May 10 2013
WASHINGTON, DC - Today, U.S. Rep. Harold "Hal" Rogers (KY-05) issued the following statement about the U.S. Food and Drug Administration's (FDA) decision to leave the powerful painkiller, Opana Extended-Release Tablets (Opana ER) on the U.S. market for "reasons of safety or effectiveness." The decision allows generic versions of the original, easily-abused painkiller to be sold.
“I’m disappointed that the FDA is allowing cheap crushable pain pills to stay on the market in the United States," said Rogers who co-founded the Congressional Caucus on Prescription Drug Abuse. "These powerful drugs have caused far too many overdoses and deaths around the country when misused, and in Kentucky, they have proved to be a gateway drug for heroin abuse. The bottom line is that we need better technology to deter tampering and abuse of prescription meds to fix our country’s pain pill addiction, and the sooner we can incentivize the development and approval of safer, tamper-resistant pills, the better we all will be.”
The FDA was required to respond to a petition from the drug manufacturer, Endo Pharmaceuticals, seeking an abuse-deterrent label for Opana ER on Friday, May 10, 2013. The federal agency's response was also due for a Citizen's Petition to keep the original drug off the shelves. In a personal phone call to Congressman Rogers on Friday, FDA Commissioner Dr. Peggy Hamburg explained the agency did not have the authority to pull the original Opana ER off the market at this time.
Last month, Congressman Rogers applauded the FDA and Dr. Hamburg for blocking the original, crushable OxyContin from returning to U.S. markets on April 16, 2013. During the National Rx Drug Abuse Summit in Orlando, Florida April 2-4, 2013, Rogers and Dr. Hamburg spoke privately and publicly about the prescription drug abuse epidemic and their concerns for opioids that do not contain abuse-deterrent measures. Rogers told the nearly 1,000 Summit attendees that Congress was prepared to act if the FDA failed to do so. Four drug-related bills in the U.S. House include the Safe Prescribing Act (H.R. 1285), the Stop Oxy Abuse Act (H.R. 1366), the Stop Tampering of Prescription Pills (STOPP) Act (H.R. 486), and the Prescription Drug Abuse Prevention and Treatment Act (H.R. 672).
The prescription drug abuse epidemic now claims more American lives than car crashes. Rogers also joined a bipartisan group of members in introducing H.Res. 161 last month, expressing the Sense of the House of Representatives that the FDA should require generic versions of abuse-deterrent painkillers to use comparable abuse-deterrent features.
In 2009, Rogers joined former Representative Mary Bono Mack to form the Congressional Caucus on Prescription Drug Abuse. Rogers has served Kentucky’s 5th Congressional District since 1981. With a focus on economic development, job creation, fighting illegal drugs and preserving Appalachia’s natural treasures, he has a reputation for listening to his constituents and fighting for the region he represents. For more information, visit http://halrogers.house.gov or follow Rogers on Twitter and Facebook.