2016 was Record-Setting Year for Generic Drug Approvals, Reports FDA

March 6, 2017

In a recent post on the FDA Voice blog, the Agency reported that its generic drug program hit record highs in 2016.  In the blog post, Kathleen “Cook” Uhl, M.D., Director of FDA’s Office of Generic Drugs (OGD), states that “the timing couldn’t be better amid concerns about rising drug prices.”

The following are important to note about this advancement:

  1. OGD approved more than 800 generic drugs in 2016, a new annual high. This number includes both full and tentative approvals, which Uhl states “are granted to applications ready for approval from a scientific perspective, but cannot be fully approved due to patents or exclusivities on the brand-name drug.”
  2. Last year’s performance surpassed the Agency’s previous record of 726 generic drug approvals, achieved in 2015.
  3. Many of the drug approved were ‘first time generics.’ Uhl states that this is typically the first step in lowering drug prices because it drives price competition.
  4. Uhl credits the Generic Drug User Fee Amendments (GDUFA) of 2012 for the OGD’s record-breaking performance, because it “completely reshaped the generic drug program at FDA.”
  5. OGD is on track to meet all of its GDUFA commitments, and in addition to increased approvals, “FDA improved communications processes to alert industry to deficiencies in their applications, which reduces the number of review cycles and supports faster approvals.”

To read the full story, view FDA’s blog post.  For additional details and data related to OGD’s 2016 performance, view the Agency’s annual report.

Are you in the process of developing a generic drug?  Are you seeking FDA-approval of a generic product?  Using our proprietary approach to FDA, we can help with these or any other FDA-related matters.  To learn more about our services and how we can help you, contact us today.

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