Since the 1960s, the U.S. FDA has served as a model for drug regulation around the world with its stringent standards for approval of new drugs. Increasingly, however, a coalition of libertarians, patient advocates, and certain commercial interests have been pressing for a relaxation of these stringent standards. Examples of legislative initiatives that would weaken regulatory standards of evidence for drug approval include the “Regrow Act,” “21st Century Cures Act,” as well as various “Right to Try” laws passed in U.S. states.
Much has been written in support- and against- relaxation of current regulatory standards. Typically, these debates are framed in terms of a conflict between public welfare (i.e. the public needs to be protected from unproven and potentially dangerous drugs) and individual choice (i.e. desperately ill patients are entitled to make their own personal decisions about risky new drugs).
In a recent commentary, my co-author Alex London and I take a different tack on this debate. Rather than framing this as “public welfare” vs. “individual choice,” we examine the subtle ways that relaxed standards for drug approval would redistribute the burdens of uncertainty in ways that raise questions of fairness. We suggest weakened standards would shift greater burdens of uncertainty a) from advantaged populations to ones that are already suffer greater burdens from medical uncertainty; b) from research systems toward healthcare systems; c) from private and commercial payers toward public payers; and d) from comprehending and voluntary patients towards less comprehending and less voluntary patients. We hope our analysis stimulates a more probing discussion of the way regulatory standards determine how medical uncertainty is distributed.
The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.