FDA’s Change to Emergency Contraception Labeling Is Good News for Women
February 1, 2023 3 minutes read
In a move that expands access to contraception, the FDA announced on Dec. 23, 2022, that it was changing packaging labels for Plan B, the emergency contraceptive (EC) pill that is available over the counter. The EC’s box no longer will carry the baseless claim that the pill may prevent a fertilized egg from implanting in the womb.1,2
On the Plan B One-Step website, the consumer information now states that Plan B emergency contraception works by temporarily delaying ovulation, and it is a backup plan that will not affect a person’s ability to become pregnant later.1
The change will affect expanding reproductive rights in states like Idaho and Missouri, where some contraceptives already were under attack, based on ambiguous claims and uncertainty about their mechanism of action, says Chris ChoGlueck, PhD, an assistant professor of ethics and faculty advisor for Responsible Conduct of Research at New Mexico Institute of Mining and Technology in Socorro, NM.
ChoGlueck published a paper in February 2022, arguing for changing the label of levonorgestrel-based emergency contraception based on scientific evidence that it does not have a mechanism of action after fertilization.3,4
Misinformation about the mechanism of Plan B has contributed to anti-abortion advocates calling for bans on the pill. For example, in 2014, Hobby Lobby won the right to deny insurer-paid access to Plan B to employees, based on a corporation’s religious rights.5
The FDA’s decision is important in light of the 2022 Dobbs v. Jackson Women’s Health decision. “We’ve seen a lot of legal changes in states like Idaho, in particular, that has included Plan B in its bans for student health services,” ChoGlueck explains. “They include it as an abortifacient.”
A hospital in Missouri stopped dispensing Plan B because of the state’s abortion ban until the state’s attorney general clarified that EC is not included with the ban, ChoGlueck notes.
“In a lot of states, emergency contraception has this ambiguous status with abortion bans,” he says. “I think it’s important the FDA and drug sponsor have taken efforts to remove Plan B from its vulnerable status because having an incorrect status has made it vulnerable to being considered an abortifacient.”
The labeling change means states that enacted personhood laws have no FDA-label or scientific justification for including Plan B in their abortion bans. “The language on their website says there is no evidence to support saying Plan B has an effect after fertilization,” ChoGlueck says. “These changes by the FDA remove it from threats from other abortion legislation, so that’s all very good and is a really important move for increasing access and for reproductive liberty.”
The FDA’s decision changes the information included inside the Plan B box and on the drug’s website. It also takes the mechanism of action off the Plan B carton, which is consistent with the information presented on cartons for other medications. The change could help increase access to the over-the-counter medication in pharmacies, ChoGlueck adds.
With contraception also under threat, the FDA’s labeling change is a step in the direction of reproductive rights and access.
“It’s important to remove contraception from the gray area and make it squarely known that this is a contraceptive because this gray area is where there’s a lot of the battle right now,” ChoGlueck says. “It gives me a lot of faith that the FDA is willing to make moves that support reproductive freedom very broadly, and we really need that today because of the tide that we’ve already seen turn this past summer. We don’t know how far it’s going to go, and it’s already caused a lot of harm and will continue to cause harm.”
Every step in the direction of contraceptive access and reproductive freedom helps. “It might seem really small, but it’s a change in the face of so much misinformation out there that it gives us a little hope that the truth will shine through,” ChoGlueck says.
REFERENCES
- Plan B One-Step. How Plan B works. 2023.
- Seitz A. FDA changes Plan B label, clarifies it won’t cause abortion. AP News. Dec. 23, 2022.
- ChoGlueck C. The FDA ought to change Plan B’s label. Contraception 2022;106:6-9.
- Young M. Now is the time to change label on emergency contraceptives. Contraceptive Technology Update. June 1, 2022.
- Carey MA. Hobby Lobby ruling cuts into contraceptive mandate. NPR. June 30, 2014.
In a move that expands access to contraception, the FDA announced that it was changing packaging labels for Plan B, the emergency contraceptive pill that is available over the counter. The box no longer will carry the baseless claim that the pill may prevent a fertilized egg from implanting in the womb.
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