Did OxyContin Labeling Change Help Fuel Opioid Epidemic? Republicans Want More Data From FDA
Members of House Energy & Commerce Committee reiterate concerns that 2001 label revision may have been used to help promote higher dosage and longer-term prescriptions of OxyContin. J&J boosts opioid litigation settlement offer to $5bn.
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The company will pay $1.6bn to settle opioid litigation and $260m to settle a Medicaid rebate dispute related to Acthar Gel under a restructuring support agreement.
Purdue’s postmarketing studies leave many unanswered questions about reformulated OxyContin, including the ‘million-dollar’ question of its impact on addiction. Advisory committee members ask for clarity on what constitutes ‘meaningful reduction’ in abuse and advise FDA on what to tell the public about the data.
Filing stays litigation but state attorneys general will be battling company's settlement proposal in US bankruptcy court. Details emerge on Purdue finances, rebate expenditures and litigation costs.