Drug Shortage Prevention May Fall To Payers As FDA Rolls Out New Reg
This article was originally published in The Pink Sheet Daily
Even as agency touts its progress and expands its powers, it acknowledges the limits of notification.
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The agency has the option to issue regulations requiring biologics manufacturers to notify FDA of emerging production problems, but so far it’s only “something that we’re thinking about.”
Sterile injectable products with three or fewer manufacturers would get better federal reimbursement rates in an effort to attract more producers to the market; H.R. 6611 was modeled after a similar proposal from Sen. Orrin Hatch, R-Utah.
Interim final rule redefines the terms “sole manufacturer” and “discontinuance.”