I 
108TH CONGRESS 
2D SESSION 
H. R. 5306 
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. 
IN THE HOUSE OF REPRESENTATIVES 
OCTOBER 8, 2004 
Mr. CARTER introduced the following bill; which was referred to the Com-
mittee 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 juris-
diction of the committee concerned 
A BILL 
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. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘New War on Cancer 
Act’’.
SEC. 2. NONPATENT MARKET EXCLUSIVITY FOR CANCER 
DRUGS. 
Chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 351 et seq.) is amended by adding at the 
end the following subchapter: 
‘‘Subchapter G—Cancer Drugs 
‘‘SEC. 575. RECOMMENDATIONS FOR INVESTIGATIONS OF 
CANCER DRUGS. 
‘‘(a) REQUEST FOR RECOMMENDATIONS.—The spon-
sor of a drug intended for use for cancer (referred to in 
this subchapter as a ‘cancer drug’) may request the Sec-
retary to provide written recommendations for the nonclin-
ical and clinical investigations which must be conducted 
with the drug before— 
‘‘(1) it may be approved for use for cancer 
under section 505; or 
‘‘(2) if the drug is a biological product, it may 
be licensed for use for cancer under section 351 of 
the Public Health Service Act. 
‘‘(b) RECOMMENDATIONS.—If the Secretary has rea-
son to believe that a drug for which a request is made 
under subsection (a) is a cancer drug, the Secretary shall 
provide the person making the request written rec-
ommendations for the nonclinical and clinical investiga-
tions which the Secretary believes, on the basis of informa-
tion available to the Secretary at the time of the request, 
would be necessary for— 
‘‘(1) approval of such drug for use for cancer 
under section 505; or 
‘‘(2) licensing of such drug for use for cancer 
under section 351 of the Public Health Service Act. 
‘‘(c) REGULATIONS.—The Secretary shall by regula-
tion promulgate procedures for the implementation of sub-
sections (a) and (b). 
‘‘SEC. 576. DESIGNATION OF CANCER DRUGS. 
‘‘(a) REQUEST FOR DESIGNATION.—The sponsor of 
a drug may request the Secretary to designate the drug 
as a cancer drug. A request for designation of a drug shall 
be made before the submission of an application under sec-
tion 505(b) for the drug, or the submission of an applica-
tion for licensing of the drug under section 351 of the 
Public Health Service Act. Such a request shall contain 
the consent of the applicant to notice being given by the 
Secretary under subsection (c) respecting the designation 
of the drug. 
‘‘(b) DESIGNATION.—In the case of a drug for which 
a request is submitted under subsection (a), the Secretary 
shall designate the drug as a cancer drug if the Secretary 
finds that the drug is being or will be investigated for use 
for cancer.
‘‘(c) CONDITIONS.—A designation of a drug under 
subsection (b) shall be subject to the condition that— 
‘‘(1) after an application is approved for the 
drug under section 505(b) or a license is issued for 
the drug under section 351 of the Public Health 
Service Act, the manufacturer of the drug will notify 
the Secretary of any discontinuance of the produc-
tion of the drug at least one year before discontinu-
ance; and 
‘‘(2) before an application is approved for the 
drug under section 505(b) or a license is issued for 
the drug under section 351 of the Public Health 
Service Act, the sponsor of the drug will notify the 
Secretary of any decision to discontinue active pur-
suit of approval of an application under section 
505(b) or approval of a license under section 351 of 
the Public Health Service Act. 
‘‘(d) PUBLIC AVAILABILITY OF NOTICE.—Notice re-
specting the designation of a drug under subsection (b) 
shall be made available to the public. 
‘‘(e) REGULATIONS.—The Secretary shall by regula-
tion promulgate procedures for the implementation of sub-
sections (a) and (b).