this subsection and the drug may not be 
dispensed without a prescription, the appli-
cant shall include a proposed risk evalua-
tion and mitigation strategy in an applica-
tion, including in a supplemental applica-
tion, seeking a new indication for such 
drug. 
‘‘(iii) CONTENTS.—A proposed risk 
evaluation and mitigation strategy— 
‘‘(I) shall include the minimal 
elements required under paragraph 
(3); and 
‘‘(II) may also include additional 
elements as provided for under para-
graphs (4) and (5). 
‘‘(B) ASSESSMENT AND MODIFICATION OF 
A RISK EVALUATION AND MITIGATION STRAT-
EGY.— 
‘‘(i) VOLUNTARY ASSESSMENTS.—The 
applicant may submit to the Secretary an 
assessment of, and propose a modification 
to, the approved risk evaluation and miti-
gation strategy for a drug at any time. 
‘‘(ii) REQUIRED ASSESSMENTS.—The 
applicant shall submit an assessment of, 
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and may propose a modification to, the ap-
proved risk evaluation and mitigation 
strategy for a drug— 
‘‘(I) when submitting a supple-
mental application for a new indica-
tion under subsection (b) or section 
351 of the Public Health Service Act, 
unless the drug may be dispensed 
without a prescription and the risk 
evaluation and mitigation strategy for 
the drug includes only the elements 
under paragraph (3); 
‘‘(II) when required by the strat-
egy, as provided for in the timetable 
under paragraph (3)(E); 
‘‘(III) within a time specified by 
the Secretary, not to be less than 45 
days, when ordered by the Secretary, 
if the Secretary determines that new 
safety or effectiveness information in-
dicates that an element under para-
graph (3) or (4) should be modified or 
included in the strategy; 
‘‘(IV) within 90 days when or-
dered by the Secretary, if the Sec-
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retary determines that new safety or 
effectiveness 
information 
indicates 
that an element under paragraph (5) 
should be modified or included in the 
strategy; or 
‘‘(V) within 15 days when or-
dered by the Secretary, if the Sec-
retary determines that there may be a 
cause for action by the Secretary 
under subsection (e). 
‘‘(iii) ASSESSMENT.—An assessment 
of the approved risk evaluation and mitiga-
tion strategy for a drug shall include— 
‘‘(I) with respect to any goal 
under paragraph (5), an assessment 
of how well the restrictions on dis-
tribution or use are meeting the goal 
or whether the goal or such restric-
tions should be modified; 
‘‘(II) with respect to any post-ap-
proval study required under para-
graph (4)(D), the status of such 
study, including whether any difficul-
ties completing the study have been 
encountered; and 
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‘‘(III) with respect to any post- 
approval clinical trial required under 
paragraph (4)(E), the status of such 
clinical trial, including whether enroll-
ment has begun, the number of par-
ticipants enrolled, the expected com-
pletion date, whether any difficulties 
completing the clinical trial have been 
encountered, and registration informa-
tion with respect to requirements 
under section 402(i) of the Public 
Health Service Act. 
‘‘(iv) MODIFICATION.—A modification 
(whether an enhancement or a reduction) 
to the approved risk evaluation and mitiga-
tion strategy for a drug may include the 
addition or modification of any element 
under subparagraph (A), (C), or (D) of 
paragraph (3) or the addition, modifica-
tion, or removal of any element under 
paragraph (4) or (5), such as— 
‘‘(I) a labeling change, including 
the addition of a boxed warning; 
‘‘(II) 
adding 
a 
post-approval 
study or clinical trial requirement; 
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‘‘(III) modifying a post-approval 
study or clinical trial requirement 
(such as a change in trial design due 
to legitimate difficulties recruiting 
participants); 
‘‘(IV) adding, modifying, or re-
moving a restriction on advertising 
under subparagraph (F), (G), and 
(H) of paragraph (4); 
‘‘(V) adding, modifying, or re-
moving a restriction on distribution or 
use under paragraph (5); or 
‘‘(VI) modifying the timetable for 
assessments of the strategy under 
paragraph (3)(E), including to elimi-
nate assessments. 
‘‘(C) REVIEW.— 
‘‘(i) IN
GENERAL.—The Secretary 
shall promptly review the proposed risk 
evaluation and mitigation strategy for a 
drug submitted under subparagraph (A), 
or an assessment of the approved risk eval-
uation and mitigation strategy for a drug 
submitted under subparagraph (B). 
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‘‘(ii) MARKETING PLAN.—As part of a 
review conducted under this subparagraph, 
the Secretary may require the applicant to 
submit its marketing plan for the drug, so 
as to allow the Secretary to determine 
whether any of the proposed or ongoing 
marketing activities undermine any of the 
requirements of the risk evaluation and 
mitigation strategy. 
‘‘(D) DISCUSSION.—The Secretary shall 
initiate discussions of the proposed risk evalua-
tion and mitigation strategy for a drug sub-
mitted under subparagraph (A), or of an as-
sessment of the approved risk evaluation and 
mitigation strategy for a drug submitted under 
subparagraph (B), with the applicant to deter-
mine a strategy— 
‘‘(i) if the proposed strategy or assess-
ment is submitted as part of an application 
or supplemental application under subpara-
graph (A) or (B)(ii)(I), not less than 60 
days before the action deadline for the ap-
plication that has been agreed to by the 
Secretary and that has been set forth in 
goals identified in letters of the Secretary 
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(relating to the use of fees collected under 
section 736 to expedite the drug develop-
ment process and the review of human 
drug applications); 
‘‘(ii) if the assessment is submitted 
under subclause (II) or (III) of subpara-
graph (B)(ii), not later than 20 days after 
such submission; 
‘‘(iii) if the assessment is submitted 
under subparagraph (B)(i) or under sub-
paragraph (B)(ii)(IV), not later than 30 
days after such submission; or 
‘‘(iv) if the assessment is submitted 
under subparagraph (B)(ii)(V), not later 
than 10 days after such submission. 
‘‘(E) ACTION.— 
‘‘(i) IN GENERAL.—Unless the appli-
cant requests the dispute resolution proc-
ess described under subparagraph (F), the 
Secretary shall approve and describe the 
risk evaluation and mitigation strategy for 
a drug, or any modification to the strat-
egy— 
‘‘(I) as part of the action letter 
on the application, when a proposed 
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strategy is submitted under subpara-
graph (A) or an assessment of the 
strategy is submitted under subpara-
graph (B)(ii)(I); or 
‘‘(II) in an order issued not later 
than 50 days after the date discus-
sions of such modification begin under 
subparagraph (C), when an assess-
ment of the strategy is under sub-
paragraph (B)(i) or under subclause 
(II), (III), (IV), or (V) of subpara-
graph (B)(ii). 
‘‘(ii) INACTION.—An approved risk 
evaluation and mitigation strategy shall re-
main in effect until the Secretary acts, if 
the Secretary fails to act as provided under 
clause (i). 
‘‘(iii) PUBLIC AVAILABILITY.—Any ac-
tion letter described in clause (i)(I) or 
order described in clause (i)(II) shall be 
made publicly available. 
‘‘(F) DISPUTE RESOLUTION.— 
‘‘(i) REQUEST
FOR
REVIEW.—Not 
earlier than 15 days, and not later than 35 
days, after discussions under subparagraph 
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(D) have begun, the applicant may request 
in writing that a dispute about the strat-
egy be reviewed by the Drug Safety Over-
sight Board. Upon receipt of such a re-
quest, the Secretary shall schedule the dis-
pute for review under clause (ii) and, not 
later than 5 business days of scheduling 
the dispute for review, shall publish by 
posting on the Internet or otherwise a no-
tice that the dispute will be reviewed by 
the Drug Safety Oversight Board. 
‘‘(ii) SCHEDULING
REVIEW.—If the 
applicant requests review under clause (i), 
the Secretary— 
‘‘(I) shall schedule the dispute 
for review at 1 of the next 2 regular 
meetings of the Drug Safety Over-
sight Board, whichever meeting date 
is more practicable; or 
‘‘(II) may convene a special 
meeting of the Drug Safety Oversight 
Board to review the matter more 
promptly, including to meet an action 
deadline on an application (including 
a supplemental application). 
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‘‘(iii) AGREEMENT AFTER DISCUSSION 
OR ADMINISTRATIVE APPEALS.— 
‘‘(I) FURTHER
DISCUSSION
OR 
ADMINISTRATIVE
APPEALS.—A 
re-
quest for review under clause (i) shall 
not preclude further discussions to 
reach agreement on the risk evalua-
tion and mitigation strategy, and such 
a request shall not preclude the use of 
administrative 
appeals 
within 
the 
Food and Drug Administration to 
reach agreement on the strategy, in-
cluding appeals as described in letters 
of the Secretary (relating to the use of 
fees collected under section 736 to ex-
pedite the drug development process 
and the review of human drug appli-
cations) for procedural or scientific 
matters involving the review of human 
drug applications and supplemental 
applications that cannot be resolved at 
the divisional level. 
‘‘(II) AGREEMENT
TERMINATES 
DISPUTE RESOLUTION.—At any time 
before a decision and order is issued 
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under clause (vii), the Secretary and 
the applicant may reach an agreement 
on the risk evaluation and mitigation 
strategy through further discussion or 
administrative appeals, terminating 
the dispute resolution process, and the 
Secretary shall issue an action letter 
or order, as appropriate, that de-
scribes the strategy. 
‘‘(iv) MEETING OF THE BOARD.—At 
the meeting of the Drug Safety Oversight 
Board described in clause (ii), the Board 
shall— 
‘‘(I) hear from both parties; and 
‘‘(II) review the dispute. 
‘‘(v) RECORD OF PROCEEDINGS.—The 
Secretary shall ensure that the proceedings 
of any such meeting are recorded, tran-
scribed, and made public within 30 days of 
the meeting. The Secretary shall redact the 
transcript to protect any trade secrets or 
other confidential information described in 
section 552(b)(4) of title 5, United States 
Code. 
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‘‘(vi) 
RECOMMENDATION
OF
THE 
BOARD.—Not later than 5 days after any 
such meeting, the Drug Safety Oversight 
Board shall provide a written recommenda-
tion on resolving the dispute to the Sec-
retary. Not later than 5 days after the 
Board provides such written recommenda-
tion to the Secretary, the Secretary shall 
make the recommendation available to the 
public. 
‘‘(vii) ACTION BY THE SECRETARY.— 
‘‘(I) ACTION LETTER.—With re-
spect to a proposed risk evaluation 
and mitigation strategy submitted 
under subparagraph (A) or to an as-
sessment of the strategy submitted 
under subparagraph (B)(ii)(I), the 
Secretary shall issue an action letter 
that resolves the dispute not later 
than the later of— 
‘‘(aa) the action deadline re-
ferred to in subparagraph (D)(i); 
or 
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‘‘(bb) 7 days after receiving 
the recommendation of the Drug 
Safety Oversight Board. 
‘‘(II) ORDER.—With respect to 
an assessment of the risk evaluation 
and mitigation strategy under sub-
paragraph (B)(i) or under subclause 
(II), (III), (IV), or (V) of subpara-
graph (B)(ii), the Secretary shall 
issue an order, which shall be made 
public, that resolves the dispute not 
later than 7 days after receiving the 
recommendation of the Drug Safety 
Oversight Board. 
‘‘(viii) INACTION.—An approved risk 
evaluation and mitigation strategy shall re-
main in effect until the Secretary acts, if 
the Secretary fails to act as provided for 
under clause (vii). 
‘‘(ix) EFFECT
ON
ACTION
DEAD-
LINE.—With respect to the application or 
supplemental application in which a pro-
posed risk evaluation and mitigation strat-
egy is submitted under subparagraph (A) 
or in which an assessment of the strategy 
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is 
submitted 
under 
subparagraph 
(B)(ii)(I), the Secretary shall be considered 
to have met the action deadline referred to 
in subparagraph (D)(i) with respect to 
such application if the applicant requests 
the dispute resolution process described in 
this subparagraph and if the Secretary— 
‘‘(I) has initiated the discussions 
described under subparagraph (D) not 
less than 60 days before such action 
deadline; and 
‘‘(II) has complied with the tim-
ing requirements of scheduling review 
by the Drug Safety Oversight Board, 
providing a written recommendation, 
and issuing an action letter under 
clauses (ii), (vi), and (vii), respec-
tively. 
‘‘(x) DISQUALIFICATION.—No indi-
vidual who is an employee of the Food and 
Drug Administration and who reviews a 
drug or who participated in an administra-
tive appeal under clause (iii)(I) with re-
spect to such drug may serve on the Drug 
Safety Oversight Board at a meeting under 
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clause (iv) to review a dispute about the 
risk evaluation and mitigation strategy for 
such drug. 
‘‘(xi) ADDITIONAL
EXPERTISE.—The 
Drug Safety Oversight Board may add 
members with relevant expertise from the 
Food and Drug Administration, including 
the Office of Pediatrics, the Office of 
Women’s Health, or the Office of Rare 
Diseases, or from other Federal public 
health or health care agencies, for a meet-
ing under clause (iv) of the Drug Safety 
Oversight Board. 
‘‘(G) USE
OF
ADVISORY
COMMITTEES.— 
The Secretary may convene a meeting of 1 or 
more advisory committees of the Food and 
Drug Administration to— 
‘‘(i) review a concern about the safety 
of a drug or class of drugs, including be-
fore an assessment of the risk evaluation 
and mitigation strategy or strategies of 
such drug or drugs is required to be sub-
mitted under subclause (II), (III), (IV), or 
(V) of subparagraph (B)(ii); 
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‘‘(ii) review the risk evaluation and 
mitigation strategy or strategies of a drug 
or group of drugs; or 
‘‘(iii) review a dispute under subpara-
graph (F). 
‘‘(H) PROCESS
FOR
ADDRESSING
DRUG 
CLASS EFFECTS.— 
‘‘(i) IN GENERAL.—When a concern 
about a serious risk of a drug may be re-
lated to the pharmacological class of the 
drug, the Secretary may defer assessments 
of the approved risk evaluation and mitiga-
tion strategies for such drugs until the 
Secretary has convened 1 or more public 
meetings to consider possible responses to 
such concern. If the Secretary defers an 
assessment under this clause, the Sec-
retary shall give notice to the public of the 
deferral not later than 5 days of the defer-
ral. 
‘‘(ii) PUBLIC MEETINGS.—Such public 
meetings may include— 
‘‘(I) 1 or more meetings of the 
applicants for such drugs; 
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‘‘(II) 1 or more meetings of 1 or 
more advisory committees of the Food 
and Drug Administration, as provided 
for under subparagraph (G); or 
‘‘(III) 1 or more workshops of 
scientific experts and other stake-
holders. 
‘‘(iii) ACTION.—After considering the 
discussions from any meetings under 
clause (ii), the Secretary may— 
‘‘(I) announce in the Federal 
Register a planned regulatory action, 
including a modification to each risk 
evaluation and mitigation strategy, for 
drugs in the pharmacological class; 
‘‘(II) seek public comment about 
such action; and 
‘‘(III) after seeking such com-
ment, issue an order addressing such 
regulatory action. 
‘‘(I) 
INTERNATIONAL
COORDINATION.— 
The Secretary may coordinate the timetable for 
submission of assessments under paragraph 
(3)(E), a study under paragraph (4)(D), or a 
clinical trial under paragraph (4)(E), with ef-
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forts to identify and assess the serious risks of 
such drug by the marketing authorities of other 
countries whose drug approval and risk man-
agement processes the Secretary deems com-
parable to the drug approval and risk manage-
ment processes of the United States. If the Sec-
retary takes action to coordinate such time-
table, the Secretary shall give notice to the pub-
lic of the action not later than 5 days after the 
action. 
‘‘(J) EFFECT.—Use of the processes de-
scribed in subparagraphs (H) and (I) shall not 
delay action on an application or a supplement 
to an application for a drug. 
‘‘(K) NO EFFECT ON LABELING CHANGES 
THAT DO NOT REQUIRE PREAPPROVAL.—In the 
case of a labeling change to which section 
314.70 of title 21, Code of Federal Regulations 
(or any successor regulation), applies for which 
the submission of a supplemental application is 
not required or for which distribution of the 
drug involved may commence upon the receipt 
by the Secretary of a supplemental application 
for the change, the submission of an assessment 
of the approved risk evaluation and mitigation 
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strategy for the drug under this subsection is 
not required. 
‘‘(7) DRUG SAFETY OVERSIGHT BOARD.— 
‘‘(A) IN GENERAL.—There is established a 
Drug Safety Oversight Board. 
‘‘(B) 
COMPOSITION; 
MEETINGS.—The 
Drug Safety Oversight Board shall— 
‘‘(i) be composed of scientists and 
health care practitioners appointed by the 
Secretary, each of whom is an employee of 
the Federal Government; 
‘‘(ii) include representatives from of-
fices throughout the Food and Drug Ad-
ministration; 
‘‘(iii) include at least 1 representative 
from each of the National Institutes of 
Health, the Department of Health and 
Human Services (other than the Food and 
Drug Administration), and the Veterans 
Health Administration; and 
‘‘(iv) meet at least monthly to provide 
oversight and advice to the Secretary on 
the management of important drug safety 
issues.’’. 
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SEC. 102. ENFORCEMENT. 
(a) MISBRANDING.—Section 502 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amend-
ed by adding at the end the following: 
‘‘(y) If it is a drug subject to an approved risk evalua-
tion and mitigation strategy under section 505(o) and the 
applicant for such drug fails to— 
‘‘(1) make a labeling change required by such 
strategy after the Secretary has completed review of, 
and acted on, an assessment of such strategy under 
paragraph (6) of such section; or 
‘‘(2) comply with a requirement of such strat-
egy provided for under paragraph (3), (4), or (5) of 
such section. 
‘‘(z) Failure to conduct a postmarket study required 
under section 506 (or any regulation thereunder).’’. 
(b) CIVIL PENALTIES.—Section 303(f) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 333(f)) is 
amended— 
(1) by redesignating paragraphs (3), (4), and 
(5) as paragraphs (4), (5), and (6), respectively; 
(2) by inserting after paragraph (2) the fol-
lowing: 
‘‘(3) Any person who violates a requirement of this 
Act which relates to drugs shall be liable to the United 
States for a civil penalty in an amount not less than 
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$50,000 for each such violation and, for all such violations 
adjudicated in a single proceeding, in an amount not to 
exceed the following: 
‘‘(A) For drugs on the market for at least one year, 
10 percent of the annual United States sales revenue dur-
ing the year prior to which the person is subject to the 
civil penalty, based upon data from IMS Health Inc.’s Re-
tail and Provider Prospective Combined Purchases on the 
United States sales revenue of the drug or, in the event 
IMS data is not available, based upon any comparable 
data. 
‘‘(B) For drugs on the market for less than one year, 
$1,000,000.’’; 
(3) in paragraph (2)(C), by striking ‘‘paragraph 
(3)(A)’’ and inserting ‘‘paragraph (4)(A)’’; 
(4) in paragraph (4), as so redesignated, by 
striking ‘‘paragraph (1) or (2)’’ each place it ap-
pears and inserting ‘‘paragraph (1), (2), or (3)’’; 
and 
(5) in paragraph (6), as so redesignated, by 
striking ‘‘paragraph (4)’’ each place it appears and 
inserting ‘‘paragraph (5)’’. 
SEC. 103. REGULATION OF BIOLOGICAL PRODUCTS. 
Section 351 of the Public Health Service Act (42 
U.S.C. 262) is amended— 
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(1) in subsection (a)(2), by adding at the end 
the following: 
‘‘(D) RISK EVALUATION AND MITIGATION STRAT-
EGY.—A person that submits an application for a license 
under this paragraph shall submit to the Secretary as part 
of the application a proposed risk evaluation and mitiga-
tion strategy as described under section 505(o) of the Fed-
eral Food, Drug, and Cosmetic Act.’’; and 
(2) in subsection (j), by inserting ‘‘, including 
the requirements under section 505(o) of such Act,’’ 
after ‘‘, and Cosmetic Act’’. 
SEC. 104. NO EFFECT ON WITHDRAWAL OR SUSPENSION OF 
APPROVAL. 
Section 505(e) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355(e)) is amended by adding at 
the end the following: ‘‘The Secretary may withdraw the 
approval of an application submitted under this section, 
or suspend the approval of such an application, as pro-
vided under this subsection, without first ordering the ap-
plicant to submit an assessment of the approved risk eval-
uation and mitigation strategy for the drug under sub-
section (o)(6)(B)(ii)(V).’’. 
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SEC. 105. DRUGS SUBJECT TO AN ABBREVIATED NEW DRUG 
APPLICATION. 
Section 505(j)(2) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(j)(2)) is amended by adding 
at the end the following: 
‘‘(E) RISK EVALUATION AND MITIGATION STRATEGY 
REQUIREMENT.— 
‘‘(i) IN GENERAL.—A drug that is the subject 
of an abbreviated new drug application under this 
subsection shall be subject to only the following ele-
ments of the risk evaluation and mitigation strategy 
required under subsection (o) for the applicable list-
ed drug: 
‘‘(I) Labeling, as required under subsection 
(o)(3)(A) for the applicable listed drug. 
‘‘(II) Submission of reports, as required 
under subsection (o)(3)(B)(i) for the applicable 
listed drug. 
‘‘(III) A Medication Guide or patient pack-
age 
insert, 
if 
required 
under 
subsection 
(o)(4)(B) for the applicable listed drug. 
‘‘(IV) Preclearance of advertising, if re-
quired under subsection (o)(4)(F) for the appli-
cable listed drug. 
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‘‘(V) Specific disclosures in advertising, if 
required under subsection (o)(4)(G) for the ap-
plicable listed drug. 
‘‘(VI) A temporary moratorium on direct- 
to-consumer advertising, if required under sub-
section (o)(4)(H) for the applicable listed drug. 
‘‘(VII) Restrictions on distribution or use, 
if required under subsection (o)(5) for the listed 
drug. A drug that is the subject of an abbre-
viated new drug application and the listed drug 
shall use a single, shared system under sub-
section (o)(5)(D). The Secretary may waive the 
requirement under the preceding sentence for a 
drug that is the subject of an abbreviated new 
drug application if the Secretary determines 
that (aa) it is not practical for the drug to use 
such single, shared system or (bb) the burden 
of using the single, shared system outweighs 
the benefit of using the single system. 
‘‘(ii) ACTION BY SECRETARY.—For an applica-
ble listed drug for which a drug is approved under 
this subsection, the Secretary— 
‘‘(I) shall undertake any communication 
plan to health care providers required under 
section (o)(4)(C) for the applicable listed drug; 
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‘‘(II) shall conduct any post-approval study 
required under subsection (o)(4)(D) for the ap-
plicable listed drug; and 
‘‘(III) shall inform the applicant for a drug 
approved under this subsection if the risk eval-
uation and mitigation strategy for the applica-
ble listed drug is modified.’’. 
SEC. 106. CONFORMING AMENDMENTS. 
(a) PRECLEARANCE OF ADVERTISEMENTS.—Section 
502(n)(3)(A) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 352(n)(3)(A)) is amended by inserting 
‘‘(or when required under section 505(o)(4)(F))’’ after 
‘‘except in extraordinary circumstances’’. 
(b) CONTENT OF NEW DRUG APPLICATION.—Section 
505(b)(1) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355(b)) is amended— 
(1) in subparagraph (F), by striking ‘‘and’’; 
and 
(2) in subparagraph (G), by striking the period 
and inserting the following: ‘‘, and (H) a proposed 
risk evaluation and mitigation strategy as described 
under subsection (o).’’. 
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SEC. 107. RESOURCES. 
(a) USER
FEES.—Subparagraph (F) of section 
735(6) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 379g(6)) is amended to read as follows: 
‘‘(F) Reviewing and implementing risk 
evaluation and mitigation strategies, and col-
lecting, developing, and reviewing safety or ef-
fectiveness information on drugs, including ad-
verse event reports.’’. 
(b) WORKLOAD ADJUSTMENT.—Subparagraph (A) of 
section 736(c)(2) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 379h(c)(2)) is amended to read as 
follows: 
‘‘(A) The adjustment shall be determined 
by the Secretary based on a weighted average 
of the change in the total number of human 
drug applications; commercial investigational 
new drug applications; efficacy supplements; 
manufacturing supplements; implementation, 
assessment, review, and enforcement activities 
for risk evaluation and mitigation strategies; 
and uses of dispute resolution under the process 
for reviewing and assessing risk evaluation and 
mitigation strategies. The Secretary shall pub-
lish in the Federal Register the fee revenues 
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and fees resulting from the adjustment and 
supporting methodologies.’’. 
(c) STRATEGIC PLAN
FOR INFORMATION TECH-
NOLOGY.—Not later than 1 year after the date of enact-
ment of this title, the Secretary of Health and Human 
Services (referred to in this Act as the ‘‘Secretary’’) shall 
submit to the Committee on Health, Education, Labor, 
and Pensions and the Committee on Appropriations of the 
Senate and the Committee on Energy and Commerce and 
the Committee on Appropriations of the House of Rep-
resentatives, a strategic plan on information technology 
that includes— 
(1) an assessment of the information technology 
infrastructure, including systems for data collection, 
access to data in external health care databases (in-
cluding databases of the Centers for Medicare & 
Medicaid Services and the Department of Veterans 
Affairs), data mining capabilities, personnel, and 
personnel training programs, needed by the Food 
and Drug Administration to— 
(A) comply with the requirements of this 
title (and the amendments made by this title); 
(B) achieve interoperability within and 
among the Centers of the Food and Drug Ad-
ministration and between the Food and Drug 
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Administration and product application spon-
sors; and 
(C) utilize electronic health records; 
(2) an assessment of the extent to which the 
current information technology assets of the Food 
and Drug Administration are sufficient to meet the 
needs assessments under paragraph (1); 
(3) a plan for enhancing the information tech-
nology assets of the Food and Drug Administration 
toward meeting the needs assessments under para-
graph (1); and 
(4) an assessment of additional resources need-
ed to so enhance the information technology assets 
of the Food and Drug Administration. 
SEC. 108. DRUG LABELING. 
(a) ACCESSIBLE REPOSITORY
OF DRUG LABEL-
ING.—Not later than the effective date of this title, the 
Secretary, through the Commissioner of Food and Drugs, 
and the Director of the National Institutes of Health, shall 
establish a searchable repository of structured, electronic 
product information (including health warnings, Dear 
Doctor letters, and the approved professional labeling and 
any required patient labeling of each drug approved under 
section 505 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355) or licensed under section 351 of the Pub-
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lic Health Service Act (42 U.S.C. 262)) in order to im-
prove patient safety through accessible product informa-
tion, support initiatives to improve patient care by better 
management of health care information, and provide 
standards for drug information. Such repository shall be 
made publicly accessible on the Internet website of the Na-
tional Library of Medicine and through a link on the 
homepage of the Internet website of the Food and Drug 
Administration. 
(b) POSTING UPON APPROVAL.—The Secretary shall 
post in the repository under subsection (a) the approved 
professional labeling and any required patient labeling of 
a drug approved under such section 505 or licensed under 
such section 351 not later than 21 days after the date 
the drug is approved, including in a supplemental applica-
tion with respect to a labeling change. 
(c) REPORT.—The Secretary shall report annually to 
the Committee on Health, Education, Labor and Pensions 
of the Senate and the Committee on Energy and Com-
merce of the House of Representatives on the status of 
the repository under subsection (a), and on progress in 
posting structured electronic product information, includ-
ing posting of information regarding drugs approved prior 
to the effective date of this title. 
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(d) MEDICATION GUIDES.—Not later than the effec-
tive date of this title, the Secretary, through the Commis-
sioner of Food and Drugs, shall establish on the Internet 
website for the repository under subsection (a), a link to 
a list of each drug, whether approved under such section 
505 or licensed under such section 351, for which a Medi-
cation Guide, as provided for under part 208 of title 21, 
Code of Federal Regulations (or any successor regula-
tions), is required. 
SEC. 109. FACTORY INSPECTIONS. 
Paragraph (1) of section 704(a) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 374(a)) is amended 
by inserting ‘‘or marketing data’’ after ‘‘No inspection au-
thorized by the preceding sentence or by paragraph (3) 
shall extend to financial data, sales data other than ship-
ment data’’. 
SEC. 110. STUDY ON INTEGRATION OF EXPERTISE OF OF-
FICE 
OF 
SURVEILLANCE 
AND 
EPIDEMI-
OLOGY. 
Not later than 1 year after the date of the enactment 
of this Act, the Commissioner of Food and Drugs shall 
submit a report to the Congress on the Commissioner’s 
efforts to integrate the expertise of the Office of Surveil-
lance and Epidemiology into the Food and Drug Adminis-
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tration’s approval, labeling, and post-approval safety deci-
sions. 
SEC. 111. BENEFIT-RISK ASSESSMENTS. 
Not later than 1 year after the date of the enactment 
of this Act, the Commissioner of Food and Drugs shall 
submit to the Congress a report on how best to commu-
nicate to the public the risks and benefits of new drugs 
and the role of the risk evaluation and mitigation strategy 
in assessing such risks and benefits. 
SEC. 112. EFFECTIVE DATE AND APPLICABILITY. 
(a) EFFECTIVE DATE.—This title shall take effect 
180 days after the date of enactment of this Act. 
(b) DRUGS DEEMED TO HAVE RISK EVALUATION 
AND MITIGATION STRATEGIES.— 
(1) IN GENERAL.—A drug that was approved 
before the effective date of this title shall be deemed 
to have an approved risk evaluation and mitigation 
strategy under section 505(o) of the Federal Food, 
Drug, and Cosmetic Act (as added by this title) if 
there are in effect on the effective date of this title 
restrictions on distribution or use— 
(A) required under section 314.520 or sec-
tion 601.42 of title 21, Code of Federal Regula-
tions; or 
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(B) otherwise agreed to by the applicant 
and the Secretary for such drug. 
(2) RISK EVALUATION AND MITIGATION STRAT-
EGY.—The approved risk evaluation and mitigation 
strategy deemed in effect for a drug under para-
graph (1) shall consist of the elements described in 
subparagraphs (A) and (B) of paragraph (3) of such 
section 505(o) and any other additional elements 
under paragraphs (4) and (5) in effect for such drug 
on the effective date of this title. 
(3) NOTIFICATION.—Not later than 30 days 
after the effective date of this title, the Secretary 
shall notify the applicant for each drug described in 
paragraph (1)— 
(A) that such drug is deemed to have an 
approved risk evaluation and mitigation strat-
egy pursuant to such paragraph; and 
(B) of the date, which shall be no earlier 
than 6 months after the applicant is so notified, 
by which the applicant shall submit to the Sec-
retary an assessment of such approved strategy 
under paragraph (6)(B) of such section 505(o). 
(c) OTHER DRUGS APPROVED BEFORE THE EFFEC-
TIVE DATE.—The Secretary, on a case-by-case basis, may 
require the applicant for a drug approved before the effec-
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tive date of this title to which subsection (b) does not 
apply to submit a proposed risk evaluation and mitigation 
strategy in accordance with the timeframes provided for 
in subclause (III), (IV), or (V), as applicable, of paragraph 
(6)(B)(ii) of such section 505(o) if the Secretary deter-
mines (with respect to such drug or with respect to the 
group of drugs to which such drug belongs) that— 
(1) an element described under paragraph 
(3)(A) of such section 505(o) may require modifica-
tion; or 
(2) a standard for adding an element described 
in paragraph (4) or (5) of such section 505(o) that 
is not in effect with respect to such drug or class of 
drugs may apply. 
(d) USE OF ADVISORY COMMITTEES; PROCESS FOR 
ADDRESSING DRUG CLASS EFFECTS.—In imposing a re-
quirement under subsection (c), the Secretary— 
(1) may convene a meeting of 1 or more advi-
sory committees of the Food and Drug Administra-
tion in accordance with paragraph (6)(G) of such 
section 505(o); and 
(2) may use the process described in paragraph 
(6)(H) of such section 505(o) (relating to addressing 
drug class effects). 
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SEC. 113. RULE OF CONSTRUCTION REGARDING PEDIATRIC 
STUDIES. 
Nothing in this Act or the amendments made by this 
Act shall be construed to affect the authority of the Sec-
retary or the Commissioner of Food and Drugs to require 
pediatric studies under section 505A of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355a). 
SEC. 114. AUTHORIZATION OF APPROPRIATIONS. 
(a) IN GENERAL.—For carrying out this title and the 
amendments made by this title, there is authorized to be 
appropriated $25,000,000 for each of fiscal years 2008 
through 2012. 
(b) RELATION TO OTHER FUNDING.—The authoriza-
tion of appropriations under subsection (a) is in addition 
to any other funds available for carrying out this title and 
the amendments made by this title. 
TITLE II—REAGAN-UDALL INSTI-
TUTE 
FOR 
APPLIED 
BIO-
MEDICAL RESEARCH 
SEC. 201. THE REAGAN-UDALL INSTITUTE FOR APPLIED 
BIOMEDICAL RESEARCH. 
(a) IN GENERAL.—Chapter VII of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 371 et seq.), as 
amended by Public Law 109–462, is amended by adding 
at the end the following: 
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‘‘Subchapter I—Reagan-Udall Institute for 
Applied Biomedical Research 
‘‘SEC. 770. ESTABLISHMENT AND FUNCTIONS OF THE INSTI-
TUTE. 
‘‘(a) IN GENERAL.—The Secretary shall establish a 
nonprofit corporation to be known as the Reagan-Udall 
Institute for Applied Biomedical Research (referred to in 
this subchapter as the ‘Institute’). The Institute shall be 
headed by an Executive Director, appointed by the mem-
bers of the Board of Directors under subsection (e). The 
Institute shall not be an agency or instrumentality of the 
United States Government. 
‘‘(b) PURPOSE OF INSTITUTE.—The purpose of the 
Institute is to advance the Critical Path Initiative of the 
Food and Drug Administration to modernize medical 
product development, accelerate innovation, and enhance 
product safety. 
‘‘(c) DUTIES
OF
THE INSTITUTE.—The Institute 
shall— 
‘‘(1) taking into consideration the 2004 report 
published by the Food and Drug Administration en-
titled ‘Innovation or Stagnation? Challenge and Op-
portunity on the Critical Path to New Medical Prod-
ucts’, identify unmet needs in the sciences of devel-
oping, manufacturing, and evaluating the safety and 
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effectiveness of diagnostics, devices, biologics, and 
drugs, including— 
‘‘(A) the identification and validation of 
biomarkers for use in diagnostic, device, bio-
logic, and drug development; 
‘‘(B) the development and validation of 
animal models for human disease and medical 
product safety; 
‘‘(C) pharmacogenomics and inter-indi-
vidual variability in drug, biologic, and device 
response; 
‘‘(D) the development of data analysis 
technology and methodology for use in device, 
biologic, drug, and diagnostic development; 
‘‘(E) advancing improvements to the de-
sign and conduct of clinical trials; 
‘‘(F) toxicological quality assessment tech-
nologies; 
‘‘(G) diagnostic, device, biologic, and drug 
manufacturing, design, and materials science; 
‘‘(H) failure mode assessment for medical 
product development; 
‘‘(I) improving adverse event reporting and 
analysis; 
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‘‘(J) bridging engineering data and clinical 
performance for devices; and 
‘‘(K) computer modeling; 
‘‘(2) establish goals and priorities in order to 
meet the unmet needs identified in paragraph (1); 
‘‘(3) in consultation with the Secretary, assess 
existing and proposed Federal intramural and extra-
mural research and development programs relating 
to the goals and priorities established under para-
graph (2) and facilitate and encourage interagency 
coordination of such programs; 
‘‘(4) award grants to, or enter into contracts or 
cooperative agreements with, scientists and entities 
to advance the goals and priorities established under 
paragraph (2); 
‘‘(5) recruit meeting participants and hold or 
sponsor (in whole or in part) meetings as appro-
priate to further the goals and priorities established 
under paragraph (2); 
‘‘(6) release and publish information and data 
and, to the extent practicable, license, distribute, 
and release material, reagents, and techniques to 
maximize, promote, and coordinate the availability of 
such material, reagents, and techniques for use by 
the Food and Drug Administration, nonprofit orga-
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nizations, and academic and industrial researchers 
to further the goals and priorities established under 
paragraph (2); 
‘‘(7) ensure that— 
‘‘(A) action is taken as necessary to obtain 
patents for inventions developed by the Insti-
tute or with funds from the Institute; 
‘‘(B) action is taken as necessary to enable 
the licensing of inventions developed by the In-
stitute or with funds from the Institute; and 
‘‘(C) executed licenses, memoranda of un-
derstanding, material transfer agreements, con-
tracts, and other such instruments promote, to 
the maximum extent practicable, the broadest 
conversion to commercial and noncommercial 
applications of licensed and patented inventions 
of the Institute to further the goals and prior-
ities established under paragraph (2); 
‘‘(8) provide objective clinical and scientific in-
formation to the Food and Drug Administration 
and, upon request, to other Federal agencies to as-
sist in agency determinations of how to ensure that 
regulatory policy accommodates scientific advances; 
‘‘(9) conduct annual assessments of the unmet 
needs identified in paragraph (1); and 
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‘‘(10) carry out such other activities consistent 
with the purposes of the Institute as the Board de-
termines appropriate. 
‘‘(d) BOARD OF DIRECTORS.— 
‘‘(1) ESTABLISHMENT.— 
‘‘(A) IN
GENERAL.—The Institute shall 
have a Board of Directors (referred to in this 
subchapter as the ‘Board’), which shall be com-
posed of ex officio and appointed members in 
accordance with this subsection. All appointed 
members of the Board shall be voting members. 
‘‘(B) EX OFFICIO MEMBERS.—The ex offi-
cio members of the Board shall be— 
‘‘(i) the immediate past Chair of the 
Board of Directors of the Institute; 
‘‘(ii) the Commissioner of Food and 
Drugs; 
‘‘(iii) the Director of the National In-
stitutes of Health; 
‘‘(iv) the Director of the Centers for 
Disease Control and Prevention; and 
‘‘(v) the Director of the Agency for 
Healthcare Research and Quality. 
‘‘(C) APPOINTED MEMBERS.— 
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‘‘(i) IN
GENERAL.—The ex officio 
members of the Board under subparagraph 
(B) shall, by majority vote, appoint to the 
Board 12 individuals. Of such appointed 
members— 
‘‘(I) 3 shall be representatives of 
the general pharmaceutical, device, 
and biotechnology industries; 
‘‘(II) 3 shall be representatives of 
academic research organizations; 
‘‘(III) 2 shall be representatives 
of Government agencies, including the 
Food and Drug Administration and 
the National Institutes of Health; 
‘‘(IV) 3 shall be representatives 
of patient advocacy and consumer or-
ganizations; and 
‘‘(V) 1 shall be a representative 
of health care providers. 
‘‘(ii) REQUIREMENT.—The ex officio 
members shall ensure the Board member-
ship includes individuals with expertise in 
areas including clinical pharmacology, bio-
medical informatics, product safety, proc-
ess 
improvement 
and 
pharmaceutical 
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sciences, and medical device and bio-
medical engineering. 
‘‘(D) INITIAL MEETING.— 
‘‘(i) IN GENERAL.—Not later than 30 
days after the date of the enactment of the 
Enhancing Drug Safety and Innovation 
Act of 2007, the Secretary shall convene a 
meeting of the ex officio members of the 
Board to— 
‘‘(I) incorporate the Institute; 
and 
‘‘(II) appoint the members of the 
Board in accordance with subpara-
graph (C). 
‘‘(ii) SERVICE OF EX OFFICIO MEM-
BERS.—Upon the appointment of the 
members of the Board under clause (i)(II), 
the terms of service of the ex officio mem-
bers of the Board as members of the 
Board shall terminate. 
‘‘(iii) CHAIR.—The ex officio members 
of the Board under subparagraph (B) shall 
designate an appointed member of the 
Board to serve as the Chair of the Board. 
‘‘(2) DUTIES OF BOARD.—The Board shall— 
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‘‘(A) establish bylaws for the Institute 
that— 
‘‘(i) are published in the Federal Reg-
ister and available for public comment; 
‘‘(ii) establish policies for the selection 
of the officers, employees, agents, and con-
tractors of the Institute; 
‘‘(iii) establish policies, including eth-
ical standards, for the acceptance, solicita-
tion, and disposition of donations and 
grants to the Institution and for the dis-
position of the assets of the Institute; 
‘‘(iv) establish policies whereby any 
individual who is an officer, employee, or 
member of the Board of the Institute may 
not personally or substantially participate 
in the consideration or determination by 
the Institute of any matter that would di-
rectly or predictably affect any financial 
interest of the individual or a relative (as 
such term is defined in section 109(16) of 
the Ethics in Government Act of 1978) of 
the individual, of any business organization 
or other entity, or of which the individual 
is an officer or employee or is negotiating 
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for employment, or in which the individual 
has any other financial interest; 
‘‘(v) establish licensing, distribution, 
and publication policies that support the 
widest and least restrictive use by the pub-
lic of information and inventions developed 
by the Institute or with Institute funds to 
carry out the duties described in para-
graphs (6) and (7) of subsection (c); 
‘‘(vi) specify principles for the review 
of proposals and awarding of grants and 
contracts that include peer review and that 
are substantially consistent with those of 
the Foundation for the National Institutes 
of Health; 
‘‘(vii) specify a process for annual 
Board review of the operations of the Insti-
tute; and 
‘‘(viii) establish specific duties of the 
Executive Director; 
‘‘(B) prioritize and provide overall direc-
tion to the activities of the Institute; 
‘‘(C) evaluate the performance of the Exec-
utive Director; and 
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