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. Labuhn; Jeffrey W. Reynolds; Erin E. Schuler; Ryan W. Naseman; Gary L. Johnson; Robert A. Lodder

doi:10.1007/s12247-022-09659-5

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 journal › Review article › peer-review

8 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 language	English
Pages (from-to)	269-282
Number of pages	14
Journal	Journal of Pharmaceutical Innovation
Volume	17
Issue number	2
DOIs	https://doi.org/10.1007/s12247-022-09659-5
State	Published - 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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10.1007/s12247-022-09659-5

Cite this

Almeter, P. J., Isaacs, J. T., Hunter, A. N., Henderson, B. S., Platt, T., Mitchell, B. J., Do, D., Brainard, A. B., Brown, J. E., Stone, R. M., Nguyen, B. H., Warren, M. F., Bhaktawara, S. A., Bossle, M. N., Long, L. M., Zapata, S. P., Larkin, C. R., Lyman, T. A., Larkin, S. A., ... Lodder, R. A. (2022). FDA Approaches in Monitoring Drug Quality, Forces Impacting the Drug Quality, and Recent Alternative Strategies to Assess Quality in the US Drug Supply. Journal of Pharmaceutical Innovation, 17(2), 269-282. https://doi.org/10.1007/s12247-022-09659-5

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

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.",

keywords = "Drug quality, FDA, Globalization",

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

note = "Publisher Copyright: {\textcopyright} 2022, The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.",

year = "2022",

month = jun,

doi = "10.1007/s12247-022-09659-5",

language = "English",

volume = "17",

pages = "269--282",

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Almeter, PJ, Isaacs, JT, Hunter, AN, Henderson, BS, Platt, T, Mitchell, BJ, Do, D, Brainard, AB, Brown, JE, Stone, RM, Nguyen, BH, Warren, MF, Bhaktawara, SA, Bossle, MN, Long, LM, Zapata, SP, Larkin, CR, Lyman, TA, Larkin, SA, Labuhn, JA, Reynolds, JW, Schuler, EE, Naseman, RW, Johnson, GL & Lodder, RA 2022, 'FDA Approaches in Monitoring Drug Quality, Forces Impacting the Drug Quality, and Recent Alternative Strategies to Assess Quality in the US Drug Supply', Journal of Pharmaceutical Innovation, vol. 17, no. 2, pp. 269-282. https://doi.org/10.1007/s12247-022-09659-5

FDA Approaches in Monitoring Drug Quality, Forces Impacting the Drug Quality, and Recent Alternative Strategies to Assess Quality in the US Drug Supply. / Almeter, Philip J.; Isaacs, James T.; Hunter, Aaron N. et al.
In: Journal of Pharmaceutical Innovation, Vol. 17, No. 2, 06.2022, p. 269-282.

Research output: Contribution to journal › Review article › peer-review

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AU - Almeter, Philip J.

AU - Isaacs, James T.

AU - Hunter, Aaron N.

AU - Henderson, Bradley S.

AU - Platt, Thomas

AU - Mitchell, Billie J.

AU - Do, David

AU - Brainard, Alyssa B.

AU - Brown, Joshua E.

AU - Stone, Rachael M.

AU - Nguyen, Bao Han

AU - Warren, Matthew F.

AU - Bhaktawara, Smaran A.

AU - Bossle, Megan N.

AU - Long, Lindsey M.

AU - Zapata, Stephanie P.

AU - Larkin, Cinnamon R.

AU - Lyman, Thomas A.

AU - Larkin, Seth A.

AU - Labuhn, Jonathan A.

AU - Reynolds, Jeffrey W.

AU - Schuler, Erin E.

AU - Naseman, Ryan W.

AU - Johnson, Gary L.

AU - Lodder, Robert A.

PY - 2022/6

Y1 - 2022/6

N2 - 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.

AB - 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.

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DO - 10.1007/s12247-022-09659-5

M3 - Review article

AN - SCOPUS:85131307510

SN - 1872-5120

VL - 17

SP - 269

EP - 282

JO - Journal of Pharmaceutical Innovation

JF - Journal of Pharmaceutical Innovation

IS - 2

ER -

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

Abstract

Bibliographical note

Keywords

ASJC Scopus subject areas

Access to Document

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