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Preventing Prescription Opioid Abuse

Daniel A. Busch, MD1
[+] Author Affiliations
1Department of Psychiatry and Behavioral Sciences, Northwestern University Feinberg School of Medicine, Chicago, Illinois
JAMA. 2015;313(10):1059-1060. doi:10.1001/jama.2015.0518.
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To the Editor Although Dr Jones and colleagues1 claimed that the FDA regards “Preventing prescription opioid deaths [as] a public health priority,” this is not consistent with the FDA’s behavior. For example, the FDA instituted the untested, class-wide Risk Evaluation and Mitigation Strategy (REMS) program but continued to approve new extended release/long-acting (ER/LA) opioids with no evidence that the REMS actually reduces ER/LA opioid-related morbidity.

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March 10, 2015
Christopher M. Jones, PharmD, MPH; Peter Lurie, MD, MPH; Janet Woodcock, MD
1Office of the Commissioner, US Food and Drug Administration, Silver Spring, Maryland
2Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland
JAMA. 2015;313(10):1060-1061. doi:10.1001/jama.2015.0524.
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