FDA Approaches in Monitoring Drug Quality, Forces Impacting the Drug Quality, and Recent Alternative Strategies to Assess Quality in the US Drug Supply

Philip J. Almeter, James T. Isaacs, Aaron N. Hunter, Bradley S. Henderson, Thomas Platt, Billie J. Mitchell, David Do, Alyssa B. Brainard, Joshua E. Brown, Rachael M. Stone, Bao Han Nguyen, Matthew F. Warren, Smaran A. Bhaktawara, Megan N. Bossle, Lindsey M. Long, Stephanie P. Zapata, Cinnamon R. Larkin, Thomas A. Lyman, Seth A. Larkin, Jonathan A. LabuhnJeffrey W. Reynolds, Erin E. Schuler, Ryan W. Naseman, Gary L. Johnson, Robert A. Lodder

Research output: Contribution to journalReview articlepeer-review

4 Scopus citations

Abstract

Since the US Food and Drug Administration (FDA) began monitoring the quality of pharmaceutical manufacturing by enforcing current good manufacturing practices roughly 60 years ago, forces related to the global economy have changed, rendering the task of monitoring quality more difficult. Alternative strategies by groups like Valisure, LLC, and the University of Kentucky Drug Quality Study to monitor the quality of the currently circulated US drug supply through end-product testing and screening have resulted in several concerning findings. Given the successful approaches of identifying quality defects in pharmaceuticals by non-regulatory bodies, and considering the changing landscape and pressures on manufacturing, the FDA, large buying groups, and the US Department of Defense should consider these alternative strategies as a means to augment current regulatory activities.

Original languageEnglish
Pages (from-to)269-282
Number of pages14
JournalJournal of Pharmaceutical Innovation
Volume17
Issue number2
DOIs
StatePublished - Jun 2022

Bibliographical note

Publisher Copyright:
© 2022, The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.

Keywords

  • Drug quality
  • FDA
  • Globalization

ASJC Scopus subject areas

  • Pharmaceutical Science
  • Drug Discovery

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