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In the lawsuit, filed last November in the U.S. District Court in Northern Texas, conservative advocacy group Alliance for Hippocratic Medicine accused the U.S. Food and Drug Administration (FDA) of ignoring science and law to appease pro-abortion advocates when the agency evaluated and eventually approved mifepristone and misoprostol in 2000.
Specifically, the Alliance claimed that the FDA never studied the safety of those drugs under the labeled conditions of use, disregarded the potential negative effects the hormone-blocking regimen has on pregnant girls, and removed the few safeguards that were in place.
“The only way the FDA was able to approve the drugs was … by characterizing pregnancy as an ‘illness’ and arguing that these dangerous drugs provide a ‘meaningful therapeutic benefit’ over existing treatments,” the complaint (pdf) reads. “But pregnancy is not an illness, nor do chemical abortion drugs provide a therapeutic benefit over surgical abortion.”
Accounting for about half of all abortions in the United States, the combination of mifepristone and misoprostol remains the most common method to end pregnancy nationwide, according to a 2022 survey by pro-abortion research group the Guttermatch Institute.
With a new rule the FDA adopted in January, those who wish to get an abortion may order mifepristone from certified retail pharmacies by mail.
Democratic and Republican attorneys general have formed coalitions over the fate of mifepristone.
A coalition of 22 attorneys general, led by Democrat Letitia James of New York, on Friday asked the court to toss the case, claiming that withdrawing federal approval for mifepristone would block millions of people from getting “safe abortion care” and “miscarriage management.”
“The consequences of annulling the FDA’s approval of medication abortion—currently the most common method of obtaining early abortion—would be nothing short of catastrophic,” the Democrats stated in a brief (pdf) filed Friday, adding that taking the pills out of market will push millions of people to even more dangerous abortion methods.
Another coalition, also consisting of 22 attorneys general, is led by Republican Lynn Fitch of Mississippi. They are not only supporting the challenge, but are also seeking to terminate the new abortion pill-by-mail rule.
“Current federal criminal law plainly prohibits the distribution of abortion-inducing drugs through the mail,” Fitch said, citing the federal law that bans using mail to transfer obscene or crime-inciting matter.
“Even if the FDA’s approval of mifepristone harmonized with the agency’s own regulations and federal criminal law, those actions would not simply displace state laws regulating abortion,” the Republicans argued in their brief (pdf), also filed Friday. “States are entitled to enforce their duly enacted laws regulating chemical abortion in the interests of life, health, and safety.”
“The whole point of the Administration’s recent actions is to encourage and achieve evasion of those state laws,” they said.
In their response (pdf) filed last month, lawyers for the FDA argued that the case should be dismissed, since there is no precedent where a court has “second-guessed FDA’s safety and efficacy determination” and “ordered a widely available FDA-approved drug to be removed from the market.”
Moreover, a court decision to nullify FDA approval of a drug could harm the U.S. pharma industry and public health in the long run, the FDA’s legal team said.
“If longstanding FDA drug approvals were so easily enjoined, even decades after being issued, pharmaceutical companies would be unable to confidently rely on FDA approval decisions to develop the pharmaceutical-drug infrastructure that Americans depend on to treat a variety of health conditions,” they said.
The FDA lawyers also argued that the Alliance, which consists of individual physicians, simply lack the standing to sue. The Alliance, on the other hand, claimed that they do have third-party standing on behalf of their patients suffering from complications as result of chemical abortions.
The legal challenge also comes as major retail store chains are seeking certification to sell mifepristone in-person and by mail.
The nation’s two largest pharmacy chains, CVS and Walgreens, have said they are applying for certification and will sell mifepristone in states where the drug is legal. They cannot offer the pill in states that have revived their anti-abortion laws in the wake of the Supreme Court decision that overturned Roe v. Wade.
By Bill Pan