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In Response to Abuse Epidemic, Congress Should Give Drug Makers a Deadline To Make Their Products Safer

March 3, 2015 – Washington, D.C. – Congress should give the manufacturers of controlled-substance medications a deadline to replace their products with abuse-deterrent formulations (ADFs), according to an article published today in Therapeutic Advances in Drug Safety. ADFs are reformulations of medications designed to resist ingestion via altered routes of administration, such as snorting, injecting, or smoking.

The Centers for Disease Control and Prevention reports that 120 people in America die every day from overdoses, and more than half of these deaths involve pharmaceuticals. Every year over 1.4 million emergency department visits are related to prescription medications.

Kyle A. Simon, M.S., of the not-for-profit Center for Lawful Access and Abuse Deterrence (CLAAD), and coauthors concluded that abuse-deterrent drug technologies are still in their early stages and do not prevent all forms of medication abuse, but that “any reduction in prescription drug abuse and the related risks of overdoses, diseases contracted by intravenous drug use, or deaths is a positive societal outcome.”

The authors recommend that Congress require the makers of the most powerful (Schedule II) controlled-substance medications to convert their products to ADFs by a specific date. Current federal policy “does not reflect the urgency of the prescription drug abuse epidemic and does not go far enough toward changing the status quo,” the article states.

The authors also call for the Food and Drug Administration to provide pharmaceutical manufacturers clearer guidance on how to collect and report data as part of the ADF approval and labeling process.

The article is now accessible at http://taw.sagepub.com and will be published in the April 2015 edition of Therapeutic Advances in Drug Safety.

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About CLAAD

CLAAD coordinates a comprehensive national effort to prevent prescription drug fraud, diversion, and abuse while advancing consumer access to high-quality medical care. CLAAD enables health professionals, law enforcement, businesses, government, and others, to share resources and work together to improve public health and safety. Follow @CLAAD_Coalition.

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