Advancing Hope Act of 2015

Bill: 114-hr-1537
Sponsor: full_name: Rep. Butterfield, G. K. [D-NC-1]
Introduced: 2015-03-23
Policy area: Health
Subjects: Blood and blood diseases

Cancer

Child health

Drug safety, medical device, and laboratory regulation

Drug therapy

Hereditary and development disorders

Infectious and parasitic diseases

World health
Latest action: action_date: 2015-03-27
text: Referred to the Subcommittee on Health.

Summaries:
action_date: 2015-03-23
action_desc: Introduced in House
text: <p><b>Advancing Hope Act of 2015</b></p> <p>This bill amends the Federal Food, Drug, and Cosmetic Act to expand the priority review voucher program for rare pediatric diseases to include treatments for sickle cell disease and pediatric cancers. </p> <p>The voucher program is extended by removing the provision terminating the program one year after the Food and Drug Administration's (FDA's) issuance of three rare pediatric disease vouchers. </p> <p>A voucher may not be issued for a rare pediatric disease product if a voucher was issued for the product as a tropical disease product.</p> A tropical disease voucher may not be issued for a product that was approved, over two years before submitting an application to the FDA, for commercial marketing by a foreign government to treat a tropical disease.

tv_txt: I 114th CONGRESS 1st Session H. R. 1537 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.

1. Short title This Act may be cited as the Advancing Hope Act of 2015 . 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). 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; .