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FDA 2013: A Study in Inconsistency

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Let's review the recent activities of the U.S. Food and Drug Administration in the area of prescription opioids.  If you're scratching your head as you read this, know that you won't be alone:

April 16, 2013:

The FDA announced two related decisions simultaneously.  First, they approved updated labeling (i.e., extended the patent for) Purdue Pharma's Oxycontin ER in light of its new abuse-deterrent formulation.  Second, the FDA determined that the original formulation of the same drug was pulled from the market in August of 2010 due to concerns about safety.  This means that the FDA will not accept or approve any generic forms of the original Oxycontin ER.  I wrote about this back in May.

This isn't great news for payers, but it's not the worst possible outcome.  Yes, we'll all be paying more for a patent-protected extended release opioid, but I've spoken to many that believe a cheap generic version of this same drug would have created more patient safety issues and more expensive claims over the long term. 

My view: Good news.

May 7, 2013:

The FDA approves the generic form of Opana ER, despite the fact that the maker of Opana, Endo Pharmaceuticals, had reformulated the drug with its own abuse-deterrent technology.  The FDA claimed the new formulation wasn't more likely to deter abuse than the original formulation.  Yes, extended release oxymorphone will be a lot cheaper.  But it will also be a lot easier to abuse, its street price will be attractive for those who might think of diverting medication, and the consequences (both clinical and financial) will be significant.

My view: I'm confused.

But wait, the message gets even more muddled...

Sept. 10, 2013:

The FDA announced label changes to extended release/long-acting opioids to indicate that these drugs are appropriate only for "the management of pain severe enough to require around the clock, long-term opioid treatment and for which alternative treatment options are inadequate."  The FDA also mandated label changes to include warnings to pregnant women and a requirement for additional post-market studies on drug safety.  While these changes are unlikely to impact prescribing behavior in the near term, they at least offered a signal from the government that the FDA understood the issue.

My view: Good news.

Oct. 24, 2013:

The FDA formally recommended that the Department of Health and Human Services tell the Drug Enforcement Agency to reclassify products containing hydrocodone from Schedule III to Schedule II, placing more controls on these drugs.  There are pros and cons to this recommendation and I've talked with many pharmacists who have legitimate concerns about patient access.  That said, the overwhelming consensus appears to be that patient safety and public safety demand that these drugs be more tightly controlled.

My view: More good news.

Oct. 25, 2013 (the very next day!):

The FDA announced the approval of Zohydro ER, an extended release form of hydrocodone that is likely to come in doses 5-10 times more powerful than existing products containing hydrocodone and which lacks any abuse-deterrent technology.  This approval comes over the objection of the FDA's own advisory panel, which voted in December (11-2) against the approval of the drug.  Further, the study methods used in the approval process were questionable, at best.

My view: Wait... what?

I'm certain the FDA holds the view that in each of these cases, the agency responded directly and objectively to the data that was presented.  But historical experience, public health data, and common sense tell us that the FDA still doesn't get it.

I wonder what 2014 will bring.

Michael Gavin is president of Prium, a medical cost-containment company located in Duluth, Ga. This column was reprinted with his permission from his Evidence Based blog.

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