Late last week, the conservative Alliance Defending Freedom filed suit in Amarillo, Texas, against the FDA, challenging the agency’s approval of the drug in the year 2000. The legal team arguing the case is the same one that challenged an earlier court’s 1973 Roe v. Wade decision that today’s court overturned in June.

In the 113-page complaint signed by four anti-abortion medical organizations and four physicians who have treated patients with the so-called “morning after” pill developed by former French drugmaker Roussel Uclaf the challengers named the Department of Health and Human Services (HHS) as a co-defendant.

In June, HHS said that drug retailers and wholesalers must continue to distribute Mifeprex as a Supreme Court decision is not a law and thus does not make the sale of abortion drugs illegal.

To get around the compliance order, the plaintiffs allege that the FDA “rushed” its original approval under a process that was foreseen to be used for life-threatening illnesses and had never studied the safety of the drugs under the labeled conditions of use.

Moreover, the lawsuit charges that the FDA exceeded its regulatory authority to approve the drug and never studied its safety under the labeled conditions of use.

Beyond this, the anti-abortion groups take issue with the FDA’s recent changes in the rules governing distribution of Mifeprex. Until 2021, the drug could only be prescribed in person and could not be sent by mail.

The health agency now allows video or phone consultations, although this is a moot point in the 19 US states that have outlawed telemedicine. Buyers who live in a state that allows abortions can also order Mifeprex online.

At present, 13 states ban abortion, including Texas. Six other states, even without a ban, prohibit distribution of the pill by mail. According to figures compiled by the New York Times, medication-induced abortion now account for more than half of the abortions in the US.

Author: Dede Williams, Freelance Journalist