[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 1878 Introduced in Senate (IS)]

114th CONGRESS
  1st Session
                                S. 1878

        To extend the pediatric priority review voucher program.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             July 28, 2015

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

_______________________________________________________________________

                                 A BILL


 
        To extend the pediatric priority review voucher program.

    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 ``Advancing Hope Act of 2015''.

SEC. 2. REAUTHORIZATION OF PROGRAM FOR PRIORITY REVIEW TO ENCOURAGE 
              TREATMENTS FOR RARE PEDIATRIC DISEASES.

    Section 529 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360ff) is amended--
            (1) in subsection (a)--
                    (A) by amending paragraph (3) to read as follows:
            ``(3) Rare pediatric disease.--The term `rare pediatric 
        disease' means any of the following:
                    ``(A) A disease that meets each of the following 
                criteria:
                            ``(i) The disease primarily affects 
                        individuals aged from birth to 18 years, 
                        including age groups often called neonates, 
                        infants, children, and adolescents.
                            ``(ii) The disease is a rare disease or 
                        condition, within the meaning of section 526.
                    ``(B) Any form of sickle cell disease.
                    ``(C) Any pediatric cancers.''; and
                    (B) in paragraph (4)--
                            (i) in subparagraph (E), by striking 
                        ``and'' at the end;
                            (ii) in subparagraph (F), by striking the 
                        period at the end and inserting ``; and''; and
                            (iii) by adding at the end the following:
                    ``(G) is for a drug or biological product for which 
                a priority review voucher has not been issued under 
                section 524 (relating to tropical disease products).'';
            (2) in subsection (b), by striking paragraph (5); and
            (3) in subsection (d)(2), in the second sentence, by 
        striking the period and inserting ``, but the sponsor of a drug 
        that intends to request a priority review voucher under this 
        section shall notify the Secretary of such intent upon 
        submission of an application under section 505 or section 351 
        of the Public Health Service Act that is the basis of such 
        request.''.
                                 <all>