CommentaryThe FDA ought to change Plan B's label
Section snippets
Background
Fifteen years ago, when the US Food and Drug Administration (FDA) initially approved over-the-counter (OTC) sale of Plan B (albeit with an age restriction), it was a cause for celebration among advocates of contraceptive access. Since 2003, the Bush Administration had delayed the switch to OTC status of this levonorgestrel-based emergency contraceptive (LNG EC), exerting a top-down influence in an “unusual” decision process [1]. In addition to concerns about the use among young adolescents and
Argument 1: Lack of scientific support for postfertilization mechanisms
There are a variety of potential mechanisms of action for any postcoital form of contraception, including effects on ovulation, fertilization and sperm functioning, embryo development/transport, and endometrial receptivity and implantation. The only well confirmed mechanism for LNG EC is the suppression of ovulation within a very narrow window of effect [15], [16], [17]. When administered prior to ovulation, LNG EC delays development of the leading follicle (which releases the mature egg) by
Argument 2: Widespread public misunderstanding about EC mechanisms
Because of the lack of scientific support for a postfertilization mechanism, the current Plan B label spreads misinformation to potential users and the general public. According to a recent US-based survey, while nearly half of respondents did correctly attribute prefertilization mechanisms to EC, most participants (61%) incorrectly described postfertilization/preimplantation mechanisms [24]. Furthermore, a substantial portion (9%) conflated preventative EC with medication abortion, which does
Argument 3: Value-laden information imposes values and burdens on potential users
The third reason for changing this label involves the relation of ethics and science. The original decision to add this description of the mechanism to Plan B's label was not value-free. Instead, as I have shown elsewhere, it was premised on the ethical values and political goals of antiabortion appointees who aimed to protect zygotes from alleged harm, ultimately limiting women's agency and access (even in cases of sexual assault) [9]. Antiabortion science advisers at the FDA advocated for
Concluding remarks
The FDA label is just one threat among many to EC access and reproductive justice more broadly. Nonetheless, if we see the current FDA label as it truly is—scientifically outdated misinformation that can function as a political tool for reducing contraceptive access—then we ought to seriously consider the prospects of changing it. Evidenced by the US Hobby Lobby case and present proceedings in Peru, the potential for injustice based on this label is immense.
Declaration of Competing Interest
The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
Funding
This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.
Acknowledgments
I thank Kelly Cleland and Lisa Lloyd for their detailed comments on this paper, as well as the helpful reports from 3 anonymous referees and the editors of the journal. I am also indebted to Cristina Puig Borràs and Gabriela J. Oporto Patroni for information about the legal barriers to access in Peru and to David Turok for information about IUD EC.
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