FDA Chief Criticizes Industry for Inaction on Opioids
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Monday, August 08, 2016 12:00 AM

The new head of the FDA accepted some blame for the agency’s role in the growing opioid epidemic, while also chiding drug manufacturers for failing to take action. “We are all sinners,” said FDA Commissioner Robert Califf, MD.  Califf spoke to provisional members of a newly formed committee charged with advising his agency on how best to balance the needs of legitimate pain patients with the societal issue of opioid addiction. Califf said he's spoken with R&D directors at most of the big drug companies and none have shown interest in investing in research on new non-addictive painkillers.

He told the committee that when it comes time to make recommendations, “I don't think corporate responsibility should be off your list of things to emphasize. There's a lot of money being made on opioids, and my view is if you make a lot of money on something, you do have some social responsibility for casualties of your success when they occur."

The guidance the committee develops is intended to update the 2011 Institute of Medicine report “Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research."  One committee member noted that the update is especially needed, since the words “addiction,” dependence," and "overdose" are nowhere to be found in the 2011 report.  In 2014, the CDC estimated there were 28,647 opioid-related deaths that year and that opioid overdoses had quadrupled since 2000.  Califf and his colleagues homed in on the issue of how to incorporate public health into a benefit-risk evaluation that has traditionally focused on the individual.

For comparison, he looked to the problem of antimicrobial resistance: “We're telling physicians to change their habits, not necessarily because it would have a devastating impact on the patient in front of them, but [because of] the impact it would have on the ecosystem."  The FDA is also changing labeling so that veterinarians can no longer prescribe antibiotics for animal feed without first examining the animals and giving a diagnosis.

The committee will hold a public workshop on Sept. 22, 2016.

 Source:  http://www.medpagetoday.com/Psychiatry/Addictions/58950