Dozens of Democratic and Republican attorneys general are taking sides in a legal battle, the outcome of which will decide whether two widely used chemical abortion drugs may still be sold in the United States with federal approval.
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.
Dueling Coalitions
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.”
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.
FDA Response
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.