FDA Pressed To Clarify Permissible Formulary, Clinical Guideline Communications
This article was originally published in The Pink Sheet Daily
Citizen petition from seven firms asks agency to issue regulations related to four areas of off-label communications.
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Agency originally said it would issue a draft guidance on industry’s interactions with formulary committees in 2014, but CDER Director Woodcock says “extremely contentious” issues have slowed progress.
Agency grants two citizen petitions from a coalition of pharma companies requesting greater clarity from FDA, but whether the forthcoming guidances will satisfy industry remains an open question.
PhRMA and the Medical Information Working Group say the lack of clarity around FDAMA Sec. 114’s provisions governing dissemination of health care economic data to formulary committees warrants the medical policy council’s attention.