A new study finds that extending the term of exclusive access to clinical drug trial data will lead to higher drug costs in the short term but also to more than 200 extra drug approvals and to greater life expectancy in the next several decades. The study, which appears in the journal Health Affairs, is the first to calculate the financial and social costs of limiting access to trial data.
“Elected officials are unlikely to embrace legislation that would result in higher drug prices, but our research suggests that legislation to extend data exclusivity would spur innovation that would benefit future generations,” said Dana Goldman, director of the Schaeffer Center for Health Policy and Economics at the University of Southern California (USC) and Norman Topping Chair of Medicine and Public Policy at USC.
The pharmaceutical companies that introduce new drugs are currently granted 5 years of exclusive access to the clinical trial data they submit during the approval process. An extension of 3 years is available if new applications arise and a 6 month extension is granted if the drug is approved for use in pediatric populations.
In 2007, the National Academies Committee on Science, Engineering and Public Policy called for extending this “data exclusivity” term to the longer period used in Europe, 10 to 11 years. But generic manufacturers have argued for shorter limits so that they can bring less expensive versions of drugs to patients sooner.
In this study, the researchers estimate that extending the term of data exclusivity to 12 years would increase the lifetime revenue of a drug by 5%, on average. With empirical evidence that profits drive drug innovation, this longer term would lead to an additional 228 drug approvals over the next 50 years and an increase of 1.7 months in average life expectancy, according to the study.
“Americans in the early 2020’s would bear the cost of increasing drug spending. However, people turning 55 in 2060 could expect increased life expectancy as a result of innovation in the interceding years—that is, new drugs brought to market because of lengthier data exclusivity,” said John Romley, an economist with the Schaeffer Center and research assistant professor at the USC School of Policy, Planning, and Development.
Source: University of Southern California