HealthLeaders Media May 8, 2024
It’s the second-largest criminal financial penalty levied against a drug maker.
KEY TAKEAWAYS
– EHSI pled guilty on April 18 to one count of introducing misbranded drugs into interstate commerce.
– The drugmaker admitted that its sales reps marketed Opana ER to physicians by baselessly claiming that the opioid was tamper- and crush-resistant and thus purportedly deterred abuse.
– EHSI admitted it was responsible for the misbranding of Opana ER by marketing the drug with a label that failed to include adequate directions for its claimed abuse deterrence use, in violation of the FDCA.
– EHSI stopped selling Opana ER in 2017. The drugmaker was shut down during the bankruptcy process and not allowed to continue its prior form when...
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