Consumer group calls for FDA moratorium on opioid approvals

FDA should issue a moratorium on new opioid analgesic approvals, according to the advocacy group Public Citizen. In a letter to FDA Commissioner Scott Gottlieb and HHS Secretary Alex Azar, the group asserts that, along with the industry itself, "it is beyond question that the FDA is also culpable." The letter—signed by Sidney M.

FDA should issue a moratorium on new opioid analgesic approvals, according to the advocacy group Public Citizen. In a letter to FDA Commissioner Scott Gottlieb and HHS Secretary Alex Azar, the group asserts that, along with the industry itself, "it is beyond question that the FDA is also culpable." The letter—signed by Sidney M. Wolfe, founder and senior adviser to Public Citizen's Health Research Group, and Raeford E. Brown Jr., a University of Kentucky professor who is chairman of FDA's advisory committee on pain products—includes a petition to FDA to issue the moratorium. The letter notes that from 2009 to 2015, FDA approved more than two dozen new or reformulated opioid drugs. FDA said it would respond directly to the petitioners. Last month, Gottlieb said: "We've worked to learn from past mistakes, and we intend to make sure that we're acting forcefully enough to address new threats that could extend this crisis." Opioid drugs were involved in more than 47,000 overdose deaths in the United States in 2017, according to CDC estimates.