Congress Orders FDA to Reclassify Pain Killers – Now

Congress Orders FDA to Reclassify Pain Killers – Now

February 18th, 2013 // 6:12 pm @

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One month after an FDA advisory panel voted 19-to-10 to place Vicodin and other prescription painkillers that contain hydrocodone under greater restrictions, a bipartisan group of members of Congress have written the FDA to demand the agency take “swift action” to follow the recommendation and produce a timeline for doing so.

And in their letter, they note it has been 14 years since the FDA was first asked to reclassify prescription painkillers containing hydrocodone, such as Vicodin. “The American people have waited too long for action from this agency,” they wrote to FDA commish Margaret Hamburg.

At issue is an increasing effort to find a midpoint that balances patient needs for pain relief with ongoing concerns over abuse and addiction associated with these medications. The recent FDA panel meeting was held at the request of the US Drug Enforcement Agency, which maintains these drugs need to be more tightly controlled.

As we previously reported, a 2010 report from the US Centers for Disease Control and Prevention noted that the rise in overdose deaths in the US paralleled a 300 percent increase since 1999 in the sale of prescription painkillers. The drugs were involved in 14,800 overdose deaths in 2008, more than cocaine and heroin combined.

Currently, painkillers that contain hydrocodone are listed as Schedule III drugs, which are defined as having a high potential for abuse, and could lead to severe psychological or physical dependence. These drugs are also considered dangerous (read more here).

If the FDA were to reclassify the drugs to Schedule II, the change would mean fewer prescriptions could be written at one time, and patients seeking Vicodin could only get up to three months of prescriptions instead of six months under current DEA scheduling.

The letter was sent by two US Senators from West Virginia – John Rockefeller and Joe Manchin, both of whom are Democrats; US Senator Diane Feinstein, a California Democrat; US Senator Kirsten Gillibrand, a New York Democrat; Congressman Ed Markey, a Massachusetts Democrat and Vern Buchanan, a Republican congressman from Florida


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