Orphan Drug Amendments of 1988

(Measure passed House, amended, roll call #40 (409-1))

Orphan Drug Amendments of 1988 - Amends the Federal Food, Drug, and Cosmetic Act to require requests for designation as an orphan drug to be made before the submission of an application.

Requires manufacturers of orphan drugs which have been approved, certified, or licensed to notify the Secretary of Health and Human Services at least one year before discontinuing the production of the drug. Requires manufacturers or sponsors of an orphan drug which has not been approved, certified, or licensed while investigations are being conducted to notify the Secretary of any decision to discontinue pursuit of approval.

Makes financial assistance available for the development of medical devices and medical foods for rare diseases or conditions. Authorizes appropriations for FY 1988 through 1990.

Directs the Secretary to study and report to the appropriate congressional committees on whether the application of the provisions of the Federal Food, Drug, and Cosmetic Act relating to drugs for rare diseases and conditions and the Internal Revenue Code relating to tax credits is needed to encourage the development of such medical devices and foods for rare diseases and conditions.

Extends until February 1, 1989, the National Commission on Orphan Diseases' report to the Congress on the National Institutes of Health's work in the area or rare diseases and conditions.