Sec. 3014. GAO STUDY OF PRIORITY REVIEW VOUCHER PROGRAMS
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## SEC. 3014 GAO STUDY OF PRIORITY REVIEW VOUCHER PROGRAMS ###
(a)Study The Comptroller General of the United States (referred to in this section as the “Comptroller General”) shall conduct a study addressing the effectiveness and overall impact of the following priority review voucher programs, including any such programs amended or established by this Act: ####
(1)The neglected tropical disease priority review voucher program under section 524 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360n). ####
(2)The rare pediatric disease priority review voucher program under section 529 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ff). ####
(3)The medical countermeasure priority review voucher program under section 565A of the Federal Food, Drug, and Cosmetic Act, as added by section 3086. ###
(b)Issuance of Report Not later than January 31, 2020, the Comptroller General shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report containing the results of the study under subsection (a). ###
(c)Contents of Reports The report submitted under subsection
(b)shall address— ####
(1)for each drug for which a priority review voucher has been awarded as of initiation of the study— #####
(A)the indications for which the drug is approved under section 505(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(c)), pursuant to an application under section 505(b)(1) of such Act, or licensed under section 351(a) of the Public Health Service Act (42 U.S.C. 262(a)); #####
(B)whether, and to what extent, the voucher impacted the sponsor’s decision to develop the drug; and #####
(C)whether, and to what extent, the approval or licensure of the drug, as applicable and appropriate— ######
(i)addressed a global unmet need related to the treatment or prevention of a neglected tropical disease, including whether the sponsor of a drug coordinated with international development organizations; ######
(ii)addressed an unmet need related to the treatment of a rare pediatric disease; or ######
(iii)affected the Nation’s preparedness against a chemical, biological, radiological, or nuclear threat, including naturally occurring threats; ####
(2)for each drug for which a priority review voucher has been used— #####
(A)the indications for which such drug is approved under section 505(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(c)), pursuant to an application under section 505(b)(1) of such Act, or licensed under section 351(a) of the Public Health Service Act (42 U.S.C. 262); #####
(B)the value of the voucher, if transferred; and #####
(C)the length of time between the date on which the voucher was awarded and the date on which the voucher was used; and ####
(3)an analysis of the priority review voucher programs described in subsection (a), including— #####
(A)the resources used by the Food and Drug Administration in reviewing drugs for which vouchers were used, including the effect of the programs on the Food and Drug Administration’s review of drugs for which priority review vouchers were not awarded or used; #####
(B)whether any improvements to such programs are necessary to appropriately target incentives for the development of drugs that would likely not otherwise be developed, or developed in as timely a manner, and, as applicable and appropriate— ######
(i)address global unmet needs related to the treatment or prevention of neglected tropical diseases, including in countries in which neglected tropical diseases are endemic; or ######
(ii)address unmet needs related to the treatment of rare pediatric diseases; and #####
(C)whether the sunset of the rare pediatric disease program and medical countermeasure program has had an impact on the program, including any potential unintended consequences. ###
(d)Protection of National Security The Comptroller General shall conduct the study and issue reports under this section in a manner that does not compromise national security.
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Sec. 3014
GAO STUDY OF PRIORITY REVIEW VOUCHER PROGRAMS
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