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December 12, 2017

High Costs of FDA Approval for Formerly Unapproved Marketed Drugs

Author Affiliations
  • 1Yale University School of Medicine, New Haven, Connecticut
  • 2Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland
  • 3Section of General Internal Medicine, Department of Medicine, Yale University School of Medicine, New Haven, Connecticut
  • 4Center for Outcomes Research and Evaluation, Yale–New Haven Hospital, New Haven, Connecticut
JAMA. 2017;318(22):2181-2182. doi:10.1001/jama.2017.16481

In May 2017, the US Food and Drug Administration (FDA) announced a Drug Competition Action Plan, designed to address competition and pricing in the generic market and improve access to prescription drugs.1 One of FDA’s stated goals is to reexamine “places where its rules—including standards and procedures related to generic drug approvals—are being used in ways that may create obstacles to generic access,”1 instead of ensuring the vigorous competition Congress intended. In this Viewpoint, we examine FDA’s 2006 Unapproved Drugs Initiative (UDI), designed to strengthen the agency’s regulatory oversight related to unapproved marketed drugs. Using an illustrative example, we discuss this initiative’s unintended consequences, as it appears to have created obstacles to generic drug access, likely increasing prescription drug costs.