Washington, DC- Today, U.S. Senators Jeff Merkley (D-OR), Barbara Mikulski (D-MD), and Joe Manchin (D-WV) announced a key win to help combat opioid abuse in the Senate Agriculture Appropriations bill that passed the Senate Appropriations Committee. The bill includes language that directs the Food and Drug Administration (FDA) to take into account the risk of addiction or overdose when reviewing new opioids and opioid marketing for approval, and to otherwise do more to reverse the opioid epidemic. The language also directs FDA to use expert advisory committees, responding to the FDA’s decision to approve OxyContin for children as young as 11 years old without consulting an expert advisory committee.
“Heroin and opioid addiction is devastating Oregon’s families. Doctors and nurses see the wreckage first hand, with patients pleading for help to get off pills. And here in Oregon seventy percent of heroin overdoses start with prescription pain pills,” said Senator Merkley. “We need to treat America’s and Oregon’s opioid epidemic as the national medical emergency it is, and this language included in the Senate Agriculture Appropriations bill will push the FDA towards action.”
“Heroin use and opioid abuse is ravaging and ripping apart our communities. In 2014, drug overdoses caused over 47,000 deaths in our country, including over 1,000 Marylanders,” Senator Mikulski said. “This legislation ensures the FDA will take concrete action through federal regulation of opioid medication to cut down on prescription drug overdoses and opioid abuse. As Vice Chairwoman of the Senate Appropriations Committee, I have fought and will continue fighting to put funds in the federal checkbook to combat opioid and heroin abuse in Maryland and across America.”
“The FDA must get serious about the dangers of prescription drugs, and this will not be accomplished without a significant change of culture at the agency,”Senator Manchin said. “The FDA’s number one priority must be the public’s health and well-being and language that I pushed to include in the FDA appropriations will ensure just that. The FDA needs to take into account the public’s health and seek the advice of its advisory committee’s when approving dangerous opioid medications. The FDA has taken steps to help curb this opioid abuse epidemic, but we must make sure the FDA is held accountable for its decisions and the impact they are having on the American people by fundamentally changing the way it approves harmful opioid medications.”
Between 2002 and 2013, the number of heroin-related deaths in America nearly quadrupled. Data from the Centers for Disease Control and Prevention (CDC) show that opioids — a class of drugs that include prescription pain medications and heroin — were involved in over 28,000 deaths in 2014.
The language included in the Agriculture Appropriations directs the FDA to continue implementing its opioids action plan announced in February 2016 to take concrete steps toward reducing the impact of opioid abuse on American families and communities, and to strongly consider the danger of addiction and overdose death associated with prescription opioid medications when approving and regulating the manufacturing, marketing and distribution of opioid medications. This plan should include policies aimed at reversing the epidemic while still providing patients access to effective pain relief.
The bill also directs the FDA to consult an expert advisory committee for any new opioid applications. In August of 2015, the FDA approved OxyContin for pain management in children as young as 11 years old, a decision much criticized, in part because FDA did not consult an expert advisory committee.
El proyecto de ley fue votado fuera del comité hoy en una votación bipartidista. Los próximos pasos serían que el proyecto de ley se envíe al pleno del Senado para una votación en el pleno del Senado y, finalmente, se fusione con un proyecto de ley homólogo de la Cámara de Representantes de los EE. UU. para que ambas cámaras lo aprueben y se convierta en ley.
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