H.R. 229099th CongressHouse Bill

Orphan Drug Amendments of 1985

Introduced in the HouseDead

This bill died when its Congress ended.

Bills don't carry over between Congresses. Without re-introduction in a new session, it cannot advance.

Orphan Drug Amendments of 1985 - Amends the Federal Food, Drug, and Cosmetic Act to repeal the requirement that exclusive marketing rights may only be granted to an orphan drug (a drug used in the treatment of a rare disease or condition) if the drug is not patentable. Establishes a National Commission on Orphan Diseases to assess the activities of the National Institutes of Health, the Alcohol, Drug Abuse, and Mental Health Administration, other public agencies, and private entities in connection with: (1) basic research relating to rare diseases; (2) the use in research on rare diseases of knowledge developed in other research; (3) applied and clinical research relating to the prevention, diagnosis, and treatment of rare diseases; and (4) the dissemination of knowledge developed in research relating to rare diseases. Requires the Commission to submit a report by September 30, 1987, to the Secretary of Health and Human Services and to each House of the Congress containing the Commission's findings, conclusions, and recommendations. Makes funds available to the Commission. Terminates the Commission 90 days after the date of such report. Amends the Orphan Drug Act to allow Federal grants and contracts for animal and human clinical testing of orphan drugs. Authorizes appropriations for such grants and contracts for FY 1986 through 1988.

Introduced Apr 30, 1985
1
Introduced

Filed in the House

2
Passed House
3
Passed Senate
4
Became Law

This house bill has been filed and is working its way through Congress. It will need to pass both the House and the Senate, then be signed by the President to become law.

Who introduced this

HW

Henry Waxman

Democrat

U.S. Representative · CA-24

1 cosponsor — all Republican

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