MORGANTOWN — West Virginia’s Republican attorney general has teamed with his Democratic New Mexico counterpart to lead a coalition of 48 attorneys general in a letter asking the U.S. Food and Drug Administration for a progress report on its response to federal legislation to combat opioid abuse.
West Virginia’s Patrick Morrisey and New Mexico’s Hector Balderas sent the letter to FDA Commissioner Stephen Hahn how the FDA is using and plans to use powers granted under the SUPPORT Act (Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities).
The provisions include safer opioid packaging and disposal features, research and issuance of new regulations on non-addictive alternatives to opioids and guidelines for opioid prescribing, they said in a release announcing the letter.
The letter says, “We have witnessed first-hand the devastation that the opioid epidemic has wrought on states in terms of lives lost and the costs it has imposed on our healthcare system and the broader economy. As the chief legal officers of our states, we are committed to using all tools at our disposal to combat this epidemic and to protect patients suffering from chronic pain or addiction, who are among the most vulnerable consumers in our society.”
Among the letter’s points of inquiry:
— What has the FDA done regarding the directive to convene a public meeting covering the challenges in developing non-addictive medicine to treat acute or chronic pain and to issue at least one final guidance document to help address the challenges posed by developing non-addictive pain medications?
— What has the FDA done to develop evidence-based opioid analgesic prescribing guidelines for the indication-specific treatment of acute pain and issue a corresponding report?
— What has it done to require that a drug be made available for dispensing in unit dose packaging, like blister packs, to mitigate serious risk of an adverse drug experience, or to require a drug be dispensed with a safe disposal packaging or safe disposal system for purposes of rendering drugs nonretrievable?
— And finally, what has it done issue to guidance regarding circumstances in which it may require postmarket studies or clinical trials to assess the potential reduction in effectiveness of a drug and how such reduction in effectiveness could result in a change to the benefits of the drug and the risks to the patient?
The release notes that in 2017, Attorney Morrisey co-led a similar effort with many of these same states asking health insurance companies to review and revise their payment and coverage policies to prioritize non-opioid pain management options for treatment of chronic, non-cancer pain.
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