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United States · Bill · HR

H.R. 4865 (103rd)

Orphan Drug Act Amendments of 1994

openUnited States· United States Congress· EN

Introduced

1 August 1994

Last action

—

Status

Placed on the Union Calendar, Calendar No. 410.

Sponsors

—

Subjects

Discovery layer

Source updated

5 February 2024

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Summary

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 (HHS) (based on total sales revenue for such drug during the four-year exclusivity period or other factors identified by the Secretary of HHS), 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.

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6 official files

Reported in House (text)

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