[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1537 Introduced in House (IH)]

114th CONGRESS
  1st Session
                                H. R. 1537

  To amend the Federal Food, Drug, and Cosmetic Act to reauthorize a 
 program of priority review to encourage treatments for rare pediatric 
                   diseases, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             March 23, 2015

Mr. Butterfield (for himself, Mr. McCaul, Mr. Van Hollen, Mr. Kelly of 
 Pennsylvania, and Mr. Cohen) introduced the following bill; which was 
            referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
  To amend the Federal Food, Drug, and Cosmetic Act to reauthorize a 
 program of priority review to encourage treatments for rare pediatric 
                   diseases, and for other purposes.

    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)(A)--
                            (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).''; 
                and
            (2) in subsection (b), by striking paragraph (5).

SEC. 3. LIMITATION ON PRIORITY REVIEW VOUCHERS FOR TROPICAL DISEASE 
              PRODUCTS.

    Subparagraph (A) of section 524(a)(4) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360n(a)(4)) is amended--
            (1) in clause (i), by striking ``and'' at the end;
            (2) in clause (ii), by inserting ``and'' at the end; and
            (3) by adding at the end the following:
                            ``(iii) contains an assurance (satisfactory 
                        to the Secretary) that the drug for which the 
                        application is submitted 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 application is submitted;''.
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