The U.S. Food and Drug Administration (FDA) is asking a federal judge to reject a lawsuit seeking to withdraw the approval given to an abortion drug as plaintiffs accuse the agency of failing to follow proper regulatory standards and succumbing to political machinations during the approval process.
The lawsuit claims the drug poses an ongoing danger to women.
Mifepristone, available in a generic version and under the brand name Mifeprex, is used in conjunction with another drug for medication abortions within the first 10 weeks of pregnancy. In its court filing on Tuesday, the FDA insisted that there was no basis for second-guessing its original judgment from 2000.
Pulling mifepristone from the market will force abortion seekers to potentially undergo unnecessary and more invasive solutions like surgical abortions, the FDA stated. This can pose risks to some patients, like those who are intolerant to anesthesia.
“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,” FDA lawyers wrote in their filing to Judge Matthew Kacsmaryk in the U.S. District Court for the Northern District of Texas.
Attorneys from the Alliance Defending Freedom filed the lawsuit on behalf of the Alliance for Hippocratic Medicine, the American Association of Pro-Life Obstetricians and Gynecologists, Christian Medical & Dental Associations, the American College of Pediatricians, and four individuals.
Politics Behind Approval
The lawsuit insists that the FDA failed to protect American girls and women when it “chose politics over science and approved chemical abortion drugs” for use in the United States.In January 1993, President Bill Clinton asked his cabinet to legalize the use of chemical abortion drugs. At the time, mifepristone was manufactured by a French company.
Clinton and agency officials “pressured” the manufacturers to “donate for free” the U.S. patent rights of the drug to the Population Council, an entity focused on controlling population numbers, the lawsuit claims.
After receiving the patent rights, the Population Council “worked closely” with the Clinton administration’s FDA in the review process. The FDA approved mifepristone just a month before the closely-contested U.S. presidential election in 2000.
“The only way the FDA could have approved chemical abortion drugs was to use its accelerated drug approval authority, necessitating the FDA to call pregnancy an ‘illness’ and argue that these dangerous drugs provide a ‘meaningful therapeutic benefit’ over existing treatments,” the lawsuit states.
By asserting such “transparently false conclusions,” the FDA exceeded its regulatory authority to approve the drugs, the lawsuit states, adding that the agency did not study the drug’s safety under the labeled conditions of use despite being obligated to do so per the Federal Food, Drug, and Cosmetic Act.
Removing Drug Safeguards
In 2016, the FDA removed “crucial safeguards” to the chemical abortion drug regimen by expanding the gestational age limit for the procedure from seven weeks to 10 weeks, the complaint states.Those extra three weeks of fetal development pose an increased risk to the pregnant woman as the size of the baby and the surface area of the placenta have significantly grown during this time, the lawsuit states.
Also in 2016, the FDA changed the dosage and route of administering the chemical abortion drugs, cut the number of in-person visits required from three to one, eliminated a requirement to report nonfatal complications from such drugs, and expanded who could prescribe and administer the drugs beyond just medical doctors, the plaintiffs said.
All this was done without “any objective clinical investigations or studies that evaluated the safety and effectiveness of this new chemical abortion regimen or any safety assessment of its effects on the developing bodies of girls under 18 years of age,” the plaintffs argue.
In 2019, the FDA approved the generic version of the drug, mifepristone, again without any new clinical investigation evaluating the safety of the drugs, the lawsuit states.
In April 2021 after Biden took office, tbe FDA temporarily approved mail-order chemical abortions during the COVID-19 pandemic. In December 2021, the FDA made this measure permanent.
“After two decades of engaging the FDA to no avail, Plaintiffs now ask this Court to do what the FDA was and is legally required to do: protect women and girls by holding unlawful, setting aside, and vacating the FDA’s actions to approve chemical abortion drugs and eviscerate crucial safeguards for those who undergo this dangerous drug regimen,” the lawsuit states.
