A Resolution to Encourage the Clinical Utilization of Opioid Analgesic Drug Products with Formulations that Include FDA-Approved Deterrent Characteristics
REPRESENTATIVE LOUIS RUIZ (KS)
Whereas, the National Hispanic Caucus of State Legislators is the foremost organization serving and representing the interests of Hispanic state legislators from all states, commonwealths and territories of the United States and the Western Hemisphere and serves as a catalyst for joint action on issues of common concern to all segments of the Hispanic community; and
Whereas, the Food and Drug Administration (FDA) released a draft Guidance for Industry on Assessment of Abuse Potential of Drugs in January 2010; and
Whereas, the FDA also released a draft Guidance for Industry on Abuse-Deterrent Opioids –Evaluation and Labeling in January 2013; and
Whereas, there are only 20 opioid analgesic drugs intended to embody abuse-deterrent characteristics in development by at least a dozen innovator or generic pharmaceutical manufacturers; and
Whereas, on a prescription-share basis, the vast majority of opioid analgesics prescribed are generic drug products; and
Now, Therefore Be It Resolved, that NHCSL encourages the FDA to finalize both draft guidance to provide clear direction to pharmaceutical manufacturers developing opioid analgesics in formulations designed to deter abuse; and
Be It Further Resolved, that NHCSL encourages the FDA to release a draft Guidance for Industry on developing of generic opioid drug products with abuse-deterrent characteristics and that such Guidance make clear that generic products must demonstrate abuse-deterrent characteristics that are at least equivalent to the innovator opioid drug product they reference; and
Be It Further Resolved, that NHCSL encourages innovator and generic drug manufacturers to develop opioid analgesics in a manner that comports with Guidance from FDA; and
Be It Further Resolved, that NHCSL encourages public and private payors to avoid disadvantaging opioid drug products with FDA-approved abuse deterrent characteristics by use of differential copayments, formulary tier placement, prior authorization, or other means so as to preferentially increase clinical utilization of opioids with approved abuse deterrent characteristics in an effort to reduce diversion and abuse of opioid analgesics and eventually ensure that only opioid analgesics with abuse-deterrent characteristics are in clinical use.
THIS RESOLUTION WAS ADOPTED ON APRIL 25, 2015, AT THE NHCSL EXECUTIVE COMMITTEE & BUSINESS BOARD OF ADVISORS MEETING HELD IN WASHINGTON, D.C. AND RATIFIED ON NOVEMBER 21, 2015 AT THE NHCSL ANNUAL EXECUTIVE COMMITTEE & BUSINESS BOARD OF ADVISORS MEETING HELD IN ATLANTA, GA.