Additionally, though the FDA has now approved Opill, the Associated Press reported in May that the administration had concerns about the reliability of some of Perrigo’s data on the drug. AP also reported that the FDA “questioned whether women with certain other medical conditions would correctly opt out of taking it” and “also noted signs that study participants had trouble understanding the labeling instructions.”
The FDA approved Opill in July nonetheless. Perrigo says that the drug will be available in stores across the U.S. and online “early in the first quarter of 2024.”
This comes as the pending FDA v. AHM lawsuit concerning a different pill called “mifepristone,” which is used as an abortifacient, continues to work its way through the courts.
In this case, the Alliance for Hippocratic Medicine and several other pro-life organizations being represented by the Alliance Defending Freedom are suing the FDA for its mifepristone approval.
According to the Alliance Defending Freedom, the FDA failed to protect the health and safety of women and girls by “illegally approving chemical abortion drugs” after having “never studied the safety of the drugs under the labeled conditions of use” and overlooking “the potential impacts of the hormone-blocking regimen on the developing bodies of adolescent girls.”
On April 7 U.S. District Court Judge Matthew Kacsmaryk overturned the FDA’s mifepristone approval, effectively banning its use in the U.S. However, the Biden administration’s request for the ruling to be temporarily blocked pending their appeals was granted by the U.S. Supreme Court. For now, mifepristone remains legal while the case is argued in the Fifth Circuit Court of Appeals.
Contraceptive pills advocacy group Free the Pill Coalition applauded the FDA’s approval of Opill in a Thursday press release, calling it a cause for celebration, “especially in light of the ongoing attacks on reproductive health and rights.”
“We will continue our critical work to advocate at the federal and state levels to expand insurance coverage of OTC [over the counter] birth control pills and ensure everyone who wants to can walk into their local pharmacy and pick up a pack of birth control pills right off the shelf,” Free the Pill said in its press release.
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