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FDA chief favors abuse-deterrent formulations

March 2, 2016
by Julie Miller, Editor in Chief
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According to Associated Press (AP), the Food and Drug Administration's (FDA) newly confirmed commissioner has promised to support the use of abuse-deterrent formulations among medications approved by FDA. Robert Califf told agency leaders that he wants to work closely with prescribers, associations, advocates and state and local partners to prevent and treat substance use disorders.

FDA has come under fire in recent years for several of its new drug approvals, such as Zohydro ER, which the agency approved even though its own advisory committee voted 12-to-2 against it.

Last month, Califf also vowed to retool the agency’s previous approach to opioid medications, while balancing the need for pain control against the risk of addiction. A new expert advisory committee will now be involved in approving any new drug application for an opioid that does not have abuse-deterrent properties, and additional efforts will be focused on label updates.

FDA has approved five abuse-deterrent drugs since 2010, and 30 similar drugs are in development, according to AP.

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