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-costcompetition to market.

The FDA wants to prioritize certain generic-drug applications inan effort to drive down prices, which have drawn increasingscrutiny from lawmakers and the ire of President Donald Trump. The agency hasits sights set on an incentive granted to drugmakers that are first to seek approval fora copy of a brand-name drug, according to a policy documentreleased Thursday.

Generic-drug makers must submit their medicines to the FDA forapproval. So-called first filers are typically able to sell theirversion of a brand-name drug free from competition from othergenerics for 180 days. When that period is up, the floodgates open-- though a backlog of applications awaiting FDA clearance hasmeant some first filers have had the market to themselves for farlonger.

Complete your profile to continue reading and get FREE access to BenefitsPRO, part of your ALM digital membership.

  • Critical BenefitsPRO information including cutting edge post-reform success strategies, access to educational webcasts and videos, resources from industry leaders, and informative Newsletters.
  • Exclusive discounts on ALM, BenefitsPRO magazine and BenefitsPRO.com events
  • Access to other award-winning ALM websites including ThinkAdvisor.com and Law.com
NOT FOR REPRINT

© 2024 ALM Global, LLC, All Rights Reserved. Request academic re-use from www.copyright.com. All other uses, submit a request to [email protected]. For more information visit Asset & Logo Licensing.