Adding Zika Virus to the FDA Priority Review Voucher Program Act

Bill: 114-s-2512
Sponsor: full_name: Sen. Franken, Al [D-MN]
Introduced: 2016-02-08
Policy area: Health
Subjects: Drug safety, medical device, and laboratory regulation

Drug therapy

Infectious and parasitic diseases
Latest action: action_date: 2016-04-19
text: Became Public Law No: 114-146.

Summaries:
action_date: 2016-02-08
action_desc: Introduced in Senate
text: <p><b>Adding Zika Virus to the FDA Priority Review Voucher Program Act</b></p> This bill amends the Federal Food, Drug, and Cosmetic Act to add the Zika virus 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.)

action_date: 2016-03-15
action_desc: Reported to Senate with amendment(s)
text: <p><b>Adding Zika Virus to the FDA Priority Review Voucher Program Act</b></p> <p>(Sec. 2) This bill 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.)</p> <p>The bill makes a technical correction to the tropical disease list to refer to filovirus disease, a condition caused by the family of viruses that includes the Ebola virus, instead of the family of viruses.</p>

action_date: 2016-03-17
action_desc: Passed Senate amended
text: <p>(This measure has not been amended since it was reported to the Senate on March 15, 2016. The summary of that version is repeated here.)</p> <p><b>Adding Zika Virus to the FDA Priority Review Voucher Program Act</b></p> <p>(Sec. 2) This bill 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.)</p> <p>The bill makes a technical correction to the tropical disease list to refer to filovirus disease, a condition caused by the family of viruses that includes the Ebola virus, instead of the family of viruses.</p>

action_date: 2016-04-12
action_desc: Passed House without amendment
text: <p>(This measure has not been amended since it was reported to the Senate on March 15, 2016. The summary of that version is repeated here.)</p> <p><b>Adding Zika Virus to the FDA Priority Review Voucher Program Act</b></p> <p>(Sec. 2) This bill 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.)</p> <p>The bill makes a technical correction to the tropical disease list to refer to filovirus disease, a condition caused by the family of viruses that includes the Ebola virus, instead of the family of viruses.</p>

action_date: 2016-04-19
action_desc: Public Law
text: <p>(This measure has not been amended since it was reported to the Senate on March 15, 2016. The summary of that version is repeated here.)</p> <p><b>Adding Zika Virus to the FDA Priority Review Voucher Program Act</b></p> <p>(Sec. 2) This bill 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.)</p> <p>The bill makes a technical correction to the tropical disease list to refer to filovirus disease, a condition caused by the family of viruses that includes the Ebola virus, instead of the family of viruses.</p>

tv_txt: II 114th CONGRESS 2d Session S. 2512 IN THE SENATE OF THE UNITED STATES February 8, 2016 Mr. Franken (for himself, Mr. Nelson , Mr. Isakson , and Mr. Brown ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To expand the tropical disease product priority review voucher program to encourage treatments for Zika virus.

1. Short title This Act may be cited as the Adding Zika Virus to the FDA Priority Review Voucher Program Act . 2. Expanding tropical disease product priority review voucher program to encourage treatments for Zika virus Section 524(a)(3) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360n ) is amended— (1) by redesignating subparagraph (R) as subparagraph (S); and (2) by inserting after subparagraph (Q) the following: (R) Zika virus. .

tv_txt: 114th CONGRESS 2d Session S. 2512 IN THE SENATE OF THE UNITED STATES AN ACT To expand the tropical disease product priority review voucher program to encourage treatments for Zika virus.

1. Short title This Act may be cited as the Adding Zika Virus to the FDA Priority Review Voucher Program Act . 2. Expanding tropical disease product priority review voucher program to encourage treatments for Zika Virus Disease 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 (R) as subparagraph (S); (2) in subparagraph (Q), by striking Filoviruses and inserting Filovirus Diseases ; and (3) by inserting after subparagraph (Q) the following: (R) Zika Virus Disease. .

Passed the Senate March 17, 2016. Secretary

tv_txt: IC 114th CONGRESS 2d Session S. 2512 IN THE HOUSE OF REPRESENTATIVES March 21, 2016 Referred to the Committee on Energy and Commerce AN ACT To expand the tropical disease product priority review voucher program to encourage treatments for Zika virus.

1. Short title This Act may be cited as the Adding Zika Virus to the FDA Priority Review Voucher Program Act . 2. Expanding tropical disease product priority review voucher program to encourage treatments for Zika Virus Disease 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 (R) as subparagraph (S); (2) in subparagraph (Q), by striking Filoviruses and inserting Filovirus Diseases ; and (3) by inserting after subparagraph (Q) the following: (R) Zika Virus Disease. .

Passed the Senate March 17, 2016. Julie E. Adams, Secretary

tv_txt: II Calendar No. 389 114th CONGRESS 2d Session S. 2512 IN THE SENATE OF THE UNITED STATES February 8, 2016 Mr. Franken (for himself, Mr. Nelson , Mr. Isakson , Mr. Brown , Mr. Menendez , Mr. Kirk , Mr. Casey , Mr. Portman , Mr. Murphy , Ms. Klobuchar , Mrs. Murray , and Mr. Alexander ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions March 15, 2016 Reported by Mr. Alexander , with an amendment Strike out all after the enacting clause and insert the part printed in italic A BILL To expand the tropical disease product priority review voucher program to encourage treatments for Zika virus.

1. Short title This Act may be cited as the Adding Zika Virus to the FDA Priority Review Voucher Program Act . 2. Expanding tropical disease product priority review voucher program to encourage treatments for Zika virus Section 524(a)(3) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360n ) is amended— (1) by redesignating subparagraph (R) as subparagraph (S); and (2) by inserting after subparagraph (Q) the following: (R) Zika virus. .

1. Short title This Act may be cited as the Adding Zika Virus to the FDA Priority Review Voucher Program Act . 2. Expanding tropical disease product priority review voucher program to encourage treatments for Zika Virus Disease 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 (R) as subparagraph (S); (2) in subparagraph (Q), by striking Filoviruses and inserting Filovirus Diseases ; and (3) by inserting after subparagraph (Q) the following: (R) Zika Virus Disease. .

March 15, 2016 Reported with an amendment

tv_txt: One Hundred Fourteenth Congress of the United States of America 2d Session Begun and held at the City of Washington on Monday, the fourth day of January, two thousand and sixteen S. 2512 IN THE SENATE OF THE UNITED STATES AN ACT To expand the tropical disease product priority review voucher program to encourage treatments for Zika virus.

1. Short title This Act may be cited as the Adding Zika Virus to the FDA Priority Review Voucher Program Act . 2. Expanding tropical disease product priority review voucher program to encourage treatments for Zika Virus Disease 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 (R) as subparagraph (S); (2) in subparagraph (Q), by striking Filoviruses and inserting Filovirus Diseases ; and (3) by inserting after subparagraph (Q) the following: (R) Zika Virus Disease. .

Speaker of the House of Representatives Vice President of the United States and President of the Senate