Calls for FDA Commissioner to Step Down Over Opioids

Anti-addiction advocates have sent a letter to Secretary of Health and Human Services Sylvia Burwell calling for FDA Commissioner Margaret Hamburg to step down.  The letter itself is worth reading.

I was in the audience at the National Prescription Drug Abuse Summit here in Atlanta back in April when Dr. Hamburg attempted to address some of the decisions the agency has made.  I can understand the tension created by the need to balance public health with the FDA's role of approving medications on which million upon millions of R&D dollars have been expended.  My view: it's not that she doesn't get it, it's that she's erring on the wrong side of the issue.  Public health concerns should be the primary lens through which her agency assesses new pain medications and that's simply not the case right now. 

The letter is signed by many organizations, most notably Physicians for Responsible Opioid Prescribing (PROP).  This organization has worked tirelessly to push back against the tide of prescription drug misuse and abuse and the regulatory system that enables it.  If you haven't seen or taken advantage of their education materials, you absolutely should.  Every person in medical and claims management can learn something about opioid abuse here: PROP web site. 

While I don't think Commissioner Hamburg will step down, the press coverage of the letter shines a spotlight on the issue and calls into question the behavior of the key federal regulatory agency responsible for approving new pain medications.  I think this will help push us toward a more comprehensive and responsible view of opioid prescribing.  

Michael
On Twitter @PRIUM1