October 24, 2013

Manchin Applauds FDA for Rescheduling Hydrocodone to Curb Prescription Drug Abuse

Announcement comes 9 months after Manchin testified before the FDA’s Advisory Committee

Washington, D.C. – After years of fighting in the United States Senate to help curb the nation’s prescription drug abuse epidemic, U.S. Senator Joe Manchin (D-W.Va.) expressed his appreciation today after Department of Health and Human Services (HHS) Secretary Sebelius informed Senator Manchin that the Food and Drug Administration (FDA) will recommend rescheduling hydrocodone combination drugs from a Schedule III to a Schedule II controlled substance. Hydrocodone is a highly addictive substance found in drugs like Vicodin and Lortab.

Today, the FDA has officially recommended that HHS reschedule hydrocodone from a Schedule III to a Schedule II controlled substance. HHS is expected to pass along this recommendation to the Drug Enforcement Administration (DEA), which will immediately begin the reclassification process. 

“Today was a tremendous step forward in fighting the prescription drug abuse epidemic that has ravaged West Virginia and our country,” Senator Manchin said. “Rescheduling hydrocodone from a Schedule III to a Schedule II drug will help prevent these highly addictive drugs from getting into the wrong hands and devastating families and communities. I want to sincerely thank my good friend Senator Tom Harkin from Iowa for being so helpful in making this possible. I am also extremely grateful that the Food and Drug Administration has finally implemented its own advisory committee’s recommendations to reclassify these addictive drugs. The agency has just saved hundreds of thousands of lives.”

“While we recognize that a legitimate need for pain management exists, we also realize that the diversion of prescription pain medication for illegal purposes is one of the biggest problems we face in West Virginia,” said West Virginia State Police Colonel C. R. “Jay” Smithers. “The reclassification of hydrocodone is a major step toward restoring accountability and oversight between medical providers and patients suffering from acute injuries, chronic pain and terminal illness. I would like to thank Senator Manchin, the United States Congress, the United States Drug Enforcement Administration, and the Federal Drug Administration for proactively taking a major step toward addressing the issue of prescription drug diversion not only here in West Virginia, but nationwide. It is my sincere belief that this measure will decrease the amount of hydrocodone available to those who do not possess a legitimate prescription.”


• 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.

• 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.

• 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. 

• 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.

• 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.

• 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.