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Comment & Response
January 2017

Prioritization of Generic Drug Review

Author Affiliations
  • 1Center for Drug Evaluation and Research, Office of Generic Drugs, US Food and Drug Administration, Silver Spring, Maryland
JAMA Intern Med. 2017;177(1):140-141. doi:10.1001/jamainternmed.2016.7811

To the Editor In a recent issue of JAMA Internal Medicine, Gupta et al1 provided an excellent summary of the impact of the 1984 Hatch-Waxman Amendments on the availability of quality, affordable generic versions of brand name pharmaceuticals. As Gupta et al indicate, generic drugs now constitute nearly 90% of dispensed medications in the United States. The Office of Generic Drugs of the US Food and Drug Administration (FDA) recognizes the importance of generic drugs to patients, clinicians, and the pharmaceutical industry, and have structured the review processes with the goal of making safe, effective, and affordable generic drugs available as soon as possible. To support that goal, we prioritize generic drug applications for drugs that are “first generics” for which there is no generic approved; “sole-source” drug products for which there is only 1 approved generic product marketed; and drugs that are in shortage, among others.2 Because they are public health priorities, we expedite the review of these generic applications like an express lane at the supermarket.

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