Adding Ebola to the FDA Priority Review Voucher Program Act

Bill: 113-hr-5729
Sponsor: full_name: Rep. Blackburn, Marsha [R-TN-7]
Introduced: 2014-11-18
Policy area: Health
Subjects: Drug safety, medical device, and laboratory regulation

Drug therapy

Infectious and parasitic diseases
Latest action: action_date: 2014-11-21
text: Referred to the Subcommittee on Health.

Summaries:
action_date: 2014-11-18
action_desc: Introduced in House
text: <p>Adding Ebola to the FDA Priority Review Voucher Program Act - Amends the Federal Food, Drug, and Cosmetic Act to add filoviruses, a family of viruses that includes the Ebola virus, to the list of tropical diseases under the priority review voucher program, which awards vouchers to sponsors of human drug applications that are approved to prevent or treat tropical diseases. (A voucher entitles the holder to have a future human drug application acted upon by the Food and Drug Administration (FDA) within six months.)</p> <p>Changes the process by which infectious diseases that do not significantly impact developed nations and disproportionately affect poor and marginalized populations can be designated as tropical diseases from rulemaking to order of the Secretary of Health and Human Services (HHS).</p> <p>Allows priority review vouchers to be transferred between sponsors of human drug applications any number of times.</p> Reduces from 365 days to 90 days the advance notice required before submitting a human drug application subject to a priority review voucher.

tv_txt: I 113th CONGRESS 2d Session H. R. 5729 IN THE HOUSE OF REPRESENTATIVES November 18, 2014 Mrs. Blackburn (for herself, Mr. Gene Green of Texas , Mr. Butterfield , Mr. McCaul , and Mr. Fleischmann ) introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To expand the program of priority review to encourage treatments for tropical diseases.

1. Short title This Act may be cited as the Adding Ebola to the FDA Priority Review Voucher Program Act . 2. Priority review to encourage treatments for tropical diseases Section 524 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360n ) is amended— (1) in subsection (a)(3)— (A) by redesignating subparagraph (Q) as subparagraph (R); (B) by inserting after subparagraph (P) the following: (Q) Filoviruses. ; and (C) in subparagraph (R), as so redesignated, by striking regulation by and inserting order of ; and (2) in subsection (b)— (A) in paragraph (2), by adding There is no limit on the number of times a priority review voucher may be transferred before such voucher is used. after the period at the end; and (B) in paragraph (4), by striking 365 days and inserting 90 days .