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US FDA ‘Public Health’ Approach To Opioids May Open Up Pricing Debates

 
• By Michael McCaughan

Latest effort by FDA to re-set reviews for novel opioid analgesics is off to a rocky start after three advisory committee reviews. One unintended consequences may already be apparent: by taking a broad, public health perspective on new formulations, the agency may be inviting arguments based on price.

Large US American flag on sailboat off the coast of California

The US Food & Drug Administration’s new “public health” framework for considering opioid analgesic applications made its debut in a series of advisory committee meetings in mid-January – and it did not go well for the sponsors.

Two of the three opioid formulations reviewed – Nektar Therapeutics’s new molecular entity oxycodegol and Intellipharmaceutics International Inc.’...

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