Congressional Letter Calls for Tougher Hydrocodone Restrictions

A group of lawmakers is urging the FDA to take prompt action to reclassify hydrocodone-based painkillers under tougher controlled substances laws, to help stem the continuing problems with abuse and fatal overdoses.

In a letter addressed to Margaret Hamburg, Commissioner of the FDA, eight members of Congress asked for the rescheduling of drugs containing hydrocodone from schedule III to schedule II classification.

The lawmakers are asking the FDA to “act without delay,” despite what many already consider a 14-year delay. A petition for rescheduling of hydrocodone drugs, such as Vicodin and Norco, was originally filed with the Drug Enforcement Administration (DEA) in 1999.

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“In those 14 years, there has been a staggering number of hydrocodone related deaths and a drastic increase non-medical users of these products,” wrote Senators Joe Manchin (D-W.Va), Jay Rockefeller (D-W.Va.), Mark Kirk (R-IL), Chuck Schumer (D-NY), Dianne Feinstein (D-CA) and Kirsten Gillibrand (D-NY), together with Representatives Ed Markey (D-MA) and Vern Buchanan (R-FL).

Advisory Committee Recommended Rescheduling

The FDA’s Drug Safety and Risk Management (DSaRM) advisory committee voted 19 to 10 last month in favor of the rescheduling hydrocodone pain killers.

The letter highlights the doubling of the number of recorded toxic exposures to hydrocodone. More than 24 million Americans are lifetime non-medical users of drugs like Vicodin, according to the National Survey on Drug Use and Health. The letter comes at a time when prescription medication abuse is at an all time high, with nearly 16,000 prescription painkiller overdose deaths in 2010 alone. More than that of cocaine and heroin combined.

“Hydrocodone drugs are some of the most commonly abused prescription drugs nationwide, and your own experts agreed it is time we take the necessary steps to address this deadly epidemic,” said the letter.

A schedule III drug is classified as having “moderate to low potential for physical or psychological dependence,” according to the DEA. A schedule II drug is known to have high potential for abuse.

Rescheduling hydrocodone drugs would allow fewer prescriptions to be written at one time and prohibit patients from receiving more than a three month prescription at a time.

Letter Calls for Protection for Pain Management Patients

The letter also addresses adequate access for patients with legitimate pain needs and ask the FDA to maintain protections for these patients, such as 90-day supplies refilled incrementally and emergency refill options.

Advocates call the rescheduling a “common sense decision” especially when considering the staggering popularity of Vicodin, Norco and other hydrocodone based drugs. Nearly 139 million prescriptions for hydrocodone were sold in 2010. It is the top selling controlled substance in the United States.

Other members of Congress who signed the bipartisan letter were Senator Jay Rockefeller (D-W.Va.), Senator Mark Kirk (R-IL), Senator Chuck Schumer (D-NY), Senator Dianne Feinstein (D-CA), Senator Kirsten Gillibrand (D-NY), Representative Ed Markey (D-MA) and Representative Vern Buchanan (R-FL).

The congressional petition follows a recent FDA advisory committee recommendation against the approval of a new hydrocodone based opioid drug, Zohydro ER. The pain relief drug was rejected by the committee citing its high risk of abuse, like other narcotic drugs such as oxycodone and methadone.


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