[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5306 Introduced in House (IH)]






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 
 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

_______________________________________________________________________

                                 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 Representatives 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 sponsor of a drug intended 
for use for cancer (referred to in this subchapter as a `cancer drug') 
may request the Secretary to provide written recommendations for the 
nonclinical 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 reason 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 
recommendations for the nonclinical and clinical investigations which 
the Secretary believes, on the basis of information 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 regulation promulgate 
procedures for the implementation of subsections (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 section 505(b) for the drug, or the submission of an 
application 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 production of the drug at least one year before 
        discontinuance; 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 pursuit 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 respecting the 
designation of a drug under subsection (b) shall be made available to 
the public.
    ``(e) Regulations.--The Secretary shall by regulation promulgate 
procedures for the implementation of subsections (a) and (b).

``SEC. 577. MARKET PROTECTION FOR CANCER DRUGS.

    ``(a) In General.--Except as provided in subsection (b), if the 
Secretary approves an application filed pursuant to section 505 for a 
drug designated under section 576 as a cancer drug, or if the Secretary 
issues a license under section 351 of the Public Health Service Act for 
such a drug, the Secretary may not approve another application under 
section 505 or issue another license under section 351 of the Public 
Health Service Act for such drug for a person who is not the holder of 
such approved application or of such license until the expiration of 
seven years from the date of the approval of the approved application 
or the issuance of the license. Section 505(c)(2) does not apply to the 
refusal to approve an application under the preceding sentence.
    ``(b) Exception.--If an application filed pursuant to section 505 
is approved for a drug designated under section 576 as a cancer drug or 
if a license is issued under section 351 of the Public Health Service 
Act for such a drug, the Secretary may, during the seven-year period 
beginning on the date of the application approval or of the issuance of 
the license, approve another application under section 505 or issue a 
license under section 351 of the Public Health Service Act for such 
drug for cancer for a person who is not the holder of such approved 
application or of such license if--
            ``(1) the Secretary finds, after providing the holder 
        notice and opportunity for the submission of views, that in 
        such period the holder of the approved application or of the 
        license cannot assure the availability of sufficient quantities 
        of the drug to meet the needs of persons with the cancer 
        involved; or
            ``(2) such holder provides the Secretary in writing the 
        consent of such holder for the approval of other applications 
        or the issuance of other licenses before the expiration of such 
        seven-year period.

``SEC. 578. OPEN PROTOCOLS FOR INVESTIGATIONS OF CANCER DRUGS.

    ``If a drug is designated under section 576 as a cancer drug and if 
notice of a claimed exemption under section 505(i) or regulations 
issued thereunder is filed for such drug, the Secretary shall encourage 
the sponsor of such drug to design protocols for the drug which include 
persons with the cancer involved who need the drug to treat the cancer 
and who cannot be satisfactorily treated by available alternative 
drugs.''.

SEC. 3. ABBREVIATED APPLICATIONS FOR NEW DRUGS; NONPATENT MARKET 
              EXCLUSIVITY FOR CANCER DRUGS.

    Section 505(j)(5)(F)(ii) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355(j)(5)(F)(ii)) is amended--
            (1) by striking ``(ii)'' and inserting ``(ii)(I)''; and
            (2) by adding at the end the following subclause:
    ``(II) With respect to an application under subsection (b) for a 
drug referred to in subclause (I), in any case in which the drug is for 
use for cancer, the reference in such subclause to five years is deemed 
to be ten years, the reference to four years is deemed to be eight 
years, the reference to forty-eight months is deemed to be ninety-six 
months, and the reference to seven and one-half years is deemed to be 
twelve and one-half years.''.

SEC. 4. EXTENSION OF PATENT TERM ON CANCER DRUGS.

    Section 156(c) of title 35, United States Code, is amended by 
adding at the end the following flush sentence:
``Paragraphs (2) and (3) shall not apply in the case of a drug approved 
for use for cancer.''.
                                 <all>