Aegerion Juxtapid Settlement Shows REMS Have Teeth: Alternate Route To Enforce Off-Label?
Who says FDA can’t bring off-label cases? They may just morph into REMS violation cases – if, that is, FDA starts using the REMS authority more often.
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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.
Complaints should not be allowed to go forward if government knew of regulatory infraction but continued to pay for drug, Gilead argues, asking US high court to 'finish task' of its Escobar ruling.
Settlement is first involving a copay assistance program operated through Caring Voice Coalition since the HHS Office of Inspector General rescinded a safe harbor for the charity's activities in late November. Is it the first of a wave?