Rogers and Lynch Introduce Bill to Withdraw FDA Approval of High-Dose Narcotic Painkiller Zohydro ER
WASHINGTON, DC – Today, Congressman Stephen Lynch (D-MA), a co-chair of the Congressional Caucus on Prescription Drug Abuse, and Congressman Hal Rogers (R-KY), Chairman of the House Appropriations Committee and co-founder and co-chair of the Congressional Caucus on Prescription Drug Abuse, introduced the Act to Ban Zohydro. The bill seeks to withdraw approval for the high-dose narcotic painkiller Zohydro ER and prohibit the Food and Drug Administration (FDA) from approving such a drug in a formulation that is not abuse deterrent. The FDA’s recent approval of Zohydro ER against its own advisory panel’s recommendation highlighted the need for Congress to take immediate action.
The Anesthetic and Anagelsic Drug Products Advisory Committee, which is charged with advising the FDA on the safety and effectiveness of marketed and investigational human drug products, voted 11-2 against approving the drug without an abuse deterrent citing concerns over the potential for addiction. Substance abuse has been exacting a toll on America and the number of deaths reported by the Centers for Disease Control and Prevention (CDC) due to prescription drug abuse has spiked in recent years. According to the CDC, the number of deaths connected to prescription opioids has more than quadrupled in the United States from 4,030 deaths involving painkillers in 1999 to 16,651 deaths in 2010. Opioid based drugs were involved in 3 out 4 pharmaceutical overdose deaths in 2010. In 2014, the CDC has made it a top priority to reduce deaths attributable to prescription painkiller abuse.
“Zohydro ER is a high-dose hydrocone-only opioid narcotic painkiller that does not have an abuse deterrent formulation,” said Congressman Lynch. “Allowing access to a drug so powerful, without this critical component, creates risks for the public drug we simply cannot afford. The FDA recently has taken positive steps in the regulation of opioids, including reclassifying hydrocodone combination products such as Lortab and Vicodin to a more restrictive Schedule II drug and updating labeling requirements for all extended release/long acting (ER/LA) opioid analgesics. However, this is a giant step backwards at a critical time when prescription drug abuse has fast become a rampant problem across the nation. We cannot afford to allow yet another highly addictive opioid into the mainstream and potentially onto Main Street America.”
“While the FDA continues to send mixed signals to drug companies about the need to invest in abuse deterrent technologies, the Act to Ban Zohydro will make it abundantly clear – life saving measures are critical to the development of powerful painkillers like Zohydro,” said Congressman Rogers. “Someone dies every 16 minutes from a prescription drug overdose, making it the leading cause of accidental deaths in the United States. In southern and eastern Kentucky, we lost nearly an entire generation when crushable OxyContin was first prescribed, and I fear this crushable, pure hydrocodone pill will take us backwards with a new wave of addiction and tragic, untimely deaths. While there isn’t a silver bullet, abuse deterrent formulations offer common sense measures to curb the tide of overdose deaths in this country."
The Act to Ban Zohydro will take steps to reduce the proliferation of powerfully addictive opioid painkillers that lead so many Americans down the road to devastating substance abuse. Congressman Lynch and Congressman Rogers understand the needs of chronic pain sufferers; however, approving Zohydro ER without an abuse deterrent formulation puts our nation’s public health at a great risk due to the high likelihood for abuse.
In addition, 11 Members of the House of Representatives have signed on as original cosponsors of the bill. Today, Senator Joe Manchin introduced a companion bill in the Senate. Congressman Lynch and Congressman Rogers join in urging their colleagues to support this bipartisan, bicameral effort to stop another potentially harmful and highly addictive drug from being on the market.
The FDA’s approval of Zohydro ER will also be a highlighted topic during the 2014 National Rx Drug Abuse Summit in Atlanta, Georgia as leaders across the country discuss a holistic approach to the prescription drug abuse epidemic.
Click here to view the Act to Ban Zohydro.