The attorneys general of Missouri, Idaho, and Kansas announced Monday that they are suing the Food and Drug Administration and the U.S. Department of Health, alleging that they did not have the legal right to approve abortion pills more than 20 years ago, and did not have the right to authorize the delivery of the pills through the mail during the Covid-19 pandemic.
The 105-page lawsuit, filed in U.S. District Court for the Northern District of Texas, is calling for a preliminary injunction against mail-order abortion pills, which it says assist “sex traffickers and sexual abusers to force their victims to get abortions” out of the view of authorities.
The lawsuit also calls for the reinstitution of safety precautions that were rolled back in 2016 and the reversal of the FDA’s 2019 approval of a generic version of the abortion pill.
The FDA “has a statutory responsibility to protect the health, safety, and welfare of all Americans by rejecting or limiting the use of drugs dangerous to the public,” the lawsuit says. “The FDA has failed in this responsibility. Specifically, it failed America’s women and girls when it chose politics over science and approved risky, untested chemical abortion drugs for use in the United States. And it has continued to fail them by turning a blind eye to these harms and repeatedly removing even the most basic precautionary requirements associated with the use of these risking drugs.”
The lawsuit from the three red states mirrors the lawsuit, Alliance for Hippocratic Medicine v. FDA, filed last year by the conservative legal firm, Alliance Defending Freedom. Missouri Attorney General Andrew Bailey has requested that the court combine the two suits.
Both lawsuits claim that the FDA never had the authority to approve the two-pill chemical-abortion regiment of mifepristone and misoprostol in 2000.
In 2016, the FDA increased the gestational age of the unborn baby when abortion drugs are allowed from seven weeks to ten, reduced the number of required office visits from three to one, allowed non-doctors to prescribe and administer the pills, and eliminated the requirement for prescribers to report nonfatal adverse events from chemical-abortion pills. And in 2021, during the coronavirus pandemic and after Joe Biden was elected president, the FDA announced that it would allow abortion pills to be dispensed through the mail.
In August, the Fifth Circuit Court of Appeals found that the challenge to the FDA’s 2000 approval of mifepristone is “likely barred by the statute of limitations,” but that the FDA went too far when it relaxed restrictions on the drug in 2016 and made the pills available through the mail in 2021. That ruling has had no immediate effect because the Supreme Court has issued a full legal stay in the case, preserving full access to the pills until all the appeals are played out.
To approve mifepristone in 2000, the FDA used its accelerated drug approval authority by classifying pregnancy as an “illness” and by arguing that abortion pills provide a “meaningful therapeutic benefit” over other methods, according to the latest lawsuit.
“Pregnancy is not an illness, and chemical abortion drugs do not provide a ‘therapeutic benefit’ over surgical abortion,” the lawsuit say. “The FDA never studied the safety of the chemical abortion drugs under the labeled conditions of use, despite being required to do so.”
The FDA and has instead “spent over two decades shamelessly flouting federal statutes and its own regulations,” the lawsuit says. “The FDA has never had the authority required to approve these drugs for sale to the public.”
Prior to filing the lawsuit, Bailey led a 20-state coalition warning pharmacies that following the FDA’s guidance on abortion pills is unlawful.
“Unelected federal bureaucrats do not have the statutory authority to approve the shipment of these dangerous chemical abortion drugs in the mail” Bailey said in a prepared statement. “The FDA’s guidance is not only unlawful, but would cost the lives of both women and their unborn children.”