The Benefits from Giving Makers of Conventional 'Small Molecule' Drugs Longer Exclusivity Over Clinical Trial Data

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.