254 
lic Health Service Act for which the sponsor of 
the application used a priority review voucher 
under this section. 
‘‘(2) REPORT.—If, after the last day of the 1- 
year period that begins on the date that the Sec-
retary awards the third rare pediatric disease pri-
ority voucher under this section, a sponsor of an ap-
plication submitted under section 505(b) of this Act 
or section 351(a) of the Public Health Service Act 
for a drug uses a priority review voucher under this 
section for such application, the Secretary shall sub-
mit to the Committee on Energy and Commerce of 
the House of Representatives and the Committee on 
Health, Education, Labor, and Pensions of the Sen-
ate a document— 
‘‘(A) notifying such Committees of the use 
of such voucher; and 
‘‘(B) identifying the drug for which such 
priority review voucher is used. 
‘‘(g) ELIGIBILITY FOR OTHER PROGRAMS.—Nothing 
in this section precludes a sponsor who seeks a priority 
review voucher under this section from participating in 
any other incentive program, including under this Act. 
‘‘(h) RELATION TO OTHER PROVISIONS.—The provi-
sions of this section shall supplement, not supplant, any 
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other provisions of this Act or the Public Health Service 
Act that encourage the development of drugs for tropical 
diseases and rare pediatric diseases. 
‘‘(i) GAO STUDY AND REPORT.— 
‘‘(1) STUDY.— 
‘‘(A) IN GENERAL.—Beginning on the date 
that the Secretary awards the third rare pedi-
atric disease priority voucher under this section, 
the Comptroller General of the United States 
shall conduct a study of the effectiveness of 
awarding rare pediatric disease priority vouch-
ers under this section in the development of on 
human drug products that treat or prevent such 
diseases. 
‘‘(B) CONTENTS
OF
STUDY.—In con-
ducting the study under subparagraph (A), the 
Comptroller General shall examine the fol-
lowing: 
‘‘(i) The indications for which each 
rare disease product for which a priority 
review voucher was awarded was approved 
under section 505 or section 351 of the 
Public Health Service Act. 
‘‘(ii) Whether, and to what extent, an 
unmet need related to the treatment or 
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prevention of a rare pediatric disease was 
met through the approval of such a rare 
disease product. 
‘‘(iii) The value of the priority review 
voucher if transferred. 
‘‘(iv) Identification of each drug for 
which a priority review voucher was used. 
‘‘(v) The length of the period of time 
between the date on which a priority re-
view voucher was awarded and the date on 
which it was used. 
‘‘(2) REPORT.—Not later than 1 year after the 
date under paragraph (1)(A), the Comptroller Gen-
eral shall submit to the Committee on Energy and 
Commerce of the House of Representatives and the 
Committee on Health, Education, Labor, and Pen-
sions of the Senate, a report containing the results 
of the study under paragraph (1).’’. 
SEC. 866. COMBATING PRESCRIPTION DRUG ABUSE. 
(a) IN GENERAL.—To combat the significant rise in 
prescription drug abuse and the consequences of such 
abuse, the Secretary of Health and Human Services (re-
ferred to in this section as the ‘‘Secretary’’), acting 
through the Commissioner of Food and Drugs (referred 
to in this section as the ‘‘Commissioner’’) and in coordina-
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tion with other Federal agencies, as appropriate, shall re-
view current Federal initiatives and identify gaps and op-
portunities with respect to ensuring the safe use of pre-
scription drugs with the potential for abuse. 
(b) REPORT.—Not later than 1 year after the date 
of enactment of this Act, the Secretary shall issue a report 
to Congress on the findings of the review under subsection 
(a). Such report shall include recommendations on— 
(1) how best to leverage and build upon existing 
Federal and federally funded data sources, such as 
prescription drug monitoring program data and the 
sentinel initiative of the Food and Drug Administra-
tion under section 505(k)(3) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351(k)(3)), as 
it relates to collection of information relevant to ad-
verse events, patient safety, and patient outcomes, to 
create a centralized data clearinghouse and early 
warning tool; 
(2) how best to develop and disseminate widely 
best practices models and suggested standard re-
quirements to States for achieving greater interoper-
ability and effectiveness of prescription drug moni-
toring programs, especially with respect to producing 
standardized data on adverse events, patient safety, 
and patient outcomes; and 
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(3) how best to develop provider and patient 
education tools and a strategy to widely disseminate 
such tools and assess the efficacy of such tools. 
(c) GUIDANCE
ON
TAMPER-DETERRENT
PROD-
UCTS.—Not later than 6 months after the date of enact-
ment of this Act, the Secretary, acting through the Com-
missioner, shall promulgate guidance on the development 
of tamper-deterrent drug products. 
SEC. 867. ASSESSMENT AND MODIFICATION OF REMS. 
(a) ASSESSMENT AND MODIFICATION OF APPROVED 
STRATEGY.—Section 505–1(g) (21 U.S.C. 355–1(g)) is 
amended— 
(1) in paragraph (1), by striking ‘‘, and propose 
a modification to,’’; 
(2) in paragraph (2)— 
(A) in the matter before subparagraph 
(A)— 
(i) by striking ‘‘, subject to paragraph 
(5),’’; and 
(ii) by striking ‘‘, and may propose a 
modification to,’’; 
(B) in subparagraph (C), by striking ‘‘new 
safety or effectiveness information indicates 
that’’ and all that follows and inserting the fol-
lowing: ‘‘an assessment is needed to evaluate 
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