The OxyContin Story: A Timeline Of Accomplishment And Controversy
With a US FDA advisory committee poised to consider Purdue's postmarket data on OxyContin's abuse deterrent formulation, a Pink Sheet infographic looks back on how the product got here.
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From the rise of DTC to the shadow of Caronia, Abrams, the long-time head of the Office of Prescription Drug Promotion, monitored dramatic changes in the pharmaceutical marketplace and regulatory environment. He retired from FDA on 23 October after a tenure marked as much by careful research projects and copious guidances as it was by promotional and legal upheavals.
But advisory committee members caution against including pediatric population in COVID-19 vaccine trials, and one member expresses concern that Pfizer is testing those as young as 12 years of age. Agency is in discussions with product sponsors about enrollment of adolescents.
Purdue pleads guilty to three felony charges over marketing of OxyContin under settlement that requires Purdue to be dissolved and transformed into an entity that provides addiction and overdose medicines. Twenty-five state AGs oppose creation of a PBC, arguing Purdue should be sold to another company.