FDA and Abuse Deterrent Opioids: Don’t fix the blame. Fix the problem

Peter J. Pitts

doi:10.5055/jom.2016.0346

Authors

Peter J. Pitts

DOI:

https://doi.org/10.5055/jom.2016.0346

Keywords:

FDA, Abuse Deterrent Opioids, chronic pain

Abstract

There is no such thing as a medicine that is 100 percent abuse-proof. The only abuse-proof medicine is one that is never prescribed—and for the hundreds of millions of Americans suffering from chronic pain that isn’t a viable option. Advancing the regulatory science of abuse deterrence is an important step in the right direction.

Author Biography

Peter J. Pitts

Peter J. Pitts, President, Center for Medicine in the Public Interest, New York, New York, former FDA Associate Commissioner.

References

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US Food and Drug Administration: 2015 Meeting Materials, Science Board to the FDA. Available at: http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/ScienceBoardtotheFoodandDrugAdministration/ucm431539.htm Accessed September 8, 2016.

Butler SF, Cassidy TA, Chilcoat H, et al.: Abuse rates and routes of administration of reformulated extended-release oxycodone: Initial findings from a sentinel surveillance sample of individuals assessed for substance abuse treatment. J Pain. 2013; 14(4): 351-358. Available at: http://www.jpain.org/article/S1526-5900(12)00803-6/fulltext Accessed September 8, 2016.

Dart RC, Surratt HL, Cicero TJ, et al.: Trends in opioid analgesic abuse and mortality in the United States. N Engl J Med. 2015; 372: 241-248. Available at: http://www.nejm.org/doi/pdf/10.1056/NEJMsa1406143 Accessed September 8, 2016.

Health Canada: Regulatory Update—Health Canada confirms proposed regulations requiring tamper resistance for Oxycodone will not move forward at this time. Available at http://news.gc.ca/web/article-en.do?nid=1045259 Accessed September 8, 2016.