Lawmakers press FDA for action on addictive painkillers

Lawmakers asked the FDA for a specific timeline on how quickly hydrocodone medications could be taken from a Schedule III drug to a Schedule II, which would make them harder to get. 

“The American people have waited too long for action from this agency,” the lawmakers wrote in a letter to the FDA. “Your own experts agreed it is time we take the necessary steps to address this deadly epidemic.”

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Reps. Vern Buchanan (R-Fla.) and Edward Markey (D-Mass.) signed the letter, along with Sens. Joe Manchin (D-W.Va.), Mark Kirk (R-Ill.), John Rockefeller (D-W.Va.), Charles Schumer (D-N.Y.) and Kirsten Gillibrand (D-N.Y.).

The lawmakers noted that the number of chronic abusers of hydrocodone in the U.S. has increased to more than 24 million since 1999, when Congress originally asked the agencies to work on the issue. 

“It has been 14 years since the initial petition requesting that the FDA and [the Drug Enforcement Agency] evaluate the proper scheduling of hydrocodone combination drugs. In those 14 years, there has been a staggering number of hydrocodone related deaths and a drastic increase in non-medical users of these products,” lawmakers wrote.

Moving hydrocodone combination drugs from a Schedule III to a Schedule II classification would make a doctor’s written prescription mandatory to obtain the medications, among other restrictions.  

Lawmakers said 139 million prescriptions of hydrocodone-based painkillers have been sold since 2010, making them the top-selling controlled substance in America.

The FDA announced it would move to address the availability of the drugs last month, following a 19-10 vote by an advisory panel that agreed new restrictions are needed.