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Drug Facts and Value-Laden Labels: Contraceptive Controversy at the FDAWhen the U.S. Food & Drug Administration (FDA) makes a drug available over the counter, it has to decide how to inform users of the drug. However, the case becomes more complex and socially contested when the drug is a contraceptive, and the information is about abortion. The FDA stipulates and regulates what information pharmaceutical companies must include as “Drug Facts” on their packages, and the drug carton label itself is the primary means for the FDA and pharmaceutical company to inform patients about non-prescriptive drugs.
Plan B is a morning after pill, or emergency contraceptive, designed to be used after coitus in order to prevent an unwanted pregnancy. When the FDA approved this emergency contraceptive for over-the-counter sale in 2006, its drug facts included a curious piece of information: “this drug works mainly by preventing ovulation (egg release). It may also prevent fertilization of a released egg (joining of sperm and egg) or attachment of a fertilized egg to the uterus (implantation). See consumer information leaflet” (my italics). This is a curious case, for one, because this is the only instance of a mechanistic description given on a drug carton. In addition, this fact posits not only a primary mechanism, but also two secondary mechanisms that it describes in modal terms, as possibilities. What’s going on?
These exceptional and intriguing aspects of the drug fact beg a number of questions about the FDA’s practice of informing: (Q1) In what way is this drug fact informative (i.e., why does it matter)? (Q2) What is the evidence for this claim about possibility? (Q3) What are the social and political consequences of this information? To answer these three questions more fully, I provide a contextual analysis that looks at (1) the historical development of women’s health, (2) the evidential reasoning for this drug fact, and (3) the political stakes of this fact being authorized by the FDA.
My analysis takes the discussant through competing conceptions of women’s health, one rooted in liberal feminism and the other in Roman Catholicism, as well as disagreements over what counts as evidence for the potential effect of an abortion. Here, we see how evidential status and support is mediated by one’s view of women's health. I conclude with reflections on democratic pluralism at the FDA, which becomes especially important when, as I will argue, drug facts themselves are value-laden with ethical and ontological beliefs. I seek to engage discussants in the historical, scientific, and political aspects of the case, include this drug fact’s connection to the Sebelius v. Hobby Lobby Supreme Court case (2014). By attending to the function of background assumptions about women’s health, I will show these different conceptions have had influence both in medicine and the larger social context, e.g., the development of emergency contraception, the production of related knowledge, and the practice of medicine, including women’s treatment in emergency rooms and their contraceptive options under their insurance plans.
History and Philosophy of Science and Medicine
Indiana University Bloomington