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      Association between US Pharmacopeia (USP) monograph standards, generic entry and prescription drug costs

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          Abstract

          Despite the importance of pharmacopeial standards, little is known regarding their effect on drug competition. Such information is of particular relevance given the rising costs of prescription drugs and the focus of policy-makers and other stakeholders on addressing these costs. We examined 982 prescription drugs approved by U.S Food and Drug Administration since 1982 to examine the association between U.S. Pharmacopeia (USP) standards, generic entry and prescription costs. The presence of a USP drug product monograph was not associated with the time to the third generic entrant or with the likelihood of having a generic competitor. However, on average, drugs with USP drug product monographs had approximately fifty percent more generic manufacturers in the U.S. than their counterparts after accounting for factors such as market volume, age, route of administration and vintage. This greater competition was associated with an approximate savings of $6.22 billion in 2016, suggesting that USP drug product monographs may play an important role in promoting pharmaceutical competition and reducing prescription drug costs.

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          Most cited references11

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          Prices of Generic Drugs Associated with Numbers of Manufacturers

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            Strategies that delay or prevent the timely availability of affordable generic drugs in the United States

            High cancer drug prices are influenced by the availability of generic cancer drugs in a timely manner. Several strategies have been used to delay the availability of affordable generic drugs into the United States and world markets. These include reverse payment or pay-for-delay patent settlements, authorized generics, product hopping, lobbying against cross-border drug importation, buying out the competition, and others. In this forum, we detail these strategies and how they can be prevented.
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              Using a drug-safety tool to prevent competition.

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                Author and article information

                Contributors
                Role: ConceptualizationRole: Data curationRole: Formal analysisRole: MethodologyRole: Writing – original draft
                Role: ConceptualizationRole: Formal analysisRole: MethodologyRole: Writing – review & editing
                Role: ConceptualizationRole: MethodologyRole: Writing – review & editing
                Role: ConceptualizationRole: Funding acquisitionRole: MethodologyRole: SupervisionRole: Writing – review & editing
                Role: Editor
                Journal
                PLoS One
                PLoS ONE
                plos
                plosone
                PLoS ONE
                Public Library of Science (San Francisco, CA USA )
                1932-6203
                12 November 2019
                2019
                : 14
                : 11
                : e0225109
                Affiliations
                [1 ] Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America
                [2 ] Center for Drug Safety and Effectiveness, Johns Hopkins University, Baltimore, Maryland, United States of America
                [3 ] Department of Health Policy & Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America
                [4 ] Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America
                [5 ] Division of General Internal Medicine, Department of Medicine, Johns Hopkins Medicine, Baltimore, Maryland, United States of America
                University of California Berkeley, UNITED STATES
                Author notes

                Competing Interests: Caleb Alexander serves as Chair of FDA’s Peripheral and Central Nervous System Advisory Committee; serves as a paid advisor to IQVIA; holds equity in Monument Analytics, a health care consultancy whose clients include the life sciences industry as well as plaintiffs in opioid litigation; and is a member of OptumRx’s National P&T Committee. This arrangement has been reviewed and approved by Johns Hopkins University in accordance with its conflict of interest policies. The other authors have no relevant associations to disclose. These disclosures and the data purchase agreements outlined in the submission portal does not alter our adherence to PLOS ONE policies on sharing data and materials.

                [¤]

                Current address: Program in Pharmaceutical Economics and Policy, Massachusetts College of Pharmacy and Health Sciences, Boston, Massachusetts, United States of America

                Author information
                http://orcid.org/0000-0002-8442-4286
                Article
                PONE-D-19-06585
                10.1371/journal.pone.0225109
                6850553
                31714946
                4f49b8e5-4f17-480a-aba9-1df713bfce20
                © 2019 Murimi-Worstell et al

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                : 6 March 2019
                : 29 October 2019
                Page count
                Figures: 2, Tables: 4, Pages: 11
                Funding
                Funded by: funder-id http://dx.doi.org/10.13039/100006026, United States Pharmacopeia;
                Award Recipient :
                This work was funded by a grant from U.S. Pharmacopeia, who participated in the design and conduct of the study, analysis and interpretation of the data, and review of the final manuscript, although the decision to submit the manuscript for publication was the authors’ alone.
                Categories
                Research Article
                Medicine and Health Sciences
                Pharmacology
                Routes of Administration
                Medicine and Health Sciences
                Pharmacology
                Drug Information
                Medicine and Health Sciences
                Pharmacology
                Drug Research and Development
                Medicine and Health Sciences
                Pharmaceutics
                Drug Therapy
                Drug Administration
                Biology and Life Sciences
                Psychology
                Addiction
                Addicts
                Drug Users
                Social Sciences
                Psychology
                Addiction
                Addicts
                Drug Users
                Medicine and Health Sciences
                Pharmacology
                Drug Research and Development
                Drug Discovery
                Medicine and Health Sciences
                Pharmacology
                Drug Research and Development
                Drug Marketing
                Medicine and Health Sciences
                Pharmacology
                Drug Screening
                Custom metadata
                The IQVIA World Review Track Data used in this study is third party data and is available for purchase by all researchers from the data vendor IQVIA. It can be purchased through the following link: https://www.iqvia.com/. Those interested would be able to access the data in the same manner as the authors. The authors did not have any special access privileges that other would not have. The USP Monograph Directory is available for purchase through www.usp.org. The other data sources namely the FDA Orange Book and National Drug Codes (NDC) Directory are available on the U.S food and Drug administration website ( www.fda.gov).

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