As the issue of drug pricing has continued to pick up steam across congressional user fee reauthorization hearings, a new series of drug pricing proposals could catch the attention of lawmakers seeking to explore options beyond the generic drugs route to lowering prices.
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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A risk-based approach to human cell therapies and tissue-based products could incentivize development and prevent bad actors from taking advantage of the current FDA system.