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HR 5306 108th Congress House

New War on Cancer Act

Official title: To amend the Federal Food, Drug, and Cosmetic Act with respect to market exclusivity for cancer drugs, and to amend title 35, United States Code, to provide fo… Show full official titleShow less

Official title: To amend the Federal Food, Drug, and Cosmetic Act with respect to market exclusivity for cancer drugs, and to amend title 35, United States Code, to provide for the extension of the patent term on such drugs equal to the regulatory review period for such drugs.

Introduced: October 8, 2004 Introduced by: Carter, John R. Republican · Texas See on congress.gov
Health Administrative procedureCancerClinical trialsCommerce
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Department of Health and Human ServicesDrug approvalsDrug industryDrugsGovernment Operations and PoliticsGovernment paperworkIntellectual propertyLawLicensesPatentsPharmaceutical researchScience, Technology, Communications
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This bill died when the 108th Congress ended
It never became law before the 108th Congress (2003–2004) adjourned, and bills don't carry over to the next Congress. It would have to be reintroduced. You can still save it for reference, but it won't receive updates.
 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
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 Latest action November 5, 2004

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

 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.

 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 4
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APA
U.S. Congress. (2026). H.R. 5306: New War on Cancer Act. 108th Congress. Open America. https://openamerica.io/bill/108-HR-5306/
MLA
"H.R. 5306: New War on Cancer Act." 108th Congress, 2026, Open America, https://openamerica.io/bill/108-HR-5306/.
Bluebook (legal)
H.R. 5306, 108th Cong. (2026), https://openamerica.io/bill/108-HR-5306/.
Markdown link
[H.R. 5306: New War on Cancer Act](https://openamerica.io/bill/108-HR-5306/)
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