I 108th CONGRESS 2d Session H. R. 5306 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.

1.

Short title

This Act may be cited as the New War on Cancer Act.

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: G

Cancer drugs

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).

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).

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.

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.

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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..

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..