Hydrocodone Gets Advisory Committee Review, Offering Congress A Scheduling Out
This article was originally published in The Pink Sheet Daily
FDA announces the October meeting unusually early following legislative efforts to further restrict access to the opioid pain reliever due to abuse worries.
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FDA’s recommendation that combination hydrocodone products be moved to the more restrictive Schedule II will increase the regulatory burdens for physicians and pharmacies while making the already restricted extended-release oxycodone products relatively more appealing.
FDA’s Drug Safety and Risk Management Advisory Committee votes 19-10 to move the opioid drugs to the more restrictive Schedule II because their abuse potential is similar to other drugs already that already have the controlled substances designation.
Resolution of issues in conference committee largely favors the brand industry, and swift passage will allow the legislation to avoid becoming a political football after the Supreme Court’s ruling on health care reform.