Makers of copycat drugs will face pressure to bring down prices even more quickly as the U.S. Food and Drug Administration pushes to get more low-cost competition to market.
The FDA wants to prioritize certain generic-drug applications in an effort to drive down prices, which have drawn increasing scrutiny from lawmakers and the ire of President Donald Trump. The agency has its sights set on an incentive granted to drugmakers that are first to seek approval for a copy of a brand-name drug, according to a policy document released Thursday.
Generic-drug makers must submit their medicines to the FDA for approval. So-called first filers are typically able to sell their version of a brand-name drug free from competition from other generics for 180 days. When that period is up, the floodgates open -- though a backlog of applications awaiting FDA clearance has meant some first filers have had the market to themselves for far longer.
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