In 1988, the Orphan Drug Act was barely five years old and still coming of age in the industry, but even then, manufacturers were starting to see the potential competitive advantage of orphan drug status. Currently, the future of orphan drug development looks likely to be increasingly active, as the pharmaceutical industry advances toward personalized medicine.

As part of its 25th anniversary celebration this year, BioPharm International invited NAI Managing Partner, Michael N. Abrams, M.A., to reflect on 25 years of orphan drug development in the U.S. His article, A 25-Year Retrospective on Orphan Drugs, looks back at the brief history of orphan drugs, and offers forecasts for their likely future.