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Comment & Response
January 2017

Prioritization of Generic Drug Review—Reply

Author Affiliations
  • 1Yale University School of Medicine, New Haven, Connecticut
  • 2Harvard Medical School, Boston, Massachusetts
JAMA Intern Med. 2017;177(1):141-142. doi:10.1001/jamainternmed.2016.7817

In Reply We appreciate the response to our work1 from Toufanian and colleagues at the US Food and Drug Administration (FDA) Office of Generic Drugs and applaud the FDA’s commitment to ensuring patient access to affordable, safe, and effective medications through its stewardship of the generic drug market. However, we believe that additional steps could be taken. For instance, while the FDA prioritizes and expedites review of generic drug applications for drug products with 0 or 1 generic version, as well as applications that could resolve a current drug shortage or prevent future shortages,2 any product with 3 or fewer manufacturers is at risk of entering into a shortage.3 To ensure a stable generic drug marketplace, the FDA should also prioritize applications for drug products meeting this criterion. Similarly, dramatic price increases can make essential drugs inaccessible to patients—creating a de facto shortage—suggesting that the FDA should also prioritize applications for generic drugs that have increased in price 2-fold or more in the past 2 years, or adopt some similar threshold.

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