Nancy Thai Nguyen1, Daniel M Cook2, Lisa A Bero3. 1. University of California, San Francisco, California, USA. 2. Department of Clinical Pharmacy, University of California, San Francisco, California, USA. 3. Department of Clinical Pharmacy and Institute for Health Policy Studies, University of California, San Francisco, California, USA. Electronic address: BeroL@pharmacy.ucsf.edu.
Abstract
BACKGROUND: The US Food and Drug Administration (FDA) and FDA advisory committees have been under increasing scrutiny as a result of media attention to safety concerns. OBJECTIVE: This article compares the decision-making process of the FDA's Nonprescription Drugs Advisory Committee (NDAC) in 3 cases of a proposed switch from prescription to over-the-counter (OTC) status involving a nicotine replacement therapy product, 2 statins, and an emergency oral contraceptive. METHODS: This comparative case study reviewed written transcripts and slides from 4 NDAC committee meetings and a digital video disc recording of a later meeting held to reconsider one of the proposed switches. The focus was on the committee's discussion and deliberation processes. Content analysis and iterative coding were used to assess the level of participation by committee members and the extent to which committee discussion adhered to both the key draft list questions provided by the FDA and the published DeLap criteria for switches from prescription to OTC status. Other major themes and discussion topics were identified, and the voting process was analyzed. RESULTS: In the absence of clearly defined meeting procedures, the advisory committees developed their own procedural standards. There were major differences between meetings in terms of the extent of discussion of the key draft list questions and adherence to the DeLap principles, discussion of other themes and topics, and voting methods. In each case, at least 1 major topic of discussion was not directly related to safety, efficacy, or self-use. Additional identified themes were the public health significance of a switch to OTC status, costs, and access. CONCLUSIONS: Variability in processes created discrepancies in the decision-making criteria used by the NDAC committees. There is a need to establish structured procedures to achieve an optimal level of uniformity and transparency in advisory committee processes.
BACKGROUND: The US Food and Drug Administration (FDA) and FDA advisory committees have been under increasing scrutiny as a result of media attention to safety concerns. OBJECTIVE: This article compares the decision-making process of the FDA's Nonprescription Drugs Advisory Committee (NDAC) in 3 cases of a proposed switch from prescription to over-the-counter (OTC) status involving a nicotine replacement therapy product, 2 statins, and an emergency oral contraceptive. METHODS: This comparative case study reviewed written transcripts and slides from 4 NDAC committee meetings and a digital video disc recording of a later meeting held to reconsider one of the proposed switches. The focus was on the committee's discussion and deliberation processes. Content analysis and iterative coding were used to assess the level of participation by committee members and the extent to which committee discussion adhered to both the key draft list questions provided by the FDA and the published DeLap criteria for switches from prescription to OTC status. Other major themes and discussion topics were identified, and the voting process was analyzed. RESULTS: In the absence of clearly defined meeting procedures, the advisory committees developed their own procedural standards. There were major differences between meetings in terms of the extent of discussion of the key draft list questions and adherence to the DeLap principles, discussion of other themes and topics, and voting methods. In each case, at least 1 major topic of discussion was not directly related to safety, efficacy, or self-use. Additional identified themes were the public health significance of a switch to OTC status, costs, and access. CONCLUSIONS: Variability in processes created discrepancies in the decision-making criteria used by the NDAC committees. There is a need to establish structured procedures to achieve an optimal level of uniformity and transparency in advisory committee processes.