Peter J. Pitts
President, Center for Medicine in the Public Interest

DOI:https://doi.org/10.5912/jcb657


Abstract:

Google “opioid abuse deterrence” and you’ll find a lot of hits from lawyers and elected officials. What you won’t find is a lot of expert thinking from the FDA.

That needs to change. FDA Commissioner Hamburg’s March 13, 2014 testimony in front of the Senate HELP Committee) hopefully represent a more aggressive stance by the agency. That’s good. But there needs to be more. The FDA must be the leading voice on the issue of abuse deterrence and the safe use of opioids.

At present, politicians and pundits (not to mention trial lawyers) own the conversation. They're the ones talking about it. They're the ones the media goes to when they write about it. Have a look at a sampling of the press coverage surrounding Zohydro and see who's quoted and what they're saying.

The struggle over control of the opioid abuse deterrence story is, shall say, not going the right way for the FDA.

Keywords:opioids ,FDA ,safety ,innovation ,regulatory policy ,DEA ,pain ,en ,