GMP Violations Won’t Trigger Breach Of DOJ Compliance Agreement, Government Attorneys Say
Responding to concerns about ‘over criminalization’ of companies subject to deferred prosecution agreements, FDA and DOJ attorneys note that getting a form 483 won’t breach compliance provisions. Avanos Medical’s 2021 agreement is to be model going forward.
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The settlements resolve False Claims Act allegations against St. Jude and Alere, as well as misbranding allegations against Avanos Medical.
Drug manufacturer reimbursement support services also are garnering a growing amount of enforcement attention, and misleading promotion - whether on- or off-label - remains on the radar of government investigators.
Existing emergency use authorizations to remain in effect and FDA may continue to issue new ones. Pfizer and Merck are moving to transition Paxlovid and Lagevrio to full approval as FDA allows prescribing without a positive COVID test first.