To revise the orphan drug exclusivity provisions of the Federal Food, Drug, and Cosmetic Act.
Bill journey · stage 2 of 5
Under committee review
What it doesSummary introduced in house (Nov 25, 1991)
Amends provisions of the Federal Food, Drug, and Cosmetic Act (FDCA) relating to drugs for rare diseases or conditions (commonly referred to as orphan drugs) to require the approval of an application under FDCA new drug provisions, a certification under FDCA antibiotic drug provisions, or a license under provisions of the Public Health Service Act regulating biologic products when the current holder of such an application, certification, or license has had: (1) cumulative dollar sales of the drug exceeding specified amounts; and (2) cumulative research and development costs for the drug not exceeding certain amounts.
What just happenedJan 14, 1992
Referred to the Subcommittee on Health and the Environment.
Who’s behind it
- Jan 14, 1992CommitteeH11000
Referred to the Subcommittee on Health and the Environment.
Health and Environment Subcommittee - Nov 25, 1991IntroReferralH11100
Referred to the House Committee on Energy and Commerce.
Energy and Commerce Committee - Nov 25, 1991IntroReferralIntro-H
Introduced in House
- Nov 25, 1991IntroReferral1000
Introduced in House