[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[S. 606 Introduced in Senate (IS)]

112th CONGRESS
  1st Session
                                 S. 606

   To amend the Federal Food, Drug, and Cosmetic Act to improve the 
priority review voucher incentive program relating to tropical and rare 
                          pediatric diseases.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             March 17, 2011

Mr. Casey (for himself, Mr. Brown of Massachusetts, Mr. Brown of Ohio, 
Mr. Isakson, and Mr. Franken) introduced the following bill; which was 
 read twice and referred to the Committee on Health, Education, Labor, 
                              and Pensions

_______________________________________________________________________

                                 A BILL


 
   To amend the Federal Food, Drug, and Cosmetic Act to improve the 
priority review voucher incentive program relating to tropical and rare 
                          pediatric diseases.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE; REFERENCES.

    (a) Short Title.--This Act may be cited as the ``Creating Hope Act 
of 2011''.
    (b) References.--Wherever in this Act an amendment is expressed in 
terms of an amendment to a section or other provision, the reference 
shall be considered to be made to a section or other provision of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).

SEC. 2. IMPROVEMENT OF THE TROPICAL DISEASE VOUCHER PROGRAM.

    (a) Heading.--The heading of section 524 (21 U.S.C. 360n) is 
amended to read as follows: ``priority review to encourage innovative 
treatments for tropical diseases and rare pediatric diseases''.
    (b) Definitions.--Section 524(a) (21 U.S.C. 360n(a)) is amended--
            (1) by redesignating paragraphs (3) and (4) as paragraphs 
        (6) and (7), respectively;
            (2) by redesignating paragraphs (1) and (2) as paragraphs 
        (2) and (3), respectively;
            (3) by inserting after ``In this section:'', the following:
            ``(1) Innovative treatment.--The term `innovative 
        treatment' means--
                    ``(A) a human drug that is the subject of an 
                application submitted under section 505(b)(1), if that 
                drug contains no active ingredient (including any ester 
                or salt of the active ingredient) that has been 
                previously approved in any other application under 
                section 505(b)(1), 505(b)(2), or 505(j) or section 351 
                of the Public Health Service Act; or
                    ``(B) a biological product that is the subject of 
                an application submitted under section 351(a) of the 
                Public Health Service Act, if that biological product--
                            ``(i) does not have the same structure as a 
                        biological product that has been previously 
                        licensed in any other application under 
                        subsection (a) or (k) of section 351 of the 
                        Public Health Service Act or approved under 
                        section 505 of this Act; and
                            ``(ii) is not biosimilar, within the 
                        meaning of section 351(i) of the Public Health 
                        Service Act, to a biological product that has 
                        been previously licensed in any other 
                        application under subsection (a) or (k) of 
                        section 351 of the Public Health Service Act or 
                        approved under section 505 of this Act.'';
            (4) in paragraph (3), as so redesignated, by inserting ``or 
        rare pediatric disease product application'' after ``tropical 
        disease product application'' each place that phrase appears;
            (5) by inserting after paragraph (3) the following:
            ``(4) Rare pediatric disease.--The term `rare pediatric 
        disease' means a disease that meets each of the following 
        criteria:
                    ``(A) The disease is recognized in the medical 
                community as affecting a pediatric population.
                    ``(B) The disease is a rare disease or condition, 
                within the meaning of section 526.
            ``(5) Rare pediatric disease product application.--The term 
        `rare pediatric disease product application' means a human drug 
        application, as defined in section 735(1)--
                    ``(A) for prevention or treatment of a rare 
                pediatric disease;
                    ``(B) that the Secretary deems eligible for 
                priority review;
                    ``(C) that is for an innovative treatment;
                    ``(D) that relies on clinical data derived from 
                studies examining a pediatric population and dosages of 
                the drug intended for that population; and
                    ``(E) that does not seek approval for an adult 
                indication in the original rare pediatric disease 
                product application.'';
            (6) in paragraph (6), as so redesignated--
                    (A) by redesignating subparagraph (Q) as 
                subparagraph (R); and
                    (B) by inserting after subparagraph (P) the 
                following:
                    ``(Q) Chagas Disease.''; and
            (7) by amending paragraph (7), as so redesignated, to read 
        as follows:
            ``(7) Tropical disease product application.--The term 
        `tropical disease product application' means a human drug 
        application, as defined in section 735(1)--
                    ``(A) for prevention or treatment of a tropical 
                disease;
                    ``(B) that the Secretary deems eligible for 
                priority review;
                    ``(C) that is for an innovative treatment; and
                    ``(D) that the sponsor affirms in the application 
                is for a drug that has not been approved for commercial 
                marketing for any tropical disease indication by a 
                government authority outside of the United States for 
                more than 24 months before the tropical disease product 
                application is submitted.''.
    (c) Rules Regarding Use and Transfer of Priority Review Vouchers.--
Section 524(b) (21 U.S.C. 360n(b)) is amended--
            (1) in paragraph (1), by inserting ``or rare pediatric 
        disease product application'' after ``tropical disease product 
        application'' each place that phrase appears;
            (2) by amending paragraph (2) to read as follows:
            ``(2) Transferability.--
                    ``(A) In general.--The sponsor of a tropical 
                disease product application or rare pediatric disease 
                product application that receives a priority review 
                voucher under this section may transfer (including by 
                sale) the entitlement to such voucher. There is no 
                limit on the number of times a priority review voucher 
                may be transferred before such voucher is used.
                    ``(B) Conditions of transfer.--If a sponsor 
                transfers a priority review voucher after such sponsor 
                has provided notification to the Secretary under 
                paragraph (4)(A) of the intent of such sponsor to use 
                the voucher, the transfer shall be subject to the 
                provisions of subparagraphs (B) and (C) of paragraph 
                (4).
                    ``(C) Notification of transfer.--The person to whom 
                a voucher is transferred under paragraph (4)(B)(i) 
                shall notify the Secretary of such change in ownership 
                of the voucher not later than 30 days after such 
                transfer.'';
            (3) by amending paragraph (3) to read as follows:
            ``(3) Limitation for prior applications.--
                    ``(A) Tropical disease product applications.--A 
                sponsor of a tropical disease product application may 
                not receive a priority review voucher under this 
                section if the tropical disease product application was 
                submitted to the Secretary prior to September 27, 2007.
                    ``(B) Rare pediatric disease product 
                applications.--A sponsor of a rare pediatric disease 
                product application may not receive a priority review 
                voucher under this section if the rare pediatric 
                disease product application was submitted to the 
                Secretary prior to the date that is 90 days after the 
                date of enactment of the Creating Hope Act of 2011.''; 
                and
            (4) by amending paragraph (4) to read as follows:
            ``(4) Notification.--
                    ``(A) Timing.--At least 90 days before the date on 
                which a human drug application for which the sponsor 
                intends to use a priority review voucher is submitted, 
                the sponsor of such human drug application shall notify 
                the Secretary of the intent of such sponsor to submit 
                the human drug application.
                    ``(B) Transfer of voucher after notification.--
                            ``(i) In general.--The sponsor of a human 
                        drug application that provides notification of 
                        the intent of such sponsor to use the voucher 
                        for the human drug application may transfer the 
                        voucher within 1 year after such notification 
                        is provided, if such sponsor has not yet 
                        submitted the human drug application described 
                        in the notification.
                            ``(ii) Exception.--The person to whom a 
                        voucher is transferred under clause (i) 
                        (referred to in this paragraph as the 
                        `transferee') shall give notification of the 
                        intent of such transferee to use the voucher in 
                        accordance with this subsection, unless--
                                    ``(I) the transferee uses the 
                                voucher for a human drug application 
                                including the same indications as the 
                                human drug application described in the 
                                transferor's notification; and
                                    ``(II) the transferee notifies the 
                                Secretary within 30 days of the 
                                transfer of the intent of such 
                                transferee to use the voucher for such 
                                purpose.
                            ``(iii) Internal transfer.--If the sponsor 
                        transfers a voucher internally for use with a 
                        drug application including one or more 
                        indications that were not included in the drug 
                        application that was the subject of the 
                        notification of such sponsor, the sponsor shall 
                        notify the Secretary of the transfer in 
                        accordance with this subsection.
                    ``(C) Fee due upon notification; credit for 
                transferred voucher.--
                            ``(i) Due upon notification.--The 
                        notification under this subsection shall be a 
                        legally binding commitment to pay for the user 
                        fee to be assessed in accordance with this 
                        section. Such fee shall be payable by the 
                        sponsor upon the submission by such sponsor of 
                        such notification.
                            ``(ii) Credit.--If a sponsor pays a user 
                        fee upon providing notification of the intent 
                        of such sponsor to use a priority review 
                        voucher, but later transfers the voucher for 
                        which such sponsor gave notification, the 
                        Secretary shall credit the user fees paid to 
                        the next human drug application for which a 
                        sponsor provides notification of the intent of 
                        such sponsor to use the same transferred 
                        voucher.
                            ``(iii) Difference in fee.--The Secretary 
                        may require a sponsor using a transferred 
                        voucher to pay the difference between the 
                        credit associated with the transferred voucher 
                        and the user fee prevailing at the time the 
                        sponsor submits notification of the intent of 
                        such sponsor to use the transferred voucher. 
                        This provision does not apply in cases where a 
                        transferee is exempted from submitting 
                        notification under this paragraph.''.
    (d) Payment.--Section 524(c)(4) (21 U.S.C. 360n(c)(4)) is amended--
            (1) in subparagraph (A), by striking ``submission of a 
        human drug application under section 505(b)(1) or section 351 
        of the Public Health Services Act for which the priority review 
        voucher is used.'' and inserting ``notification by a sponsor of 
        the intent of such sponsor to use the voucher, as specified in 
        subsection (b)(4)(A). All other user fees associated with the 
        human drug application shall be due as required by the 
        Secretary or under applicable law.''; and
            (2) in subparagraph (C), by striking the period at the end 
        and inserting ``, except as specified in subsection 
        (b)(4)(C).''.
    (e) Designation Process; Product Implementation Requirement.--
Section 524 (21 U.S.C. 360n) is amended by adding at the end the 
following new subsections:
    ``(e) Designation Process.--
            ``(1) Designation of rare pediatric diseases.--
                    ``(A) In general.--Upon the request of the 
                manufacturer or the sponsor of a new drug, the 
                Secretary may designate that the new drug is for a rare 
                pediatric disease. Such a request for designation, if 
                sought, shall be made when requesting designation of 
                orphan disease status under section 526 or fast-track 
                designation under section 506. Requesting designation 
                of rare pediatric disease status under this paragraph 
                is not a prerequisite to receiving a priority review 
                voucher.
                    ``(B) Determination by secretary.--Not later than 
                60 days after a request is submitted under subparagraph 
                (A), the Secretary shall determine whether the disease 
                or condition that is the subject of such request is a 
                rare pediatric disease.
            ``(2) Designation of innovative treatments.--
                    ``(A) In general.--Upon the request of the 
                manufacturer or the sponsor of a new drug, the 
                Secretary may designate that a new drug is an 
                innovative treatment. Such a request for designation, 
                if sought, shall be made when requesting fast-track 
                designation under section 506. Requesting designation 
                that a new drug is an innovative treatment is not a 
                prerequisite to receiving a priority review voucher.
                    ``(B) Determination by secretary.--Not later than 
                60 days after a request is submitted under subparagraph 
                (A), the Secretary shall determine whether the new drug 
                that is the subject of such request is an innovative 
                treatment.
    ``(f) Product Implementation for Rare Pediatric Disease Products.--
            ``(1) In general.--The Secretary shall deem a rare 
        pediatric disease product application incomplete if such 
        application does not contain a description of the plan of the 
        sponsor of such application to market the product in the United 
        States.
            ``(2) Good faith intent to market.--
                    ``(A) Good faith intent.--The Secretary may refuse 
                to issue a priority review voucher upon the approval of 
                a rare pediatric disease product application if the 
                Secretary finds that the sponsor of such application 
                lacks a good faith intention to market the product in 
                the United States. The Secretary may consider any fact 
                relevant to this determination, including the history 
                of such sponsor of producing rare pediatric disease 
                products for which such sponsor received a priority 
                review voucher, orphan drugs for which the sponsor 
                received exclusivity under section 527, or pediatric 
                drugs for which the sponsor received an additional 6 
                months of exclusivity under section 505A.
                    ``(B) Presumption.--The sponsor may establish a 
                presumption of good faith by demonstrating that such 
                sponsor has allocated sufficient resources or otherwise 
                arranged for the production (by the sponsor or by 
                another manufacturer) of the rare pediatric disease 
                product in a manner sufficient to meet the expected 
                demand for the product during the 5-year period 
                following approval of the application.
                    ``(C) Guidance.--If the Secretary requires sponsors 
                seeking a priority review voucher to demonstrate a good 
                faith intent to market the rare pediatric disease 
                product in the United States, the Secretary shall first 
                issue a guidance document setting forth the required 
                evidentiary support necessary to demonstrate such a 
                good faith intent.
            ``(3) Postapproval production report.--
                    ``(A) Report required.--The sponsor of an approved 
                rare pediatric disease product shall submit a report to 
                the Secretary not later than 5 years after the approval 
                of the applicable rare pediatric disease product 
                application. Such report shall provide the following 
                information, with respect to each of the first 4 years 
                after approval of such product:
                            ``(i) The estimated population in the 
                        United States suffering from the rare pediatric 
                        disease.
                            ``(ii) The estimated demand in the United 
                        States for such rare pediatric disease product.
                            ``(iii) The actual amount of such rare 
                        pediatric disease product distributed in the 
                        United States.
                    ``(B) Publication upon failure to demonstrate good 
                faith effort to market.--The Secretary may publish the 
                results of a report submitted under subparagraph (A) in 
                the Federal Register if the Secretary finds that the 
                sponsor that submitted such report has not made a good 
                faith effort to meet the demand in the United States 
                for the product that is the subject of such report 
                during each of the first 4 years after approval of such 
                product.
    ``(g) Production Report for Tropical Disease Products.--
            ``(1) Report required.--The sponsor of an approved tropical 
        disease product shall submit a report to the Secretary not 
        later than 5 years after the approval of the applicable rare 
        tropical disease product application. Such report shall provide 
        the following information, with respect to each of the first 4 
        years after approval of such product:
                    ``(A) The estimated global population suffering 
                from the tropical disease.
                    ``(B) The estimated global demand for such tropical 
                disease product.
                    ``(C) The actual amount of such tropical disease 
                product distributed globally.
            ``(2) Publication upon failure to demonstrate good faith 
        effort to market.--The Secretary may publish the results of a 
        report submitted under paragraph (1) in the Federal Register if 
        the Secretary finds that the sponsor that submitted such report 
        has not made a good faith effort to meet the global demand for 
        the product that is the subject of such report during each of 
        the first 4 years after approval of such product.
    ``(h) Notice of Issuance and Use of Voucher.--The Secretary shall 
publish a notice in the Federal Register and on the Web site of the 
Food and Drug Administration not later than 30 days after the 
occurrence of each of the following:
            ``(1) The Secretary issues a priority review voucher under 
        this section.
            ``(2) A sponsor submits a human drug application for which 
        such sponsor uses a priority review voucher.
    ``(i) Eligibility for Other Programs.--A sponsor who seeks a 
priority review voucher under this section may participate in any other 
incentive program, including the programs the Secretary has implemented 
under this Act, if the sponsor meets the applicable criteria of such 
other incentive program.
    ``(j) Relation to Other Provisions.--This provisions of this 
section shall supplement, not supplant, any other provisions of this 
Act or the Public Health Service Act that encourage the development of 
drugs for tropical diseases and rare pediatric diseases.''.
    (f) Conforming Amendment.--Section 740(b) of the Agricultural, 
Rural Development, Food and Drug Administration, and Related Agencies 
Appropriations Act, 2010 (21 U.S.C. 360aa note) is amended by striking 
``(a)(3)'' each place such term appears and inserting ``(a)(6)''.

SEC. 3. EFFECTIVE DATE.

    This Act (and the amendments made by this Act) shall take effect on 
the date that is 90 days after the date of enactment of this Act.
                                 <all>