NEJM Takes Aim At Expensive Accelerated Approval Drugs Amid Congressional Drug Pricing Debate
Authors propose imposing penalties on drugmakers who don't start confirmatory trials shortly after accelerated approval and additional discounts for public payers; proposals could pick up steam among congressional democrats amid their renewed call for lower drug prices.
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Oncologic Drugs Advisory Committee will meet for three days in April to consider whether indications for Tecentriq, Keytruda and Opdivo should remain on label despite failure to confirm clinical benefit; review is part of the Oncology Center of Excellence’s ‘industry-wide evaluation’ of accelerated approvals, which has led to withdrawals of four other PD-1/L-1 inhibitor claims.
Pink Sheet interactive timeline looks at key regulatory, policy and legislative developments impacting the accelerated approval pathway over the last 10 years.
US FDA's to-do list also includes guidances on development of non-opioid analgesics and cannabis compounds, evaluation of generic therapeutic equivalence, and pediatric product development.