WASHINGTON, June 11, 2013 /PRNewswire-USNewswire/ -- The Center for Lawful Access and Abuse Deterrence (CLAAD) joined in signing a Citizen's Petition filed today urging the Food and Drug Administration (FDA) to cast aside its all-or-nothing approach to the treatment of opioid dependence. The petition asks that the FDA acknowledge patient outcomes other than abstinence as critical to addiction treatment.
In May, the FDA withheld approval for a buprenorphine implant, contrary to the assessment of its own advisory committee, which found the implant "safe and effective for opioid treatment." For more than 10 years, buprenorphine has been established as a safe and effective addiction treatment.
In its decision, the FDA cited a lack of abstinence as a reason for withholding approval. The FDA stated, "Even after allowing four months for engagement in treatment, only three [buprenorphine implant]-treated patients were fully abstinent from opioids."
Yet the Substance Abuse and Mental Health Services Administration (SAMHSA) reports that Medication-Assisted Treatments like those using buprenorphine "increase survival, increase retention in treatment, decrease illicit opiate use, decrease hepatitis and HIV seroconversion, decrease criminal activities, increase employment, [and] improve birth outcomes with perinatal addicts." Among a litany of benefits, abstinence is not even included the scope of SAMHSA's assessment.
CLAAD Executive Director Michael Barnes said, "The FDA must end its wrongheaded abstinence-only stance, and it must do so with a sense of urgency that reflects that we are in the midst of an opioid abuse epidemic."
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.
Web Site: http://www.claad.org