Tuesday, July 10, 2012

FDA Plan on Opioids: Good News? Or Bad?

Today brought a tale of two headlines.  Business Insurance declared "FDA Approves Plan to Fight Growing Opioid Abuse" while the New York Times declared "FDA Won't Order Doctors to Get Pain-Drug Training."  Turns out, they're both right.

The FDA on Monday adopted the Risk Evaluation and Mitigation Strategy that has been debated, discussed, and deliberated for several years.   The plan requires manufacturers of prescription opioids to, among other things, create and distribute physician and patient educational materials.  That's not exactly a solution unto itself, but it does represent progress (and at least tacit acknowledgment on the part of the pharmaceutical industry that the misuse and abuse of prescription painkillers has become a national health crisis). 

The controversial nature of the FDA announcement is driven largely by what is absent from the plan - mandatory physician training on the topic of safe opioid prescribing.  In 2010, the FDA's own advisory panel rejected the notion that this plan should include "voluntary physician education," instead recommending that the such education should be mandatory.  But the FDA has chosen to punt to Congress on this issue.  The NY Times indicates that the FDA commissioner is "hopeful that Congress would eventually enact mandatory physician training." 

In principle, I think this position is dangerous and not in keeping with the severity of the issue we face as a society.  Pragmatically, however, I'm not certain the FDA has the authority (or perhaps more importantly, the enforcement capabilities) to create rules around mandatory physician education.

State medical boards and/or (I can't believe I'm writing this...) the US Congress need to step in and create both the mandate for physician training around opioid prescribing as well as the consequences for non-participation.  This is more complicated than it might seem, but certainly a policy step necessary to stem the tide of opioid misuse and abuse.

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1 comment:

  1. Let's not also note the article in USA today titled, “Opana abuse in USA overtakes OxyContin”. A lot of bad news as I see it. The FDA REMS (Risk Evaluation Mitigation Strategy) to make OxyContin safe is that when you try to crush the tablet (one of the main ways to abuse this otherwise long-acting drug), it turns into a gooey gel. I've been assured by some of the young drug abusers I treat that there are ways to adulterate the preparation - but that Roxicet and Opana are better to use.
    Prescribers need training to know that opioids don't work for chronic pain very well - this education is an imperative arm of reducing the epidemic of opioid abuse and overdose deaths.
    I agree, that the FDA doesn't have ability to enforce, but let's make doctors responsible for this education and worry about enforcement later if nothing changes. Meanwhile, people's lives are ruined by intractable dependence on these potent drugs.
    Mel Pohl, M.D. mpohl@centralrecovery.com