• The Orphan Drugs Act gives pharmaceutical companies incentives to develop treatments for rare diseases, including a 25% tax credit for qualified clinical trials.

  • Other incentives include a rebate on application fees and a seven-year drug exclusivity window.
  • The law was passed in 1983 and resulted in the approval of more than 780 products for the treatment of more than 250 rare diseases.
  • About half of the approved treatments are in the field of oncology (cancer treatment).