PlainBillCongress, translated.Legislation. Context. Public interest.Congressional Research Service
Version 00 · Introduced in House · 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
Rep. Waxman, Henry A. [D-CA-29] · D–CA
Legislative record
A procedural vote is different from passage. Passage in one chamber does not establish enactment. Explore the glossary.
For Further Action See H.R.4865.
Forwarded by Subcommittee to Full Committee (Amended) by the Yeas and Nays: 15 - 10.
Subcommittee Consideration and Mark-up Session Held.
Subcommittee Hearings Held.
Referred to the Subcommittee on Health and the Environment.
Referred to the House Committee on Energy and Commerce.
Sponsor introductory remarks on measure. (CR E561)
Introduced in House
Introduced in House
Primary sources
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Source last updated: Jun 3, 2026. Consult Congress.gov for the current record.
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