Compounding Bill In Senate Gets Bipartisan Push For Floor Vote
This article was originally published in The Pink Sheet Daily
HELP Committee leaders Harkin and Alexander write letter arguing that FDA’s warnings of more problems from tainted compounded medications have come true and that their legislation should gain a vote next month.
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The stripped down version will generate considerably less user fee revenue for FDA, but so far it has met the same fate in the Senate as other recent legislation coming from the House.
No mention of affects to Medicare, Medicaid in the CBO score for the Senate compounding and supply chain bill, but FDA is likely to need more budget authority given that expected user fee revenues are not expected to cover the full costs of the new programs.
FDA and stakeholders reiterate that volume cannot be the sole measure of whether a compounder should be regulated like a drug manufacturer; Rep. Griffith pitches potentially using it and other indicators to draw the line.