Orphan Drug Program Improvement Act of 2001

Orphan Drug Program Improvement Act of 2001 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services, respecting application approval or licensing, to conform the designation of a drug for a rare disease or condition (orphan drug) to reflect such drug's approved labeling.

Exempts clinically superior subsequent orphan drugs from the seven-year prohibition of approval respecting a previously approved or licensed drug.