This course covers 7 key areas important to setting a foundation in the understanding of orphan drugs.
✓ The definition of an orphan drug and rare disease or condition, and the prevalence of rare diseases or conditions in the U.S.
✓ The key elements of the Orphan Drug Act of 1983 including why it was implemented, qualifications for inclusion, and incentives for participation
✓ The FDA expedited drug approval mechanisms commonly used by manufacturers for orphan drugs and the Priority Review Voucher Program
✓ Scientific factors influencing the rise in diagnosis and treatment of rare diseases
✓ The rise in orphan drug costs and how it compares to non-orphan drug costs
✓ The main components used by plan sponsors to manage orphan drugs
✓ Significant challenges sometimes faced by patients with a rare disease or condition