The Benefits From Giving Makers Of Conventional ‘Small Molecule’ Drugs Longer Exclusivity Over Clinical Trial Data
- Dana P. Goldman ( [email protected] ) is the Norman Topping Chair in Medicine and Public Policy and director of the Leonard D. Schaeffer Center for Health Policy and Economics, both at the University of Southern California, in Los Angeles. He is also a senior economist at the RAND Corporation in Santa Monica.
- Darius N. Lakdawalla is a tenured associate professor at the University of Southern California’s School of Policy, Planning, and Development and director of research at the Leonard D. Schaeffer Center for Health Policy and Economics.
- Jesse D. Malkin is a consultant at Precision Health Economics, in Santa Monica, California.
- John Romley is a research assistant professor at the School of Policy, Planning, and Development, University of Southern California.
- Tomas Philipson is the Daniel Levin Professor of Public Policy Studies at the Irving B. Harris Graduate School of Public Policy Studies, University of Chicago, in Illinois.
Abstract
Pharmaceutical companies and generic drug manufacturers have long been at odds over “data exclusivity” regulations. These rules require a waiting period of at least five years before generic drug companies can access valuable clinical trial data necessary to bring less expensive forms of innovative drugs to market. Pharmaceutical companies want the data exclusivity period lengthened to protect their investment. Generic manufacturers want the period shortened so that they can bring less expensive versions of drugs to patients sooner. We examine the long-term effect of extending the data exclusivity period for conventional “small-molecule” drugs to twelve years—the same exclusivity period already extended to large-molecule biologic drugs under the Affordable Care Act. We conclude that Americans would benefit from a longer period of data exclusivity.
