April 29, 2014

Manchin Submits Formal Recommendation to Reschedule Hydrocodone During DEA Comment Period

Washington, D.C. – Yesterday, U.S. Senator Joe Manchin (D-W.Va.) submitted a public comment to the Drug Enforcement Administration (DEA) encouraging the agency to reschedule hydrocodone-combination drugs, which are found in highly addictive painkillers like Vicodin and Lortab, from a Schedule III to a Schedule II controlled substance.

The DEA is the lead federal agency in enforcing narcotics and controlled substances laws and regulations, however, before any proposed rule such as rescheduling hydrocodone becomes law, it is published in the Federal Register. Then, a public comment period of 30 days begins to allow the public to submit written comments to the agency.

Please read Senator Manchin’s public comment to the Drug Enforcement Administration below:

Prescription drug abuse is ravaging my great state of West Virginia and our nation.  Last year alone, almost 17,000 Americans died from prescription drug overdoses, and West Virginia had the highest per capita rate of overdose in the nation.  The vast majority -- almost 75% -- of these deaths came at the hands of opioids, like hydrocodone.  It's high time we act to stop this preventable epidemic, and I am pleased the Food and Drug Administration (FDA) and Drug Enforcement Agency (DEA) have finally answered the call of duty.  By recommending rescheduling hydrocodone combination drugs from a Schedule III drug to a Schedule II drug, the FDA has helped saved hundreds of thousands of lives, and the DEA should follow suit by implementing that recommendation as quickly as possible.
Since I was Governor of West Virginia, I have fought tirelessly to stem the tide of prescription drug overdose deaths and I've continued that fight from my first day as a United States Senator.  Although I faced obstacles at every turn, the call from my people necessitated continued action.  After writing numerous letters, demanding action from agency officials, and even testifying before the FDA, I was so pleased to hear the FDA finally recommend rescheduling in October of 2013.
Of course, the FDA and the DEA had been alerted to the need for rescheduling 15 years ago in a petition filed with the DEA.  Since that rescheduling petition was originally filed in 1999, the lifetime non-medical users of hydrocodone have also more than doubled – and currently exceed 24 million Americans. Hydrocodone combination products are currently the top selling controlled substance in the United States by far, with over 139 million prescriptions sold in 2010 alone.  We must address this epidemic before it gets even stronger.
The FDA took almost a decade and a half to hold a Drug Safety and Risk Management (DSaRM) Advisory Committee hearing to publicly discuss the appropriateness of rescheduling hydrocodone combination drugs, a hearing at which I testified to explain the effects of these drugs on my constituents. The Advisory Committee responded with a resounding 19 to 10 vote in favor of rescheduling hydrocodone combination products. The message could not be more clear: these drugs must be rescheduled.
The American people have waited too long for action. In the 15 years since the initial petition requesting rescheduling, a staggering number of individuals have died at the hands of hydrocodone and countless families have been devastated.
I understand that many stakeholders express concerns regarding adequate access to pain medication for legitimate pain patients. I share these concerns, and urge the agency to maintain the specific protections for legitimate pain patients already in place for all Schedule II drugs, including 90-day supplies that must be filled incrementally and emergency refill options. I truly believe that these regulations protect patient access and foster a healthy and supportive patient-doctor relationship.
Again, rescheduling hydrocodone combination drugs would be a tremendous step forward in the fight to curb the prescription drug abuse epidemic that has ravaged West Virginia and our country. It will help prevent these highly addictive drugs from getting into the wrong hands and devastating families and communities.  I thank the FDA for recommending rescheduling, and I urge the DEA to move quickly in finalizing its regulations so that we are able to save hundreds of thousands of lives. 


o May 2012 – Senator Manchin included an amendment to the Food and Drug Administration Safety and Innovation Act to reschedule hydrocodone. The measure passed by unanimous consent in the Senate.

o June 2012 – Senator Manchin urged negotiators of a House-Senate compromise of the Food and Drug Administration Safety and Innovation Act to support the amendment, however it was not included in the version of the bill passed in the House of Representatives.

o October 2012 – When Senator Manchin’s measure was omitted in the final piece of legislation that was signed into law, he requested that the Food and Drug Administration hold a Drug Safety and Risk Management Advisory Committee hearing, which advises the FDA on the abuse potential of drugs and makes recommendations about how they should be controlled. 

o January 25, 2013 – The FDA’s own advisory committee voted 19-10 to reclassify the highly addictive drug on the same day that Senator Manchin testified at its committee hearing. Senator Manchin shared several stories from West Virginians who have struggled with hydrocodone addictions or family members whose loved ones overdosed on these painkillers.

o March 20, 2013 – Senator Manchin sponsored the “Safe Prescribing Act,” along with Senator Mark Kirk (R-IL), and Representatives Vern Buchanan (R-FL) and Ed Markey (D-MA), to reclassify hydrocodone painkillers. The bipartisan, bicameral legislation received widespread support from Democrats and Republicans in both legislative chambers, as well as from health care providers, addiction specialists, law enforcement, advocacy groups and victims across the nation.

o After allotting time for the FDA to implement its own committee’s recommendations to reschedule the drug, Senator Manchin sent three letters to FDA Commissioner Margaret Hamburg urging the agency to immediately take action.

o October 24, 2013 – The Department of Health and Human Services (HHS) Secretary Sebelius informed Senator Manchin in October that the Food and Drug Administration (FDA) would recommend rescheduling hydrocodone combination drugs from a Schedule III to a Schedule II controlled substance.