Commentary| Volume 106, P6-9, February 2022

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The FDA ought to change Plan B's label


      This commentary defends 3 arguments for changing the label of levonorgestrel-based emergency contraception (LNG EC) so that it no longer supports the possibility of a mechanism of action after fertilization. First, there is no direct scientific evidence confirming any postfertilization mechanisms. Second, despite the weight of evidence, there is still widespread public misunderstanding over the mechanism of LNG EC. Third, this FDA label is not a value-free claim, but instead it has functioned like a political tool for reducing contraceptive access. The label is laden with antiabortion values (even though EC is contraception, not abortion), and it imposes these values on potential users, resulting in barriers to access such as with Burwell v. Hobby Lobby. These 3 arguments together provide scientific, social, and ethical grounds for the FDA to take the initiate in changing Plan B's drug label.
      FDA (Food and Drug Administration), OTC (over-the-counter), LNG EC (levonorgestrel-based emergency contraception)


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      1. U.S. Government Accountability Office. Food and Drug Administration: Decision process to deny initial application for over-the-counter marketing of the emergency contraceptive drug Plan B was unusual.; 2005. [Accessed 25 November 2021].

      2. FDA. Center for Drug Evaluation and Research. Nonprescription Drugs Advisory Committee (NDAC) in joint session with the Advisory Committee for Reproductive Health Drugs (ACRHD). Meeting transcript. December 16, 2003.

        • Wynn LL
        • Trussell J.
        Images of American sexuality in debates over nonprescription access to emergency contraceptive pills.
        Obstet Gynecol. 2006; 108: 1272-1276
        • Wynn LL
        • Trussell J.
        The social life of emergency contraception in the United States: disciplining pharmaceutical use, disciplining sexuality, and constructing zygotic bodies.
        Med Anthropol Quart. 2006; 20: 297-320
        • ACOG Committee Opinion No 579: Definition of term pregnancy
        Obstet Gynecol. 2013; 122: 1139-1140
      3. Protection of human subjects. Code of Federal Regulations. 45 CFR 46. Subpart B. 46.202. Definitions.

        • Stanford JB
        • Hager WD
        • Crockett SA.
        The FDA, politics, and Plan B: To the Editor.
        NEJM. 2004; 350: 2413-2414
      4. FDA. Label, insert, and CARE program proposal for Plan B,; 2006 [accessed 18 June 2021].

        • ChoGlueck C.
        Drug facts, values, & the morning-after pill.
        Public Affairs Quart. 2021; 35: 51-82
        • Davidoff F
        • Trussell J.
        Plan B and the politics of doubt.
        JAMA. 2006; 296: 1775-1778
      5. 10th Cir. Appeal from the United States District Court for the Western District of Oklahoma (D.C. NO. 5:12-CV-01000-HE). 2013.

      6. Supreme Court of the United States. Syllabus: Burwell v. Hobby Lobby Stores; 2014 [accessed 18 June 2021].

        • ChoGlueck C.
        Broadening the scope of our understanding of mechanisms: lessons from the history of the morning-after pill.
        Synthese. 2019; 198: 2223-2252
      7. ChoGlueck C. Imposing values and enforcing gender through knowledge: Epistemic oppression with the morning-after pill's drug label. Hypatia, forthcoming.

        • Gemzell-Danielsson K
        • Berger C
        • Lalitkumar PGL.
        Emergency contraception — mechanisms of action.
        Contraception. 2013; 87: 300-308
      8. International Federation of Gynecology & Obstetrics, International Consortium for Emergency Contraception. Mechanism of action: how do levonorgestrel-only emergency contraceptive pills (LNG ECPs) prevent pregnancy?; 2012 [accessed 18 June 2021].

        • ACOG. Practice
        Bulletin No. 152: Emergency contraception.
        Obstet Gynecol. 2015; 126: e1-11
      9. Haute Autorite de Sante. NorLevo Reneweal Of Registration, June 3, 2015.; 2015 [accessed 18 June 2021].

        • Kahlenborn C
        • Peck R
        • Severs WB.
        Mechanism of action of levonorgestrel emergency contraception.
        The Linacre Quarterly. 2015; 82: 18-33
        • Mozzanega B
        • Nardelli GB.
        UPA and LNG in emergency contraception: the information by EMA and the scientific evidences indicate a prevalent anti-implantation effect.
        Eur J Contracept Reprod Health Care. 2019; 24: 4-10
        • Peck R
        • Rella W
        • Tudela J
        • Aznar J
        • Mozzanega B.
        Does levonorgestrel emergency contraceptive have a post-fertilization effect? A review of its mechanism of action.
        Linacre Q. 2016; 83: 35-51
        • Cataldo PJ.
        Moral certitude in the use of levonorgestrel for the treatment of sexual assault survivors.
        (editor)in: Eberl JT Contemporary controversies in Catholic bioethics. Springer International Publishing, Cham2017: 197-222
        • Austriaco NPG. Is Plan B an abortifacient? The National Catholic
        Bioethics Quart. 2007; 7: 703-707
        • Cleland K
        • Marcantonio TL
        • Hunt ME
        • Jozkowski KN.
        “It prevents a fertilized egg from attaching…and causes a miscarriage of the baby”: A qualitative assessment of how people understand the mechanism of action of emergency contraceptive pills.
        Contraception. 2021; 103: 408-413
        • Silva FC da
        • Vitalle MS de S
        • Maranhão H de S
        • Canuto MHA
        • Pires MM de S
        • Fisberg M
        Diferenças regionais de conhecimento, opinião e uso de contraceptivo de emergência entre universitários brasileiros de cursos da área de saúde.
        Cad Saúde Pública. 2010; 26: 1821-1831
        • Monteiro DLM
        • Pereira MFVR
        • Herter LD
        • Avila R
        • Raupp RM.
        Emergency hormonal contraception in adolescence.
        Rev Assoc Med Bras. 2020; 66: 472-478
        • Nappi RE
        • Lobo Abascal P
        • Mansour D
        • Rabe T
        • Shojai R
        For the Emergency Contraception Study Group. Use of and attitudes towards emergency contraception: A survey of women in five European countries.
        Eur J Contracep Reprod Health Care. 2014; 19: 93-101
        • Aksu H
        • Küçük M
        • Karaöz B
        • Ünay V.
        Knowledge, practices, and barriers concerning the use of emergency contraception among women of reproductive age at a university hospital of Aydin, Turkey.
        Arch Gynecol Obstet. 2010; 282: 285-292
        • Willetts SJ
        • MacDougall M
        • ST Cameron
        A survey regarding acceptability of oral emergency contraception according to the posited mechanism of action.
        Contraception. 2017; 96: 81-88
        • Eastham R
        • Milligan C
        • Limmer M.
        Qualitative findings about stigma as a barrier to contraception use: the case of emergency hormonal contraception in Britain and implications for future contraceptive interventions.
        Eur J Contracep Reprod Health Care. 2020; 25: 334-338
        • Bhansali AH
        • Fleming ML
        • Sherer JT
        • Sansgiry SS.
        Improving information processing: the effect of label format among current and potential over-the-counter medication users.
        Therap Innov Regulat Sci. 2016; 50: 560-568
        • Rapkin RB
        • Griner SB
        • Godcharles CL
        • Vamos CA
        • Neelamegam M
        • Thompson EL
        • et al.
        Obstetrics and gynecology and family medicine residents’ training and knowledge on emergency contraception.
        J Women's Health. 2019; 28: 794-801
        • Lee CJ
        • Ahonen K
        • Apling M
        • Bork C.
        Emergency contraception knowledge among nurse practitioner students: emergency contraception knowledge.
        J Am Acad Nurse Pract. 2012; 24: 604-611
        • Faundes A
        • Osis MJ
        • Sousa MH
        • Duarte GA
        • Miranda L
        • Oliveira W.
        Physicians’ information to patients and prescription of the emergency contraceptive pill according to their personal experience of using the method and perception of its mechanism of action.
        Eur J Contracept Reprod Health Care. 2016; 21: 176-182
        • Chiarello E.
        How organizational context affects bioethical decision-making: pharmacists’ management of gatekeeping processes in retail and hospital settings.
        Soc Sci Med. 2013; 98: 319-329
        • Fiala C
        • Arthur JH.
        “Dishonourable disobedience” – Why refusal to treat in reproductive healthcare is not conscientious objection.
        Woman - Psychosom Gynaecol Obstet. 2014; 1: 12-23
        • McLeod C.
        Harm or mere inconvenience? Denying women emergency contraception.
        Hypatia. 2010; 25: 11-30
        • Yang C.
        The inequity of conscientious objection: refusal of emergency contraception.
        Nurs Ethics. 2020; 27: 1408-1417