Ten Miles Square

Blog

November 01, 2013 4:56 AM The FDA’s Mixed Signals on Pain Pill Policy

By Keith Humphreys

Prescription opioids like hydrocodone are remarkably useful for acute pain relief but are also capable of fomenting addiction and overdose. The most effective public policies regarding these medications keeps both of those realities in mind rather than yielding to an extreme anti- or pro-opioid stance. No federal government agency grapples with this challenge more than the Food and Drug Administration, and the evidence of the last week is that it has yet to come to an internal consensus on how to proceed.

First, the FDA recommended after years of study that hydrocodone combination products like Vicodin would be moved from Schedule III to the more restrictive Schedule II. This is a significant tightening of control over the most widely prescribed drugs in the U.S. (not just for pain, for anything). The impetus was the leading role of hydrocodone combination products in overdose deaths and emergency room admissions.

Yet 24 hours later, the FDA overruled its own expert panel and approved Zohydro, a pure hydrocodone pain medication that is 5 to 10 times more potent than Vicodin. In the process, FDA also overturned a precedent it had set only six months ago to not approve easily abused-opioids. After refusing in April to approve generic oxycontin because it lacked abuse-resistant properties, the FDA approved a drug whose full potency can be instantly released merely by crushing it or dropping it into alcohol (Get ready for a rash of Zohydro-cocktail deaths).

What the country needs on prescription opioids is carefully designed, balanced and consistent policy. What we are getting is policy that contradicts itself month-to-month and even day-to-day.

[Cross-posted at The Reality-Based Community]

Keith Humphreys is a professor of psychiatry and behavioral medicine at the Stanford University School of Medicine.

Comments

(You may use HTML tags for style)

comments powered by Disqus