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CLAAD Petitions FDA To Reject Opioid Medications Without Safety Features
Date:6/11/2013

WASHINGTON, June 11, 2013 /PRNewswire-USNewswire/ -- The Center for Lawful Access and Abuse Deterrence (CLAAD) joined in signing a Citizen Petition filed today urging the Food and Drug Administration (FDA) to fully implement the Obama administration's policy supporting a market transition to safer opioid medications. The petition asks that the FDA reject applications for new opioid medications without added safety features.

Opioids are a class of synthetically derived chemicals often used to treat pain or addiction. Opioid analgesics were involved in over 16,000 overdose deaths in 2010 alone, according to the Centers for Disease Control.

The petition praises the FDA's recent steps to shift the market to safer medications, such as the April conclusion that the original OxyContin pill was removed from the market for safety reasons. Copies of the non-abuse-deterrent formulation will not be approved because of this decision.

Recent FDA decisions regarding generic opioids cloud the future of abuse-deterrent medications. In May, the FDA ruled that manufacturers will be allowed to bring to market as early as July 1 more generic forms of a non-abuse deterrent version of Opana ER. The FDA is also expected to decide soon whether to approve an application for a new, pure hydrocodone pill with no abuse-deterrent features.

CLAAD's executive director, Michael Barnes, explained the need for action: "The availability of more generic, non-abuse-deterrent opioids increases the supply of drugs that people are eager and able to abuse. The better approach is to replace that supply with abuse-deterrent medications."

The citizen petition is asking that the FDA act speedily in accordance with the urgency of the national prescription abuse epidemic. By law, the FDA has 180 days to reply.

About the Center for Lawful Access and Abuse Deterrence
The not-for-profit Center for Lawful Access and Abuse Deterrence (CLAAD) coordinates a comprehensive national effort to prevent the prescription drug fraud, diversion, misuse, and abuse while advancing patient access to high-quality medical care. CLAAD enables health professionals, law enforcement, businesses, and government, and others, to share resources and work together to improve public health and safety.  Follow @claad_coalition.


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