The FDA has urged US District Judge Matthew Kacsmaryk to reject a preliminary injunction filed by abortion opponents to withdraw the approval for the drug used in medication-related abortions, according to court filings made available Tuesday.
The filings were submitted via a Nov. 2022 lawsuit brought in Texas by the American Association of Pro-Life Obstetricians and Gynecologists and other organizations.
The suit challenges the 2000 approval of the drug mifepristone, which when used with misoprostol, is approved to stop pregnancies within the first 10 weeks. Lawyers for those filing the suit also claim that the agency ignored the potential impact of the drug on minors and improperly used its accelerated approval authority to approve mifepristone.
In its bid for rejection of the preliminary injunction, the FDA said the request was “based on speculative allegations of harm” and that the arguments made were “untimely, unexhausted, and without merit.” The FDA also said that approving the injunction would cause harm by depriving people of a safe and approved drug.
There has been more focus on medical abortions after the June overturning of the landmark case Roe v. Wade. As of Oct. 2, 15 states have enforced total or up to 15-week abortion bans, according to the Guttmacher Institute while 44 states prohibit some abortions after a certain point in pregnancy.
“It would upend the status quo and the reliance interests of patients and doctors who depend on mifepristone, as well as businesses involved with mifepristone distribution,” lawyers for the FDA said in the filing to Kacsmaryk.
Mifepristone, manufactured by Danco Laboratories under the name Mifeprex, is the company’s sole product. On Jan. 3, the FDA said for the first time that mifepristone will be allowed to be dispensed at retail pharmacies. It is widely used by women seeking to end pregnancies medically versus surgically. Medical abortions accounted for 53% of all facility-based abortions in the US in 2020, according to the Guttmacher Institute.
Danco has also entered the fight, according to court documents filed on Jan. 13. Danco has requested the ability to intervene in the lawsuit to protect its ability to sell the drug and avoid going out of business.
“Forcing FDA to withdraw a longstanding approval would seismically disrupt the agency’s governing authority as to whether drugs are safe and effective, and would cause Danco direct and immediate harm by shuttering its business,” lawyers for the company wrote to the Trump-appointed judge in asking him to reject the preliminary injunction.
Lawyers for Danco took another shot at the filers’ argument that access to the drug caused irreparable harm.
“A third party’s use of a federally approved drug does not cause organizations or other providers ‘irreparable harm.’ That is all the more so when women have been able to lawfully access the drug for over 22 years,” the filing reads.
US Attorney General Merrick Garland made a point after the fall of Roe v. Wade to declare that states would not be able to ban the use of the abortion pill “based on disagreement with the FDA’s expert judgment about its safety and efficacy.”
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