Commentary on the Benefits of US Pharmacopeial Standards: A Generic Pharmaceutical Industry Survey

Abstract

Pharmacopeial quality standards for medicines are associated with ensuring quality, but they can also facilitate innovation and competition in pharmaceutical markets. Unpublished data suggest that pharmacopeial quality standards, while not associated with increasing the likelihood of a first generic entrant in the market, are associated with increasing the overall number of generic entrants. This commentary describes an online survey of finished-dose generic drug manufacturers in the United States and India that explores whether using pharmacopeial documentary standards and physical reference standards (RSs) such as those developed by the US Pharmacopeial Convention, accelerate generic drug development and reduce the duration, cost, and risk involved in bringing generic drugs to the US market. The survey provides new evidence that using pharmacopeial documentary standards and physical RSs (1) saves generic drug companies 19% of the time spent on generic product development overall and 31% of time spent on analytical method development and (2) provides clear guidance on quality, thereby reducing the perceived risk of Abbreviated New Drug Application rejection by the US Food and Drug Administration. Ninety percent of respondents agreed that the use of pharmacopeial documentary standards accelerated product development compared with 85% for physical RSs; and 92% of respondents agreed that the use of documentary standards and physical RSs reduced the risk that their Abbreviated New Drug Application would be rejected. Owing to the relatively small sample size of the survey, the results should be viewed as entirely directional for use in trends analysis on the finished-dose generic pharmaceutical industry. The margin of error for all results is 8%-14% at a 95% confidence interval.