HR 3930
102th Congress
House
Health
Drug industry
Drugs
Government paperwork
Licenses
Orphan drugs
To revise the orphan drug exclusivity provisions of the Federal Food, Drug, and Cosmetic Act.
Introduced: November 25, 1991
See on congress.gov
Everywhere this bill has been
3 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Jan 14, 1992
Referred to the Subcommittee on Health and the Environment.
Nov 25, 1991
Referred to the House Committee on Energy and Commerce.
Nov 25, 1991
Introduced in House
Plain-English summary
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's happening now
Referred to the Subcommittee on Health and the Environment.
Committees of jurisdiction
2
Cosponsors
1