TY - JOUR
T1 - Association between US Pharmacopeia (USP) monograph standards, generic entry and prescription drug costs
AU - Murimi-Worstell, Irene B.
AU - Ballreich, Jeromie M.
AU - Seamans, Marissa J.
AU - Caleb Alexander, G.
N1 - Funding Information:
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.
Publisher Copyright:
© 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.
PY - 2019/11/1
Y1 - 2019/11/1
N2 - 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.
AB - 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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U2 - 10.1371/journal.pone.0225109
DO - 10.1371/journal.pone.0225109
M3 - Article
C2 - 31714946
AN - SCOPUS:85074889630
SN - 1932-6203
VL - 14
JO - PLoS One
JF - PLoS One
IS - 11
M1 - e0225109
ER -