Orphan Drug Act Amendments of 1994
Bill journey · stage 1 of 5
Just introduced
What it doesSummary 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.
What just happenedAug 5, 1994
For Further Action See H.R.4865.
Who’s behind it
- Introduced in HouseMar 24, 1994
- Aug 5, 1994CommitteeH19100
For Further Action See H.R.4865.
Energy and Commerce Committee - Jul 29, 1994CommitteeH23000
Forwarded by Subcommittee to Full Committee (Amended) by the Yeas and Nays: 15 - 10.
Health and Environment Subcommittee - Jul 29, 1994CommitteeH22000
Subcommittee Consideration and Mark-up Session Held.
Health and Environment Subcommittee - Jun 16, 1994CommitteeH21000
Subcommittee Hearings Held.
Health and Environment Subcommittee - Apr 26, 1994CommitteeH11000
Referred to the Subcommittee on Health and the Environment.
Health and Environment Subcommittee - Mar 24, 1994IntroReferralH11100
Referred to the House Committee on Energy and Commerce.
Energy and Commerce Committee - Mar 24, 1994IntroReferralB00100
Sponsor introductory remarks on measure. (CR E561)
- Mar 24, 1994IntroReferralIntro-H
Introduced in House
- Mar 24, 1994IntroReferral1000
Introduced in House