Orphan Drug Act

Summary

Orphan Drug Act - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services to promulgate regulations to exempt from such Act drugs intended solely for drug treatment investigations. Defines "drug treatment investigation" as an investigation of a drug which involves human participants with a rare disease or condition. Establishes in the Department of Health and Human Services an interagency committee known as the Committee on Orphan Drug Development. Makes it the function of such committee to promote the development of drugs for rare diseases or conditions (orphan drugs). Requires the Director of the National Institutes of Health (NIH) to submit to the Committee an annual report on the rare disease and condition research activities of NIH. Requires the Secretary of the Treasury to submit to the Committee an annual report on the use of the tax credit for experimental expenses. Requires the Committee to report by June 1 of each year to the appropriate congressional committees on its activities and the results of its evaluations, including the report submitted by NIH and the Secretary of the Treasury. Amends the Internal Revenue Code to allow a tax credit for qualified experimental expenses incurred while researching orphan drugs.

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1 official file

• Introduced in Senate

  summary · EN · 23 February 1982

  Open at official source

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