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

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 pre...

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Published inPloS one Vol. 14; no. 11; p. e0225109
Main Authors Murimi-Worstell, Irene B, Ballreich, Jeromie M, Seamans, Marissa J, Alexander, G Caleb
Format Journal Article
LanguageEnglish
Published United States Public Library of Science 12.11.2019
Public Library of Science (PLoS)
Subjects
Backup software
Biology and Life Sciences
Competition
Costs
Drug approval
Drug Costs
Drugs
Drugs, Generic - economics
Economic aspects
Evaluation
Generic drugs
Humans
Medicine and Health Sciences
Pharmaceuticals
Pharmacology
Pharmacopoeias as Topic
Prescription Drugs - economics
Prescriptions (Drugs)
Product development
Social Sciences
United States > US
Maryland
Massachusetts
Baltimore Maryland
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Summary: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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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
ISSN:1932-6203
1932-6203
DOI:10.1371/journal.pone.0225109