Overruling the Food and Drug Administration: An Analysis of the 2011 Denial of Over-the-Counter Status for Plan B Placed within the Historical Context of Executive Influence on FDA Action

Abstract

On December 7, 2011, newspaper headlines from coast to coast announced that Plan B One-Step, a form of emergency contraception, would not be made available to females under seventeen without a prescription. The denial of over-the-counter (“OTC”) status, though newsworthy itself, drew particular attention because of the unusual nature of the decision. As the New York Times announced, “[f]or the first time ever, the Health and Human Services secretary publicly overruled the Food and Drug Administration . . . . no health secretary had ever publicly done so . . . .”1 This paper analyzes the novel and much-discussed public overruling of the Food and Drug Administration Commissioner by the Secretary of Health and Human Services (“HHS”) regarding the prescription-only status of Plan B One-Step for women under seventeen. Part I begins by briefly detailing the history of emergency contraception from its creation through the new drug application process, court battles, and repeated efforts to obtain OTC status for Plan B. In Part II, I move forward in time to the most recent 2011 supplemental new drug application for Plan B and the subsequent December 7 decision, exploring in detail the declared reasoning of the FDA and HHS, the evidence presented, and the practical consequences of the decision for adolescent females. In Part III, I endeavor to place the overruling of the FDA in historical and legal context. Looking to the statements of former FDA employees, I explore reports of previous assertions of HHS authority over the FDA dating back to the 1950’s, and I review the legal source of that authority. Finally, I conclude by suggesting that the December 7 Plan-B decision, though unique in its public nature, was in fact consistent with a long history of behind-the-scenes HHS influence on FDA decisions. I also argue that the December 7 decision can be viewed as step towards more transparent agency decision making.