Adding Epidemic Diseases to the FDA Priority Review Voucher Program Act

Bill: 116-hr-4553
Sponsor: full_name: Rep. Boyle, Brendan F. [D-PA-2]
Introduced: 2019-09-27
Policy area: Health
Subjects: Cardiovascular and respiratory health

Drug safety, medical device, and laboratory regulation

Drug therapy

Infectious and parasitic diseases
Latest action: action_date: 2019-09-30
text: Referred to the Subcommittee on Health.

Summaries:
action_date: 2019-09-27
action_desc: Introduced in House
text: <p><b>Adding Epidemic Diseases to the FDA Priority Review Voucher Program Act</b></p> <p>This bill expands the priority-review voucher program for tropical diseases to include Middle East respiratory syndrome, Nipah virus, and Rift Valley fever. A voucher entitles the holder to have a future new drug or biological product application acted upon by the Food and Drug Administration within six months.</p>

tv_txt: I 116th CONGRESS 1st Session H. R. 4553 IN THE HOUSE OF REPRESENTATIVES September 27, 2019 Mr. Brendan F. Boyle of Pennsylvania (for himself, Mr. Marshall , Mr. Veasey , and Mr. Fortenberry ) introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To expand the tropical disease product priority review voucher program to encourage treatments for the Middle East respiratory syndrome, Nipah, and Rift Valley fever.

1. Short title This Act may be cited as the Adding Epidemic Diseases to the FDA Priority Review Voucher Program Act . 2. Expanding tropical disease product priority review voucher program to encourage treatments for Middle East respiratory syndrome, Nipah, and Rift Valley fever Section 524(a)(3) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360n(a)(3) ) is amended— (1) by redesignating subparagraph (S) as subparagraph (V); and (2) by inserting after subparagraph (R) the following: (S) Middle East respiratory syndrome. (T) Nipah. (U) Rift Valley fever. .