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February 2, 2016

Role of the FDA in Affordability of Off-Patent Pharmaceuticals

Author Affiliations
  • 1Department of Medicine and Institute of the History of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland
  • 2Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland
JAMA. 2016;315(5):461-462. doi:10.1001/jama.2015.18720

In recent weeks, the increasing prices of off-patent pharmaceuticals have been the subject of extensive news coverage and debate, a public meeting at the Department of Health and Human Services (HHS), and hearings in both houses of Congress.1 The US Food and Drug Administration (FDA) has not played a central role to date in developing solutions to this challenge. No doubt this reflects the agency’s traditional reluctance to engage with the economic issue of drug pricing. Yet because FDA approves the generic products that establish competitive markets, the agency should have a more active role in ensuring that patients have access to essential drugs that have been affordable for many years.

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