Generic Savings: REMS Obstruction, Not ANDA Backlog, Is Main Hindrance, AAM Says
Association for Accessible Medicines report highlights continuing upward trend of cost savings from generic drugs; trade group argues legislative proposals addressing restricted distribution misuse are key to accelerating savings.
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FDA User Fee Bill: House Cmte. Makes Technical Changes, Adds Pricing Resolution
House Energy and Commerce Committee refines FDA Reauthorization Act and adopts a ‘sense of Congress’ resolution on drug pricing, but largely steers clear of other potentially controversial add-ons that could bog down the measure.
Generic Drug Roadblock: 74 Brands Subject To REMS, Other Restrictions
Report sponsored by Association for Accessible Medicines in US says drugs with restricted distribution programs had total sales of $22.7bn in 2016; seven drugs had sales topping $1bn.
Brand Exclusivity 'Gaming' To Be Addressed At US FDA Meeting
Commissioner Gottlieb outlines several steps agency is taking – including potentially dropping requirement for shared REMS – to create more competitive generic marketplace.