Letter to the Food and Drug Administration (FDA) Commissioner Margaret Hamburg - Fight to Curb Prescription Drug Abuse

Letter

U.S. Senators Joe Manchin, Jay Rockefeller (both D-W.Va.) and Members of Congress sent a bipartisan letter to the Commissioner of the Food and Drug Administration (FDA) today to urge immediate action on rescheduling drugs containing hydrocodone to help combat the prescription drug abuse epidemic, as recommended by the FDA's own advisory board. The letter emphasizes that the FDA has exceeded the "reasonable time" requirement of the Controlled Substances Act.

The bipartisan, bicameral group of Congress continues to fight to tighten restrictions on some of the most powerful, addictive narcotics on the market. Rescheduling hydrocodone painkillers, such as Vicodin and Lortab, from a Schedule III to a Schedule II controlled substance, would accurately reflect the drugs' high potential for addiction and abuse. The FDA advisory board has already completed a review and accepted the recommendation to reschedule the drug. However, the agency has yet to act.

The Members of Congress asserted, "It has been 14 years since the initial petition requesting that the FDA and Drug Enforcement Administration evaluate the proper scheduling of hydrocodone combination drugs. Not only is 14 years more than enough time, but this rescheduling process has exceeded the "reasonable time' requirement of the Controlled Substances Act. Your own advisory board has already approved rescheduling by a 19 to 10 vote. The American people have waited too long for action from this agency."

The letter was also signed by Mark Kirk (R-IL), Chuck Schumer (D-NY), Dianne Feinstein (D-CA), Kirsten Gillibrand (D-NY), Bill Nelson (D-FL), Marco Rubio (R-FL) and Representative Vern Buchanan (R-FL).

Below is the letter sent to Commissioner Margaret Hamburg:

Dear Commissioner Hamburg:

Thank you for your March 14, 2013 response letter regarding a citizen's petition to reschedule hydrocodone. While we appreciate your reply, we remain concerned about the already excessive length of time that this rescheduling process has taken. We are also disappointed that you did not provide the requested timeline for reaching a final decision regarding rescheduling hydrocodone combination drugs.

The Centers for Disease Control (CDC) have labeled the prescription drug problem ravaging our nation as an "epidemic." Recent CDC data underscores the role that opioid pain relievers, like hydrocodone combination products, play in unintentional overdose deaths. Its study demonstrated that drug overdose deaths increased for eleven straight years since 1999. Sixty percent of the drug overdose deaths (22,134) involved pharmaceutical drug products. Prescription drug products containing oxycodone, hydrocodone, methadone and others, represented three-quarters of those deaths (16,651).[1] A separate, independent analysis of autopsy reports from various coroners' offices between 2006 to 2011 conducted by the Los Angeles Times shed additional light on the role that hydrocodone plays in overdose deaths. Its analysis of 3,733 prescription drug-related fatalities in Southern California found that hydrocodone was involved in over a quarter of the deaths, more than any other prescription medication.[2]

This information underscores the scope and magnitude of the hydrocodone abuse epidemic and why we believe that it is imperative that the FDA complete its review and accept the recommendation of its Drug Safety and Risk Management Advisory Committee (DSaRM).

The Controlled Substances Act (CSA) requires that the:

"Evaluation and the recommendations of the Secretary […] be made in writing and submitted to the Attorney General within a reasonable time." 21 U.S.C. §811(b) [emphasis added]

It has been 14 years since the initial petition requesting that the FDA and the Drug Enforcement Administration (DEA) evaluate the proper scheduling of hydrocodone combination drugs. Not only is 14 years more than enough time, but this rescheduling process has exceeded the "reasonable time" requirement of the CSA. Your own advisory board has already approved rescheduling by a 19 to 10 vote. The American people have waited too long for action from this agency. Your previous response failed to address our request for a timeline for finalizing your review and, accordingly, we are writing a second time to respectfully request a timeline of this 14-year petition.

Let us again emphasize that rescheduling hydrocodone combination products from Schedule III to Schedule II is an important step in addressing prescription drug abuse. We respectfully urge you to accept the recommendation made by the DSaRM Advisory Committee without delay, and we look forward to your response.

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