PlainBillCongress, translated.Legislation. Context. Public interest.Placed on Senate Legislative Calendar under General Orders. Calendar No. 609.
Congressional Research Service
Version 00 · Introduced in Senate · Mar 24, 1994
Orphan Drug Act Amendments of 1994 - Amends the Federal Food, Drug, and Cosmetic Act to change from seven to four years the period of market exclusivity guaranteed to any approved orphan drug. Specifies that orphan drugs of "limited commercial potential," as defined by regulations to be issued by the Department of Health and Human Services, would qualify for an additional three years of exclusive marketing rights. Permits more than one company to put a particular orphan drug on the market in instances where both companies were working on the drug in roughly the same time frame. Provides for the withdrawal of exclusive marketing rights if the patient population for the approved treatment exceeds 200,000. Extends the authorization of the research grant program. Replaces the existing Orphan Products Board with an Office for Orphan Diseases and Conditions.
People & committees
Sen. Kassebaum, Nancy Landon [R-KS] · R–KS
Legislative record
A procedural vote is different from passage. Passage in one chamber does not establish enactment. Explore the glossary.
Placed on Senate Legislative Calendar under General Orders. Calendar No. 609.
Committee on Labor and Human Resources. Reported to Senate by Senator Kennedy without amendment. With written report No. 103-366. Additional views filed.
Committee on Labor and Human Resources. Reported to Senate by Senator Kennedy without amendment. With written report No. 103-366. Additional views filed.
Committee on Labor and Human Resources. Ordered to be reported without amendment favorably.
Read twice and referred to the Committee on Labor and Human Resources.
Sponsor introductory remarks on measure. (CR S3728-3729)
Introduced in Senate
Primary sources
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Source last updated: Aug 26, 2025. Consult Congress.gov for the current record.
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