FDA Prematurely Relabels Plan B
Image by RODNAE Productions.
By Colten Maertens-Pizzo
In episodes 106 and 107 of Bioethics on Air, “Changing the Messaging and Mechanisms of Plan B,” Joe Zalot interviews John Brehany, director of institutional relations at The National Catholic Bioethics Center, regarding the revised messaging for Plan B, which was published by the US Food and Drug Administration (FDA) on December 23, 2022 and stated that the medication “will not affect an existing pregnancy.” Brehany explains that this label change may be premature and elaborates on the moral challenge that will result from this revision.
Plan B is the brand name for levonorgestrel, a progesterone mimic that has been marketed since 1999. It is widely used as an emergency contraceptive. According to Brehany, sexual assault protocols normatively use Plan B for pregnancy prevention. It is usually one of the first drugs used “up to one hundred and twenty hours after a sexual assault” (ep. 106, 6:52). The exact mechanism of Plan B has never been clear, which the FDA acknowledged prior to the label change. The agency recognized three possible mechanisms: (1) delaying or suppressing ovulation, (2) inhibiting the movement of sperm, and (3) preventing implantation.
On December 23, 2022, the FDA removed the second and third possible mechanisms from Plan B’s label. Brehany argues that this action is overly hasty and brings with it ethical concerns. Although there are many ethical issues with providing Plan B to victims of sexual assault, he focuses the conversation on two problems that hinge upon the drug’s exact function. First, there is the question of whether the drug truly protects “the bodily integrity” and “the dignity of the victim of sexual assault.” Second, if it acts as an abortifacient, then it violates “the life and human dignity of any child who is conceived as a result of a sexual assault” (ep. 106, 7:41, 8:25).
The Catholic Church currently allows the use of drugs that prevent pregnancy from sexual assault, provided they do not act as an abortifacient. Quoting from the Ethical and Religious Directives of Catholic Health Service, which have been approved by the Congregation for the Doctrine of the Faith, Brehany says, “A female who has been raped should be able to defend herself against a potential conception from the sexual assault.” However, he clearly explains that the Church takes care to affirm the dignity of human life once conceived: “When you take a drug accepting … the consequence that … it may prevent the coming to be of new life [but] it may also end early life, you are guilty of an abortion” (ep. 106, 16:08).
Brehany explains throughout the interview that Plan B may act as an abortifacient and that the FDA previously acknowledged this possibility. He criticizes the agency for going out of its way, as he describes it, to now reverse course (ep. 106, 21:06). In 2006 and 2009, the FDA had opportunities to reverse its previous stance, but “both times they refused to take that action” (ep. 106, 23:49). The agency currently claims to have thoroughly evaluated all evidence to date and determined that Plan B does not act as an abortifacient. Brehany claims this logic is flawed, if not at least overly hasty.
According to Brehany, not much has changed research wise for understanding the mechanism of Plan B (although there is some important new information about Plan B’s lack of effect on sperm and implantation). He admits that the “FDA was able to engage some studies and resolve some questions” (ep. 106, 31:25). However, it failed to clearly demonstrate that Plan B has only the one mechanism of inhibiting or delaying ovulation.
There is good evidence that timing matters for the effectiveness of Plan B for preventing ovulation. If it is administered, for example, one to two days before expected ovulation, then there is only an 8 percent chance that it will in fact prevent ovulation. Yet, if given five days before ovulation, then there is a 90 percent chance to prevent ovulation: “What they’re not addressing … right in front of their eyes” is “that it really matters relative to ovulation when you give it” (ep. 106, 37:40).
In addition, there is evidence from 2010 and 2011 that Plan B has some measure of abortifacient activity. Brehany refers to a study by Gabriela Noé and colleagues, which included women who were engaging in sexual activity during their fertile windows to assess the effect of Plan B on ovulation. It found that women who had sexual intercourse and ovulated had no pregnancies despite confirmation that they had ovulated. As Brehany notes, “You would think maybe there would be some pregnancies” (ep. 106, 42:10). The fact that there were no pregnancies suggests that something significant is going on.
Brehany explains that the FDA has not taken these studies and their findings seriously—for political reasons. He suspects the agency reacted to the leaked draft opinion of Dobbs v. Jackson Women’s Health in spring 2022. He fears that as an immediate consequence, various institutions will do “away with any limitations that exist on the use of Plan B” and encourage its usage (ep. 107, 8:03).
According to Brehany, the FDA’s revision adds to a debate in Catholic health care that began in the early 1990s. The first part of the debate regards the accuracy of our understanding of the biochemistry of rape protocol regimens. Given one to two days before ovulation—when Plan B is known to be less effective at preventing ovulation—women do not get pregnant. This poses a serious doubt, which Catholic hospitals must now account for in their rape protocols.
The second part of the debate regards the moral certainty that emerges precisely from our understanding of Plan B’s biochemistry: “What’s the standard when we have some doubt about the right course of action?” (ep.107, 17:20). The Church teaches that, when facing moral uncertainty, one must work to exclude reasonable doubt. If the doubt cannot be excluded, then the action in question remains impermissible. Therefore, Catholic institutions should not give Plan B within the window when there is doubt about whether the drug will prevent ovulation or hinder implantation: “It can't do the good thing we want it to do,” and “there is some reason to believe it would do something we shouldn’t be doing” (ep. 107, 26:30).
Some Catholics worry that the FDA will make similar label changes to Ella, a progesterone blocker that acts “right as a woman's body detects that a newly conceived human being is there” and undermines progesterone activity on cellular action necessary for maintaining pregnancy (ep. 107, 31:50). Brehany shares these worries, recognizing a political movement to conflate the biochemistry of the many different drugs: “There has been a lot of effort to get across the point, ‘This works just like Plan B’” (ep. 107, 34:32).
Tragically, Plan B and Ella are not the only drugs whose biochemistry the FDA may revise, and there is reason to believe that it may attempt another revision. Doubts arise, for example, about the future labeling of the abortifacient mifepristone as the pro-choice movement sues the FDA overs its current labeling and regulation. It is clear that policymakers with influence over the FDA are pushing it to relabel contraceptives and abortifacients for easier access, regardless of the evidence. The heart of the FDA’s recent actions, as Brehany explains throughout both interviews, stems from pro-choice politics’ reaching into medical science. Because of this influence, the “FDA didn’t take the time to settle the issue” (ep. 107, 52:55).
Click here for the NCBC’s statement “FDA Change of Plan B One-Step Label: Points to Consider.”
Colten Maertens-Pizzo works for the Archdiocese of Chicago Catholic School System.