S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act

S. 2512: amends the Federal Food, Drug, and Cosmetic Act to add Zika virus disease to the list of tropical diseases under the priority review voucher program, which awards a voucher to the sponsor of a new drug or biological product that is approved to prevent or treat a tropical disease. (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.)

Cosponsors

11 cosponsors (7D, 4R)
Brown, Sherrod [D-OH] (joined Feb 8, 2016)
Nelson, Bill [D-FL] (joined Feb 8, 2016)
Kirk, Mark [R-IL] (joined Feb 10, 2016)
Casey, Robert “Bob” [D-PA] (joined Feb 24, 2016)
Portman, Robert “Rob” [R-OH] (joined Feb 24, 2016)
Klobuchar, Amy [D-MN] (joined Mar 10, 2016)
Murphy, Christopher [D-CT] (joined Mar 10, 2016)
Murray, Patty [D-WA] (joined Mar 10, 2016)
Alexander, Lamar [R-TN] (joined Mar 15, 2016)

Committee Assignments

 

History

FEB 8, 2016
Introduced

This is the first step in the legislative process.

Introduced

This is the first step in the legislative process.

MAR 9, 2016
Reported by Committee

A committee has issued a report to the full chamber recommending that the bill be considered further. Only about 1 in 4 bills are reported out of committee.

MAR 17, 2016
Passed Senate

The bill was passed in a vote in the Senate. It goes to the House next. The vote was by Unanimous Consent so no record of individual votes was made.

APR 12, 2016
Passed House

The bill was passed by both chambers in identical form. It goes to the President next who may sign or veto the bill. The vote was by voice vote so no record of individual votes was made.

APR 19, 2016
Enacted — Signed by the President

The President signed the bill and it became law.

Section 1102 of FDAAA, “Priority Review to Encourage Treatments for Tropical Diseases,” created the Neglected Tropical Disease Priority Review Voucher system.

As explained in the law and subsequent guidance documents, any new drug intended to treat the following list of tropical diseases is eligible to receive a transferrable voucher for priority review:

Eligible Diseases Under the Tropical Disease Priority Review Voucher System
Malaria Blinding trachoma
Buruli Ulcer Cholera
Dengue/Dengue haemorrhagic fever Dracunculiasis (guinea-worm disease)
Fascioliasis Human African trypanosomiasis
Leishmaniasis Leprosy
Lymphatic filariasis Onchocerciasis
Schistosomiasis Soil transmitted helminthiasis
Yaws Tuberculosis
Added by Congress
Cueva virus Ebola virus
Marburg virus Zika virus
Added by FDA Order
Chagas Neurocysticercosis

FDAAA also gave FDA the regulatory authority to add “any other infectious disease for which there is no significant market in developed nations and that disproportionately affects poor and marginalized populations.”

 

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