Adding Ebola to the FDA Priority Review Voucher Program Act

Bill: 113-s-2917
Sponsor: full_name: Sen. Harkin, Tom [D-IA]
Introduced: 2014-11-12
Policy area: Health
Subjects: Drug safety, medical device, and laboratory regulation

Drug therapy

Infectious and parasitic diseases
Latest action: action_date: 2014-12-16
text: Became Public Law No: 113-233.

Summaries:
action_date: 2014-11-12
action_desc: Introduced in Senate
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.

action_date: 2014-11-19
action_desc: Reported to Senate without amendment
text: <p><b>(This measure has not been amended since it was introduced. The summary has been expanded because action occurred on the measure.)</b></p> <p>Adding Ebola to the FDA Priority Review Voucher Program Act - (Sec. 2) 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.

action_date: 2014-12-02
action_desc: Passed Senate without amendment
text: <p><b>(This measure has not been amended since it was introduced. The expanded summary of the Senate reported version is repeated here.)</b></p> <p></p> <p>Adding Ebola to the FDA Priority Review Voucher Program Act - (Sec. 2) 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.

action_date: 2014-12-03
action_desc: Passed House without amendment
text: <p><b>(This measure has not been amended since it was introduced. The expanded summary of the Senate reported version is repeated here.)</b></p> <p></p> <p>Adding Ebola to the FDA Priority Review Voucher Program Act - (Sec. 2) 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.

action_date: 2014-12-16
action_desc: Public Law
text: <p><b>(This measure has not been amended since it was introduced. The expanded summary of the Senate reported version is repeated here.)</b></p> <p>Adding Ebola to the FDA Priority Review Voucher Program Act - (Sec. 2) 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: II Calendar No. 602 113th CONGRESS 2d Session S. 2917 IN THE SENATE OF THE UNITED STATES November 12, 2014 Mr. Harkin (for himself, Mr. Alexander , Ms. Mikulski , Mr. Enzi , Mrs. Murray , Mr. Burr , Mr. Casey , Mr. Isakson , Mrs. Hagan , Mr. Hatch , Mr. Franken , Mr. Roberts , Mr. Bennet , Mr. Kirk , Mr. Whitehouse , Mr. Scott , Ms. Baldwin , Mr. Murphy , Ms. Warren , Ms. Klobuchar , Mr. Blumenthal , Mr. Markey , Mr. Brown , Mr. Coburn , Ms. Collins , Mr. Durbin , Mr. Kaine , Mr. Blunt , Ms. Ayotte , Mrs. Boxer , Mr. Vitter , Mr. Cornyn , Mr. McConnell , Mr. Coons , Mr. Schumer , Mr. Moran , Mr. Portman , Mr. Booker , Mrs. Feinstein , Ms. Murkowski , Mr. Chambliss , Mr. Warner , Mrs. Gillibrand , Ms. Stabenow , Mr. Heinrich , and Mrs. Shaheen ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions November 19, 2014 Reported by Mr. Harkin , without amendment 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 .

November 19, 2014 Reported without amendment

tv_txt: II 113th CONGRESS 2d Session S. 2917 IN THE SENATE OF THE UNITED STATES November 12, 2014 Mr. Harkin (for himself, Mr. Alexander , Ms. Mikulski , Mr. Enzi , Mrs. Murray , Mr. Burr , Mr. Casey , Mr. Isakson , Mrs. Hagan , Mr. Hatch , Mr. Franken , Mr. Roberts , Mr. Bennet , Mr. Kirk , Mr. Whitehouse , Mr. Scott , Ms. Baldwin , Mr. Murphy , Ms. Warren , Ms. Klobuchar , Mr. Blumenthal , Mr. Markey , Mr. Brown , Mr. Coburn , Ms. Collins , and Mr. Durbin ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 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 .

tv_txt: One Hundred Thirteenth Congress of the United States of America 2d Session Begun and held at the City of Washington on Friday, the third day of January, two thousand and fourteen S. 2917 IN THE SENATE OF THE UNITED STATES AN ACT 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 .

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

tv_txt: 113th CONGRESS 2d Session S. 2917 IN THE SENATE OF THE UNITED STATES AN ACT 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 .

Passed the Senate December 2, 2014. Secretary