Orphan Drug Amendments of 1987

Summary

Orphan Drug Amendments of 1987 - Amends the Federal Food, Drug, and Cosmetic Act to authorize the Secretary of Health and Human Services to approve an application for a license during the usual seven-year moratorium on second applications for licensing drugs for rare diseases or conditions (orphan drugs) designated under the Public Health Service Act if the second application contains reports of clinical investigations conducted by the applicant which are essential to the approval of the application and the applicant has not relied without permission upon investigations conducted by or for the license holder. Requires requests for designation as an orphan drug to be made before the submission of an application. Requires manufacturers of such drugs, if investigations are being conducted before an application has been approved, to notify the Secretary if the manufacturer decides to discontinue pursuit of approval of an application. Makes financial assistance available for the developing of medical devices and medical foods. Authorizes appropriations for FY 1988 through 1990. Directs the Secretary to study and report to the appropriate congressional committees on whether other aspects of the orphan drug law should be expanded to encourage the development of medical devices and foods. Extends until February 1, 1989, the date by which the National Commission on Orphan Diseases shall report to the Congress on the National Institutes of Health's work in the area of rare diseases and conditions.

This text is taken from the official record. PoliticalRepo does not editorialize.

Timeline

No timeline events have been ingested for this record yet.

Votes

No vote records are attached yet.

Versions

No version snapshots stored. Document URLs remain at the source.

Documents

1 official file

• Introduced in House

  summary · EN · 29 September 1987

  Open at official source

Sponsors

No sponsors or actors listed by the source.

Related records

No cross-record relationships stored yet.