currently, these abortion drugs can be delivered through the mail – as ordered by the Biden administration during the COVID pandemic – but this is a violation of federal law, according to the plaintiffs, who also charge that the FDA “never had the authority to approve these drugs for sale” in the first place.
The lawsuit was filed Nov. 18 in the U.S. District Court for the Northern District of Texas, Amarillo Division. The Alliance for Hippocratic Medicine, the American Association of Pro-Life Obstetricians and Gynecologists, the American College of Pediatricians and several other doctors are suing the FDA commissioner, other FDA officials, and Health and Human Services Secretary Xavier Becerra.
The Alliance for Hippocratic Medicine is a nonprofit membership organization that represents nearly 30,000 health-care professionals. The Alliance Defending Freedom (ADF) represents the plaintiffs.
In a statement about the case, the ADF said, “Part of the FDA’s mission is to be ‘responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices.’
“Unfortunately, for decades, the FDA has not been fulfilling this mission when it comes to its decisions about chemical abortion drugs. In 2000, the FDA approved chemical abortion drugs by running roughshod over the law and science. Since then, the agency has not followed the science, reversed course, or fixed its mistakes—to the detriment of women and girls. Instead, it has been dismantling the few safeguards that were in place when the drugs were originally approved.”
“This lawsuit is the culmination of decades-long efforts by ADF’s clients to hold the FDA accountable for its irresponsible actions,” said the legal firm. “The FDA approved chemical abortion drugs without basis and has spent decades removing what few protections were initially in place…. Women need to be able to trust medical professionals. The FDA’s approval of chemical abortion drugs under false pretenses and its decades of stonewalling legal challenges have broken that trust.”
Commenting on the case, SBA Pro-Life America President Marjorie Dannenfelser said, “First authorized in 2000 and expanded via mail-order under the pro-abortion Biden administration, abortion pills are swiftly becoming a leading health risk to mothers and babies. The FDA’s reckless lack of meaningful oversight has led to serious complications and a surge in emergency room visits for women using this drug regimen.” “Pregnancy is not an ‘illness’ as the FDA described in their creative justification to broadly distribute this dangerous pill.”
SBA Pro-Life America further said in a statement, “Multiple peer-reviewed studies confirm that women are at risk of severe side effects after taking chemical abortion pills, including hemorrhaging, the need for follow-up surgery, and even death. New Lozier Institute peer-reviewed research has found women are also twice as likely to be admitted for surgery if their abortion pill-related complications are miscoded by emergency room personnel as a natural miscarriage.”
Planned Parenthood praises the use of chemical abortion drugs. “Medication abortion is extremely effective in ending an early pregnancy, working approximately 95-99% of the time, and gives patients the option to end their pregnancy at home or in another setting in which they feel comfortable, while still providing them with the medical support and information they need,” said Planned Parenthood on its website.
“A growing number of patients in the United States are choosing to end their pregnancy with medication abortion,” said the nation’s largest abortion provider. “In fact, in 2014, nearly one in three people seeking abortion outside of a hospital used medication abortion.”
The lawsuit urges the judge to issue a preliminary and permanent injunction against the FDA to withdraw mifepristone and misoprostol as FDA-approved chemical abortion drugs. It also calls for the injunction to vacate FDA rules on chemical abortion pills that were implemented in 2000, 2016, 2019, and 2021.
The lawsuit also wants the court to “declare that the chemical abortion drugs mifepristone and misoprostol fall outside the scope of the FDA’s regulation entitled ‘Subpart H–Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses’ because pregnancy is not an ‘illness’ and these drugs do not ‘provide meaningful therapeutic benefit to patients over existing treatments.’”