Gottlieb Tells Brand Firms To Sell Samples For Generics – Or Face The Consequences
The idea could help quiet growing criticism over system gaming and high drug prices.
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The record number of full ANDA approvals also exceeded submissions for the first time since GDUFA was enacted.
Former US FDA commissioner Scott Gottlieb doesn't "want to give too much away," but expresses skepticism about Trump administration's ability to implement its international price index proposal, noting there are ways for brand companies to game the system.
Now that the Senate Finance Committee has unveiled its bill and House leadership has outlined its approach, less comprehensive drug pricing legislation is losing the limelight. But may of the the bills could still have a meaningful impact on pharma, and might even become law, if only because they would be an easier way for politicians to show they were doing something to address the issue.