Orphan Drug Amendments of 1985
Public Law 99-91 · S. 1147 · 99th Congress · began in the Senate
Signed by Ronald Reagan (R) on Aug 15, 1985 · Health
Sponsor: Sen. Orrin Hatch (R-UT)
Cosponsors (32): Sen. Ted Kennedy, Sen. Nancy Kassebaum,
Passage votes
- HouseVoice vote
- SenateVoice vote
Data notes
The final version of the law, as each chamber passed it. A chamber that passed it by voice vote or unanimous consent has no count. “Method not stated” means the record does not say how the chamber voted. Where the record has a member-by-member vote, the “Who voted for it” section shows who voted yea.
Summary
The Congressional Research Service’s plain-language summary of what the law does.
(Senate agreed to House amendment with an amendment)
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.
Authorizes the sponsor of an antibiotic drug for a rare disease to request the Secretary of Health and Human Services to provide written recommendations for the investigations which must be conducted before such drug will be certified for use.
Establishes a National Commission on Orphan Diseases (Commission). 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 the end of FY 1987, to the Secretary and to 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.
Amends the Developmental Disabilities Assistance and Bill of Rights Act to permit a State with an optional services waiver under the program of providing priority services to the disabled to continue such waiver on a limited basis through FY 1987.
Amends the Public Health Service Act to require the Secretary to carry out projects to encourage the regionalization of educational responsibilities of health professions schools through qualified area health education centers which are no longer eligible to receive assistance.
Committees
The record shows no committee referral for this bill.
Data notes
A committee links to its page only where it exists in the current Congress; older and renamed committees are named without a link.
Timeline
From introduction to signing, newest first: the committees, the floor and the president. 9 actions.
- Aug 15, 1985Became lawBecame law · Became Public Law No: 99-91.
- Became lawBecame law · Signed by President.
- Aug 7, 1985PresidentPresident · Presented to President.
- Jul 31, 1985Resolving differencesResolving differences · House Agreed to Senate Amendments to House Amendments by Voice Vote.
- Jul 25, 1985Resolving differencesResolving differences · Senate concurred in the House amendment with amendments (SP 546) by Voice Vote.
- Jun 18, 1985FloorFloor · Passed House (Amended) by Voice Vote.
- FloorFloor · Called up by House by Unanimous Consent.
- May 23, 1985FloorFloor · Passed Senate without amendment by Voice Vote.
- May 15, 1985IntroducedIntroduced · Introduced in the Senate
Data notes
Shows the introduction, each committee and subcommittee step the source dates (referral, hearings, markup, report, discharge), and the floor, conference, presidential and became-law steps. Calendar placements, messages between the chambers, amendments and committee report numbers are not shown for laws before the 108th Congress. Two entries the source lists twice are shown once.
Official record
The bill’s full text and every action, including introduction and committee steps, are on Congress.gov. Data through Oct 7, 2026.