Now that the Food and Drug Administration plans to fast-track generic drug applications in hopes of spurring competition and lowering medicines costs, a key question should be asked: Can the agency follow through? A new government report suggests that — yes, the FDA does have the wherewithal.

Thanks to a program in which industry pays fees so the FDA can more readily review drugs and inspect plants, the agency has already been reviewing generic drug applications at a faster clip. In fiscal year 2012, the agency spent 28 months on reviews, but that fell to 14 months by fiscal year 2015, according to a newly released report by the U.S. Government Accountability Office.

Unlock this article by subscribing to STAT Plus and enjoy your first 30 days free!


What is it?

STAT Plus is a premium subscription that delivers daily market-moving biopharma coverage and in-depth science reporting from a team with decades of industry experience.

What's included?

  • Authoritative biopharma coverage and analysis, interviews with industry pioneers, policy analysis, and first looks at cutting edge laboratories and early stage research
  • Subscriber-only networking events and panel discussions across the country
  • Monthly subscriber-only live chats with our reporters and experts in the field
  • Discounted tickets to industry events and early-bird access to industry reports

Leave a Comment

Please enter your name.
Please enter a comment.

Sign up for our Daily Recap newsletter

A roundup of STAT’s top stories of the day in science and medicine

Privacy Policy