FDA Broadens Generic Drug Competition Efforts, Pressuring Prices - (Bloomberg via NewsPoints Desk)

  • The FDA has unveiled plans to speed the availability of generic drugs after first-to-file rights expire, Bloomberg reported Thursday.

  • FDA Commissioner Scott Gottlieb explained that the initiative seeks to clear the backlog of applications awaiting review and approval.

  • "Soon after the 180-day exclusivity period lapses, consumers can have the benefit of brisk competition from multiple other generic entrants," Gottlieb stated, adding "this can improve affordability and access to important drugs."

  • Gottlieb previously promised to clear the backlog of generic drug applications within a year.

  • Gottlieb also indicated that the agency will prioritise applications seeking approval of therapies with less than three generic options.

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