Skip to main content
HR 5306 108th Congress House Health Administrative procedure Cancer Clinical trials Commerce Department of Health and Human Services Drug approvals Drug industry Drugs Government Operations and Politics Government paperwork Intellectual property Law Licenses Patents Pharmaceutical research Science, Technology, Communications

New War on Cancer Act

Introduced: October 8, 2004 Introduced by: Carter, John R. Republican · Texas See on congress.gov
 Everywhere this bill has been 4 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Nov 5, 2004
Referred to the Subcommittee on Courts, the Internet, and Intellectual Property.
Oct 8, 2004
Referred to the Subcommittee on Health.
Oct 8, 2004
Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Oct 8, 2004
Introduced in House
 Plain-English summary Congressional Research Service

New War on Cancer Act - Allows the sponsor of a drug intended for use for cancer to request the Secretary of Health and Human Services to: (1) provide written recommendations for investigations which must be conducted before approval of a drug or before licensure of a biological product for use for cancer; and (2) designate such drug as a cancer drug before the submission of a request for approval or licensing. Requires the Secretary to designate such drug as a cancer drug if the drug is being or will be investigated for use for cancer. Prohibits the Secretary from approving another application or issuing another license for a designated cancer drug for a person who is not the holder of the approved application or license until the expiration of seven years, with certain exceptions.

Requires the Secretary to encourage the sponsor of a designated cancer drug approved for investigational use to design protocols for the drug that include persons with the cancer involved who cannot be satisfactorily treated by alternative drugs.

Extends the time during which an application for approval of drug with the same active ingredient as an approved cancer drug may not be approved.

Excludes approved cancer drugs from time limits imposed on the maximum length of a patent.

What's happening now November 5, 2004

Referred to the Subcommittee on Courts, the Internet, and Intellectual Property.

 Committees of jurisdiction 4