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.
Highlights
Administered drugs had the highest prevalence of both drug product and drug substance monographs among all products. (Table 1) Half (51%) of the drug product monograph standards were established before the first generic entered the market
After adjusting for potential confounders, there was no statistically significant difference in the likelihood of having a generic manufacturer based on the presence of a U.S. Pharmacopeia (USP) drug product monograph
Our findings suggest USP drug product monographs may be an important facilitator of generic competition
Summary
Rising prescription drug costs in the United States represent a significant challenge to patients, providers and the health care system alike. [1] For example, among patients currently taking a prescription medication, 19% report that they or a family member have cut pills in half or skipped doses while 24% report that they or a family member have failed to fill a prescription because of cost.[2]. Using the output from the main statistical model which examined the effect of drug product monographs on the number of generic entrants, we estimated the cost savings associated with USP drug product monographs by comparing actual sales for a drug with a drug product monograph for a given year with the predicted sales for the same drug if no drug product monographs were established. Since not all first generic manufacturers have 180-days of market exclusivity and given the notable price reduction associated with the entry of the second generic manufacturer into the market, we performed a secondary analysis examining the association having a drug product USP monograph the time between the first and second generic entrant. The study was exempted from a Johns Hopkins Bloomberg School of Public Health Institutional Review Board review
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