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The Food and Drug Administration’s Role in Promoting Consistent Labels for Generic Drugs

Jon D. Duke, MD, MS1,2; Aaron S. Kesselheim, MD, JD3
[+] Author Affiliations
1Regenstrief Institute, Indianapolis, Indiana
2Department of Medicine, Indiana University School of Medicine, Indianapolis
3Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts
JAMA Intern Med. 2014;174(8):1213-1214. doi:10.1001/jamainternmed.2014.2705.
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The product information for a prescription drug—commonly called its label—is the full description of the drug’s indications for use, method of administration, warnings, contraindications, and potential adverse events. It is written by the manufacturer of the brand-name drug, approved by the US Food and Drug Administration (FDA), and published when the drug initially is marketed. As new effectiveness or safety information becomes available during the period of marketing exclusivity, the manufacturer must update the label and maintain it as an accurate reference. Once a brand-name drug loses its market exclusivity, the manufacturers of generic versions must disseminate a label that mimics the safety information for the brand-name drug. The labels of generic drugs are important to public health; over 84% of all prescriptions that are filled in the United States are for generic drugs.1 Frequently, serious new safety issues are identified after generic versions of a drug become available.2

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