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Orphan Drug Amendments of 1985

Introduced: May 15, 1985 See on congress.gov
 Everywhere this bill has been 16 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Aug 15, 1985
Became Public Law No: 99-91.
Aug 15, 1985
Signed by President.
Aug 7, 1985
Presented to President.
Aug 7, 1985
Measure Signed in Senate.
Jul 31, 1985
House Agreed to Senate Amendments to House Amendments by Voice Vote.
Jul 31, 1985
Resolving differences -- House actions: House Agreed to Senate Amendments to House Amendments by Voice Vote.
Jul 25, 1985
Senate concurred in the House amendment with amendments (SP 546) by Voice Vote.
Jul 25, 1985
Resolving differences -- Senate actions: Senate concurred in the House amendment with amendments (SP 546) by Voice Vote.
Jul 25, 1985
Considered by Senate.
Jun 18, 1985
Passed House (Amended) by Voice Vote.
Jun 18, 1985
Passed/agreed to in House: Passed House (Amended) by Voice Vote.
Jun 18, 1985
Called up by House by Unanimous Consent.
May 23, 1985
Passed Senate without amendment by Voice Vote.
May 23, 1985
Passed/agreed to in Senate: Passed Senate without amendment by Voice Vote.
May 15, 1985
Introduced in the Senate, read twice. Placed on Senate Legislative Calendar under General Orders. Calendar No. 135.
May 15, 1985
Introduced in Senate
 Plain-English summary Congressional Research Service

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. Requires the Commission to assess the activities of the National Institutes of Health, the Alcohol, Drug Abuse, and Mental Health Administration, the Food and Drug 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 preclinical and human clinical testing of orphan drugs. Authorizes appropriations for such grants and contracts for FY 1986 through 1988.

Makes technical corrections to the Departments of Labor, Health and Human Services, Education and Related Appropriation Act, 1985 in order to allow the expenditure of funds for personnel training under the Education of the Handicapped Act until September 30, 1985.

What's happening now August 15, 1985

Became Public Law No: 99-91.