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‘‘(4) DISPUTE
RESOLUTION
AT
INITIAL
AP-
PROVAL.—If a proposed risk evaluation and mitiga-
tion strategy is submitted under subsection (a)(1) in 
an application for initial approval of a drug and 
there is a dispute about the strategy, the responsible 
person shall use the major dispute resolution proce-
dures as set forth in the letters described in section 
101(c) of the Food and Drug Administration 
Amendments Act of 2007. 
‘‘(5) DISPUTE
RESOLUTION
IN
ALL
OTHER 
CASES.— 
‘‘(A) REQUEST FOR REVIEW.— 
‘‘(i) IN GENERAL.—Not earlier than 
15 days, and not later than 35 days, after 
discussions under paragraph (2) have 
begun, the responsible person may request 
in writing that a dispute about the strat-
egy be reviewed by the Drug Safety Over-
sight Board under subsection (j), except 
that the determination of the Secretary to 
require a risk evaluation and mitigation 
strategy is not subject to review under this 
paragraph. The preceding sentence does 
not prohibit review under this paragraph of 
the particular elements of such a strategy. 
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‘‘(ii) SCHEDULING.—Upon receipt of 
a request under clause (i), the Secretary 
shall schedule the dispute involved for re-
view under subparagraph (B) 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. 
‘‘(B) SCHEDULING REVIEW.—If a respon-
sible person requests review under subpara-
graph (A), the Secretary— 
‘‘(i) shall schedule the dispute for re-
view at 1 of the next 2 regular meetings of 
the Drug Safety Oversight Board, which-
ever 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). 
‘‘(C) AGREEMENT AFTER DISCUSSION OR 
ADMINISTRATIVE APPEALS.— 
‘‘(i) FURTHER DISCUSSION OR ADMIN-
ISTRATIVE APPEALS.—A request for review 
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under subparagraph (A) shall not preclude 
further discussions to reach agreement on 
the risk evaluation 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, including ap-
peals as described in the letters described 
in section 101(c) of the Food and Drug 
Administration Amendments Act of 2007 
for procedural or scientific matters involv-
ing the review of human drug applications 
and supplemental applications that cannot 
be resolved at the divisional level. At the 
time a review has been scheduled under 
subparagraph (B) and notice of such re-
view has been posted, the responsible per-
son shall either withdraw the request 
under subparagraph (A) or terminate the 
use of such administrative appeals. 
‘‘(ii) AGREEMENT
TERMINATES
DIS-
PUTE RESOLUTION.—At any time before a 
decision and order is issued under sub-
paragraph (G) , the Secretary (in consulta-
tion with the offices described in sub-
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section (c)(2)) and the responsible person 
may reach an agreement on the risk eval-
uation and mitigation strategy through 
further discussion or administrative ap-
peals, terminating the dispute resolution 
process, and the Secretary shall issue an 
action letter or order, as appropriate, that 
describes the strategy. 
‘‘(D) MEETING
OF
THE
BOARD.—At a 
meeting of the Drug Safety Oversight Board 
described in subparagraph (B), the Board 
shall— 
‘‘(i) hear from both parties via written 
or oral presentation; and 
‘‘(ii) review the dispute. 
‘‘(E) RECORD
OF
PROCEEDINGS.—The 
Secretary shall ensure that the proceedings of 
any such meeting are recorded, transcribed, and 
made public within 90 days of the meeting. The 
Secretary shall redact the transcript to protect 
any trade secrets and other information that is 
exempted from disclosure under section 552 of 
title 5, United States Code, or section 552a of 
title 5, United States Code. 
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‘‘(F) 
RECOMMENDATION
OF
THE 
BOARD.—Not later than 5 days after any such 
meeting, the Drug Safety Oversight Board shall 
provide a written recommendation on resolving 
the dispute to the Secretary. Not later than 5 
days after the Board provides such written rec-
ommendation to the Secretary, the Secretary 
shall make the recommendation available to the 
public. 
‘‘(G) ACTION BY THE SECRETARY.— 
‘‘(i) ACTION
LETTER.—With respect 
to a proposal or assessment referred to in 
paragraph (1), the Secretary shall issue an 
action letter that resolves the dispute not 
later than the later of— 
‘‘(I) the action deadline for the 
action letter on the application; or 
‘‘(II) 7 days after receiving the 
recommendation of the Drug Safety 
Oversight Board. 
‘‘(ii) ORDER.—With respect to an as-
sessment of an approved risk evaluation 
and mitigation strategy under subsection 
(g)(1) or under any of subparagraphs (B) 
through (D) of subsection (g)(2), the Sec-
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retary shall issue an order, which shall be 
made public, that resolves the dispute not 
later than 7 days after receiving the rec-
ommendation of the Drug Safety Oversight 
Board. 
‘‘(H) INACTION.—An approved risk evalua-
tion and mitigation strategy shall remain in ef-
fect until the Secretary acts, if the Secretary 
fails to act as provided for under subparagraph 
(G). 
‘‘(I) EFFECT
ON
ACTION
DEADLINE.— 
With respect to a proposal or assessment re-
ferred to in paragraph (1), the Secretary shall 
be considered to have met the action deadline 
for the action letter on the application if the re-
sponsible person requests the dispute resolution 
process described in this paragraph and if the 
Secretary— 
‘‘(i) has initiated the discussions de-
scribed under paragraph (2) not less than 
60 days before such action deadline; and 
‘‘(ii) has complied with the timing re-
quirements of scheduling review by the 
Drug Safety Oversight Board, providing a 
written recommendation, and issuing an 
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action letter under subparagraphs (B), 
(F), and (G), respectively. 
‘‘(J) DISQUALIFICATION.—No individual 
who is an employee of the Food and Drug Ad-
ministration and who reviews a drug or who 
participated in an administrative appeal under 
subparagraph (C)(i) with respect to such drug 
may serve on the Drug Safety Oversight Board 
at a meeting under subparagraph (D) to review 
a dispute about the risk evaluation and mitiga-
tion strategy for such drug. 
‘‘(K) ADDITIONAL EXPERTISE.—The Drug 
Safety Oversight Board may add members with 
relevant expertise from the Food and Drug Ad-
ministration, 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 meeting 
under subparagraph (D) of the Drug Safety 
Oversight Board. 
‘‘(6) USE
OF
ADVISORY
COMMITTEES.—The 
Secretary may convene a meeting of 1 or more advi-
sory committees of the Food and Drug Administra-
tion to— 
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‘‘(A) review a concern about the safety of 
a drug or class of drugs, including before an as-
sessment of the risk evaluation and mitigation 
strategy or strategies of such drug or drugs is 
required to be submitted under any of subpara-
graphs (B) through (D) of subsection (g)(2); 
‘‘(B) review the risk evaluation and mitiga-
tion strategy or strategies of a drug or group 
of drugs; or 
‘‘(C) review a dispute under paragraph (4) 
or (5). 
‘‘(7) PROCESS FOR ADDRESSING DRUG CLASS 
EFFECTS.— 
‘‘(A) IN GENERAL.—When a concern about 
a serious risk of a drug may be related to the 
pharmacological class of the drug, the Sec-
retary, in consultation with the offices described 
in subsection (c)(2), may defer assessments of 
the approved risk evaluation and mitigation 
strategies for such drugs until the Secretary 
has convened 1 or more public meetings to con-
sider possible responses to such concern. 
‘‘(B) NOTICE.—If the Secretary defers an 
assessment under subparagraph (A), the Sec-
retary shall— 
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‘‘(i) give notice of the deferral to the 
holder of the approved covered application 
not later than 5 days after the deferral; 
‘‘(ii) publish the deferral in the Fed-
eral Register; and 
‘‘(iii) give notice to the public of any 
public meetings to be convened under sub-
paragraph (A), including a description of 
the deferral. 
‘‘(C) PUBLIC
MEETINGS.—Such public 
meetings may include— 
‘‘(i) 1 or more meetings of the respon-
sible person for such drugs; 
‘‘(ii) 1 or more meetings of 1 or more 
advisory committees of the Food and Drug 
Administration, as provided for under 
paragraph (6); or 
‘‘(iii) 1 or more workshops of sci-
entific experts and other stakeholders. 
‘‘(D) ACTION.—After considering the dis-
cussions from any meetings under subpara-
graph (A), the Secretary may— 
‘‘(i) announce in the Federal Register 
a planned regulatory action, including a 
modification to each risk evaluation and 
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mitigation strategy, for drugs in the phar-
macological class; 
‘‘(ii) seek public comment about such 
action; and 
‘‘(iii) after seeking such comment, 
issue an order addressing such regulatory 
action. 
‘‘(8) 
INTERNATIONAL
COORDINATION.—The 
Secretary, in consultation with the offices described 
in subsection (c)(2), may coordinate the timetable 
for submission of assessments under subsection (d), 
or a study or clinical trial under section 505(o)(3), 
with efforts to identify and assess the serious risks 
of such drug by the marketing authorities of other 
countries whose drug approval and risk management 
processes the Secretary deems comparable to the 
drug approval and risk management processes of the 
United States. If the Secretary takes action to co-
ordinate such timetable, the Secretary shall give no-
tice to the responsible person. 
‘‘(9) EFFECT.—Use of the processes described 
in paragraphs (7) and (8) shall not be the sole 
source of delay of action on an application or a sup-
plement to an application for a drug. 
‘‘(i) ABBREVIATED NEW DRUG APPLICATIONS.— 
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‘‘(1) IN GENERAL.—A drug that is the subject 
of an abbreviated new drug application under section 
505(j) is subject to only the following elements of 
the risk evaluation and mitigation strategy required 
under subsection (a) for the applicable listed drug: 
‘‘(A) A Medication Guide or patient pack-
age insert, if required under subsection (e) for 
the applicable listed drug. 
‘‘(B) Elements to assure safe use, if re-
quired under subsection (f) for the listed drug. 
A drug that is the subject of an abbreviated 
new drug application and the listed drug shall 
use a single, shared system under subsection 
(f). The Secretary may waive the requirement 
under the preceding sentence for a drug that is 
the subject of an abbreviated new drug applica-
tion, and permit the applicant to use a dif-
ferent, comparable aspect of the elements to as-
sure safe use, if the Secretary determines 
that— 
‘‘(i) the burden of creating a single, 
shared system outweighs the benefit of a 
single, system, taking into consideration 
the impact on health care providers, pa-
tients, the applicant for the abbreviated 
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new drug application, and the holder of the 
reference drug product; or 
‘‘(ii) an aspect of the elements to as-
sure safe use for the applicable listed drug 
is claimed by a patent that has not expired 
or is a method or process that, as a trade 
secret, is entitled to protection, and the ap-
plicant for the abbreviated new drug appli-
cation certifies that it has sought a license 
for use of an aspect of the elements to as-
sure safe use for the applicable listed drug 
and that it was unable to obtain a license. 
A certification under clause (ii) shall include a 
description of the efforts made by the applicant 
for the abbreviated new drug application to ob-
tain a license. In a case described in clause (ii), 
the Secretary may seek to negotiate a voluntary 
agreement with the owner of the patent, meth-
od, or process for a license under which the ap-
plicant for such abbreviated new drug applica-
tion may use an aspect of the elements to as-
sure safe use, if required under subsection (f) 
for the applicable listed drug, that is claimed by 
a patent that has not expired or is a method or 
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including the offices responsible for post-
approval safety of drugs; 
‘‘(C) include at least 1 representative each 
from the National Institutes of Health and the 
Department of Health and Human Services 
(other than the Food and Drug Administra-
tion); 
‘‘(D) include such representatives as the 
Secretary shall designate from other appro-
priate agencies that wish to provide representa-
tives; and 
‘‘(E) meet at least monthly to provide 
oversight and advice to the Secretary on the 
management of important drug safety issues.’’. 
(c) REGULATION OF BIOLOGICAL PRODUCTS.—Sec-
tion 351 of the Public Health Service Act (42 U.S.C. 262) 
is amended— 
(1) in subsection (a)(2), by adding at the end 
the following: 
‘‘(D) POSTMARKET STUDIES AND CLINICAL TRIALS; 
LABELING; RISK EVALUATION AND MITIGATION STRAT-
EGY.—A person that submits an application for a license 
under this paragraph is subject to sections 505(o), 505(p), 
and 505–1 of the Federal Food, Drug, and Cosmetic 
Act.’’; and 
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(2) in subsection (j), by inserting ‘‘, including 
the requirements under sections 505(o), 505(p), and 
505–1 of such Act,’’ after ‘‘, and Cosmetic Act’’. 
(d) ADVERTISEMENTS
OF
DRUGS.—The Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), 
as amended by section 801(b), is amended— 
(1) in section 301 (21 U.S.C. 331), by adding 
at the end the following: 
‘‘(kk) The dissemination of a television advertisement 
without complying with section 503B.’’; and 
(2) by inserting after section 503A the fol-
lowing: 
‘‘SEC. 503B. PREREVIEW OF TELEVISION ADVERTISEMENTS. 
‘‘(a) IN GENERAL.—The Secretary may require the 
submission of any television advertisement for a drug (in-
cluding any script, story board, rough, or a completed 
video production of the television advertisement) to the 
Secretary for review under this section not later than 45 
days before dissemination of the television advertisement. 
‘‘(b) REVIEW.—In conducting a review of a television 
advertisement under this section, the Secretary may make 
recommendations with respect to information included in 
the label of the drug— 
‘‘(1) on changes that are— 
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‘‘(A) necessary to protect the consumer 
good and well-being; or 
‘‘(B) consistent with prescribing informa-
tion for the product under review; and 
‘‘(2) if appropriate and if information exists, on 
statements for inclusion in the advertisement to ad-
dress the specific efficacy of the drug as it relates 
to specific population groups, including elderly popu-
lations, children, and racial and ethnic minorities. 
‘‘(c) NO AUTHORITY TO REQUIRE CHANGES.—Ex-
cept as provided by subsection (e), this section does not 
authorize the Secretary to make or direct changes in any 
material submitted pursuant to subsection (a). 
‘‘(d) ELDERLY POPULATIONS, CHILDREN, RACIALLY 
AND ETHNICALLY DIVERSE COMMUNITIES.—In formu-
lating recommendations under subsection (b), the Sec-
retary shall take into consideration the impact of the ad-
vertised drug on elderly populations, children, and racially 
and ethnically diverse communities. 
‘‘(e) SPECIFIC DISCLOSURES.— 
‘‘(1) SERIOUS
RISK; SAFETY
PROTOCOL.—In 
conducting a review of a television advertisement 
under this section, if the Secretary determines that 
the advertisement would be false or misleading with-
out a specific disclosure about a serious risk listed 
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in the labeling of the drug involved, the Secretary 
may require inclusion of such disclosure in the ad-
vertisement. 
‘‘(2) DATE OF APPROVAL.—In conducting a re-
view of a television advertisement under this section, 
the Secretary may require the advertisement to in-
clude, for a period not to exceed 2 years from the 
date of the approval of the drug under section 505 
or section 351 of the Public Health Service Act, a 
specific disclosure of such date of approval if the 
Secretary determines that the advertisement would 
otherwise be false or misleading. 
‘‘(f) RULE OF CONSTRUCTION.—Nothing in this sec-
tion may be construed as having any effect on require-
ments under section 502(n) or on the authority of the Sec-
retary under section 314.550, 314.640, 601.45, or 601.94 
of title 21, Code of Federal Regulations (or successor reg-
ulations).’’. 
(3) DIRECT-TO-CONSUMER ADVERTISEMENTS.— 
(A) IN GENERAL.—Section 502(n) of the 
Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 352(n)) is amended by adding at the 
end the following: ‘‘In the case of an advertise-
ment for a drug subject to section 503(b)(1) 
presented directly to consumers in television or 
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radio format and stating the name of the drug 
and its conditions of use, the major statement 
relating to side effects and contraindications 
shall be presented in a clear, conspicuous, and 
neutral manner.’’. 
(B) REGULATIONS TO DETERMINE CLEAR, 
CONSPICUOUS, AND
NEUTRAL
MANNER.—Not 
later than 30 months after the date of the en-
actment of the Food and Drug Administration 
Amendments Act of 2007, the Secretary of 
Health and Human Services shall by regulation 
establish standards for determining whether a 
major statement relating to side effects and 
contraindications of a drug, described in section 
502(n) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 352(n)) (as amended by 
subparagraph (A)) is presented in the manner 
required under such section. 
(4) CIVIL PENALTIES.—Section 303 of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 333), 
as amended by section 801(b), is amended by adding 
at the end the following: 
‘‘(g)(1) With respect to a person who is a holder of 
an approved application under section 505 for a drug sub-
ject to section 503(b) or under section 351 of the Public 
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beginning on the date the order making such assessments 
was issued. 
‘‘(7) If any person fails to pay an assessment of a 
civil penalty under paragraph (1)— 
‘‘(A) after the order making the assessment be-
comes final, and if such person does not file a peti-
tion for judicial review of the order in accordance 
with paragraph (6), or 
‘‘(B) after a court in an action brought under 
paragraph (6) has entered a final judgment in favor 
of the Secretary, 
the Attorney General of the United States shall recover 
the amount assessed (plus interest at currently prevailing 
rates from the date of the expiration of the 60-day period 
referred to in paragraph (6) or the date of such final judg-
ment, as the case may be) in an action brought in any 
appropriate district court of the United States. In such 
an action, the validity, amount, and appropriateness of 
such penalty shall not be subject to review.’’. 
(5) REPORT ON DIRECT-TO-CONSUMER ADVER-
TISING.—Not later than 24 months after the date of 
the enactment of this Act, the Secretary of Health 
and Human Services shall report to the Congress on 
direct-to-consumer advertising and its ability to com-
municate to subsets of the general population, in-
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cluding elderly populations, children, and racial and 
ethnic minority communities. The Secretary shall 
utilize the Advisory Committee on Risk Communica-
tion established under this Act to advise the Sec-
retary with respect to such report. The Advisory 
Committee shall study direct-to-consumer adver-
tising as it relates to increased access to health in-
formation and decreased health disparities for these 
populations. The report required by this paragraph 
shall recommend effective ways to present and dis-
seminate information to these populations. Such re-
port shall also make recommendations regarding im-
pediments to the participation of elderly populations, 
children, racially and ethnically diverse communities, 
and medically underserved populations in clinical 
drug trials and shall recommend best practice ap-
proaches for increasing the inclusion of such subsets 
of the general population. The Secretary of Health 
and Human Services shall submit the report under 
this paragraph to the Committee on Health, Edu-
cation, Labor, and Pensions of the Senate and the 
Committee on Energy and Commerce of the House 
of Representatives. 
(6) RULEMAKING.—Section 502(n) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 
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352(n)) is amended by striking ‘‘the procedure spec-
ified in section 701(e) of this Act’’ and inserting 
‘‘section 701(a)’’. 
(e) RULE OF CONSTRUCTION REGARDING PEDIATRIC 
STUDIES.—This title and the amendments made by this 
title may not be construed as affecting the authority of 
the Secretary of Health and Human Services to request 
pediatric studies under section 505A of the Federal Food, 
Drug, and Cosmetic Act or to require such studies under 
section 505B of such Act. 
SEC. 902. 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 pursuant to section 505(p) 
and the responsible person (as such term is used in section 
505–1) fails to comply with a requirement of such strategy 
provided for under subsection (d), (e), or (f) of section 
505–1. 
‘‘(z) If it is a drug, and the responsible person (as 
such term is used in section 505(o)) is in violation of a 
requirement established under paragraph (3) (relating to 
postmarket studies and clinical trials) or paragraph (4) 
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(relating to labeling) of section 505(o) with respect to such 
drug.’’. 
(b) CIVIL PENALTIES.—Section 303(f) of the Federal 
Food, Drug, and Cosmetic Act, as amended by section 
801(b), is amended— 
(1) by inserting after paragraph (3), as added 
by section 801(b)(2), the following: 
‘‘(4)(A) Any responsible person (as such term is used 
in section 505–1) that violates a requirement of section 
505(o), 505(p), or 505–1 shall be subject to a civil mone-
tary penalty of— 
‘‘(i) not more than $250,000 per violation, and 
not to exceed $1,000,000 for all such violations ad-
judicated in a single proceeding; or 
‘‘(ii) in the case of a violation that continues 
after the Secretary provides written notice to the re-
sponsible person, the responsible person shall be sub-
ject to a civil monetary penalty of $250,000 for the 
first 30-day period (or any portion thereof) that the 
responsible person continues to be in violation, and 
such amount shall double for every 30-day period 
thereafter that the violation continues, not to exceed 
$1,000,000 for any 30-day period, and not to exceed 
$10,000,000 for all such violations adjudicated in a 
single proceeding. 
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‘‘(B) In determining the amount of a civil penalty 
under subparagraph (A)(ii), the Secretary shall take into 
consideration whether the responsible person is making ef-
forts toward correcting the violation of the requirement 
of section 505(o), 505(p), or 505–1 for which the respon-
sible person is subject to such civil penalty.’’; and 
(2) in paragraph (5), as redesignated by section 
801(b)(2)(A), by striking ‘‘paragraph (1), (2), or 
(3)’’ each place it appears and inserting ‘‘paragraph 
(1), (2), (3), or (4)’’. 
SEC. 903. 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 section 
505–1(g)(2)(D).’’. 
SEC. 904. 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-
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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. As part of such study, 
the Commissioner may consider the possibility of including 
in the labeling and any direct-to-consumer advertisements 
of a newly approved drug or indication a unique symbol 
indicating the newly approved status of the drug or indica-
tion for a period after approval. 
SEC. 905. ACTIVE POSTMARKET RISK IDENTIFICATION AND 
ANALYSIS. 
(a) IN GENERAL.—Subsection (k) of section 505 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355) is amended by adding at the end the following: 
‘‘(3) ACTIVE
POSTMARKET
RISK
IDENTIFICA-
TION.— 
‘‘(A) DEFINITION.—In this paragraph, the 
term ‘data’ refers to information with respect to 
a drug approved under this section or under 
section 351 of the Public Health Service Act, 
including claims data, patient survey data, 
standardized analytic files that allow for the 
pooling and analysis of data from disparate 
data environments, and any other data deemed 
appropriate by the Secretary. 
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‘‘(B) DEVELOPMENT
OF
POSTMARKET 
RISK
IDENTIFICATION
AND
ANALYSIS
METH-
ODS.—The Secretary shall, not later than 2 
years after the date of the enactment of the 
Food and Drug Administration Amendments 
Act of 2007, in collaboration with public, aca-
demic, and private entities— 
‘‘(i) develop methods to obtain access 
to disparate data sources including the 
data sources specified in subparagraph 
(C); 
‘‘(ii) develop validated methods for the 
establishment of a postmarket risk identi-
fication and analysis system to link and 
analyze safety data from multiple sources, 
with the goals of including, in aggregate— 
‘‘(I) at least 25,000,000 patients 
by July 1, 2010; and 
‘‘(II) at least 100,000,000 pa-
tients by July 1, 2012; and 
‘‘(iii) convene a committee of experts, 
including individuals who are recognized in 
the field of protecting data privacy and se-
curity, to make recommendations to the 
Secretary on the development of tools and 
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methods for the ethical and scientific uses 
for, and communication of, postmarketing 
data specified under subparagraph (C), in-
cluding recommendations on the develop-
ment of effective research methods for the 
study of drug safety questions. 
‘‘(C) 
ESTABLISHMENT
OF
THE 
POSTMARKET RISK IDENTIFICATION AND ANAL-
YSIS SYSTEM.— 
‘‘(i) IN
GENERAL.—The Secretary 
shall, not later than 1 year after the devel-
opment of the risk identification and anal-
ysis methods under subparagraph (B), es-
tablish and maintain procedures— 
‘‘(I) for risk identification and 
analysis based on electronic health 
data, in compliance with the regula-
tions 
promulgated 
under 
section 
264(c) of the Health Insurance Port-
ability and Accountability Act of 
1996, and in a manner that does not 
disclose individually identifiable health 
information in violation of paragraph 
(4)(B); 
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‘‘(II) for the reporting (in a 
standardized form) of data on all seri-
ous adverse drug experiences (as de-
fined in section 505–1(b)) submitted 
to the Secretary under paragraph (1), 
and those adverse events submitted by 
patients, providers, and drug spon-
sors, when appropriate; 
‘‘(III) to provide for active ad-
verse event surveillance using the fol-
lowing data sources, as available: 
‘‘(aa) Federal health-related 
electronic data (such as data 
from the Medicare program and 
the health systems of the Depart-
ment of Veterans Affairs); 
‘‘(bb) private sector health- 
related electronic data (such as 
pharmaceutical 
purchase 
data 
and 
health 
insurance 
claims 
data); and 
‘‘(cc) other data as the Sec-
retary deems necessary to create 
a robust system to identify ad-
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verse events and potential drug 
safety signals; 
‘‘(IV) to identify certain trends 
and patterns with respect to data 
accessed by the system; 
‘‘(V) to provide regular reports to 
the 
Secretary 
concerning 
adverse 
event trends, adverse event patterns, 
incidence and prevalence of adverse 
events, and other information the Sec-
retary determines appropriate, which 
may include data on comparative na-
tional adverse event trends; and 
‘‘(VI) to enable the program to 
export data in a form appropriate for 
further aggregation, statistical anal-
ysis, and reporting. 
‘‘(ii) TIMELINESS
OF
REPORTING.— 
The procedures established under clause (i) 
shall ensure that such data are accessed, 
analyzed, and reported in a timely, routine, 
and systematic manner, taking into consid-
eration the need for data completeness, 
coding, cleansing, and standardized anal-
ysis and transmission. 
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‘‘(iii) PRIVATE SECTOR RESOURCES.— 
To ensure the establishment of the active 
postmarket risk identification and analysis 
system under this subsection not later than 
1 year after the development of the risk 
identification and analysis methods under 
subparagraph (B), as required under 
clause (i), the Secretary may, on a tem-
porary or permanent basis, implement sys-
tems or products developed by private enti-
ties. 
‘‘(iv) 
COMPLEMENTARY
AP-
PROACHES.—To the extent the active 
postmarket risk identification and analysis 
system under this subsection is not suffi-
cient to gather data and information rel-
evant to a priority drug safety question, 
the Secretary shall develop, support, and 
participate in complementary approaches 
to gather and analyze such data and infor-
mation, including— 
‘‘(I) approaches that are com-
plementary with respect to assessing 
the safety of use of a drug in domestic 
populations not included, or underrep-
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and other key stakeholders, and to the extent 
practicable shall coordinate with the activities 
of private entities, professional associations, or 
other entities that may have sources of drug 
safety data.’’. 
(b) RULE OF CONSTRUCTION.—Nothing in this sec-
tion or the amendment made by this section shall be con-
strued to prohibit the lawful disclosure or use of data or 
information by an entity other than as described in para-
graph (4)(B) or (4)(G) of section 505(k) of the Federal 
Food, Drug, and Cosmetic Act, as added by subsection 
(a). 
(c) REPORT TO CONGRESS.—Not later than 4 years 
after the date of the enactment of this Act, the Secretary 
shall report to the Congress on the ways in which the Sec-
retary has used the active postmarket risk identification 
and analysis system described in paragraphs (3) and (4) 
of section 505(k) of the Federal Food, Drug, and Cos-
metic Act, as added by subsection (a), to identify specific 
drug safety signals and to better understand the outcomes 
associated with drugs marketed in the United States. 
(d) AUTHORIZATION OF APPROPRIATIONS.—To carry 
out activities under the amendment made by this section 
for which funds are made available under section 736 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
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379h), there are authorized to be appropriated to carry 
out the amendment made by this section, in addition to 
such funds, $25,000,000 for each of fiscal years 2008 
through 2012. 
(e) GAO REPORT.—Not later than 18 months after 
the date of the enactment of this Act, the Comptroller 
General of the United States shall evaluate data privacy, 
confidentiality, and security issues relating to accessing, 
transmitting, and maintaining data for the active 
postmarket risk identification and analysis system de-
scribed in paragraphs (3) and (4) of section 505(k) of the 
Federal Food, Drug, and Cosmetic Act, as added by sub-
section (a), and make recommendations 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, and any other congressional commit-
tees of relevant jurisdiction, regarding the need for any 
additional legislative or regulatory actions to ensure pri-
vacy, confidentiality, and security of this data or otherwise 
address privacy, confidentiality, and security issues to en-
sure the effective operation of such active postmarket 
identification and analysis system. 
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SEC. 906. STATEMENT FOR INCLUSION IN DIRECT-TO-CON-
SUMER ADVERTISEMENTS OF DRUGS. 
(a) PUBLISHED DIRECT-TO-CONSUMER ADVERTISE-
MENTS.—Section 502(n) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 352), as amended by section 
901(d)(6), is further amended by inserting ‘‘and in the 
case of published direct-to-consumer advertisements the 
following statement printed in conspicuous text: ‘You are 
encouraged to report negative side effects of prescription 
drugs to the FDA. Visit www.fda.gov/medwatch, or call 
1–800-FDA-1088.’,’’ after ‘‘section 701(a),’’. 
(b) STUDY.— 
(1) IN GENERAL.—In the case of direct-to-con-
sumer television advertisements, the Secretary of 
Health and Human Services, in consultation with 
the Advisory Committee on Risk Communication 
under section 567 of the Federal Food, Drug, and 
Cosmetic Act (as added by section 917), shall, not 
later than 6 months after the date of the enactment 
of this Act, conduct a study to determine if the 
statement in section 502(n) of such Act (as added 
by subsection (a)) required with respect to published 
direct-to-consumer advertisements is appropriate for 
inclusion in such television advertisements. 
(2) CONTENT.—As part of the study under 
paragraph (1), such Secretary shall consider whether 
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the information in the statement described in para-
graph (1) would detract from the presentation of 
risk information in a direct-to-consumer television 
advertisement. If such Secretary determines the in-
clusion of such statement is appropriate in direct-to- 
consumer television advertisements, such Secretary 
shall issue regulations requiring the implementation 
of such statement in direct-to-consumer television 
advertisements, including determining a reasonable 
length of time for displaying the statement in such 
advertisements. The Secretary shall report to the ap-
propriate committees of Congress the findings of 
such study and any plans to issue regulations under 
this paragraph. 
SEC. 907. NO EFFECT ON VETERINARY MEDICINE. 
This subtitle, and the amendments made by this sub-
title, shall have no effect on the use of drugs approved 
under section 505 of the Federal Food, Drug, and Cos-
metic Act by, or on the lawful written or oral order of, 
a licensed veterinarian within the context of a veteri-
narian-client-patient relationship, as provided for under 
section 512(a)(5) of such Act. 
SEC. 908. AUTHORIZATION OF APPROPRIATIONS. 
(a) IN GENERAL.—For carrying out this subtitle and 
the amendments made by this subtitle, there is authorized 
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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 subtitle 
and the amendments made by this subtitle. 
SEC. 909. EFFECTIVE DATE AND APPLICABILITY. 
(a) EFFECTIVE DATE.—This subtitle takes effect 
180 days after the date of the 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 Act is, in accordance 
with paragraph (2), deemed to have in effect an ap-
proved risk evaluation and mitigation strategy under 
section 505–1 of the Federal Food, Drug, and Cos-
metic Act (as added by section 901) (referred to in 
this section as the ‘‘Act’’) if there are in effect on 
the effective date of this Act elements to assure safe 
use— 
(A) required under section 314.520 or sec-
tion 601.42 of title 21, Code of Federal Regula-
tions; or 
(B) otherwise agreed to by the applicant 
and the Secretary for such drug. 
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(2) 
ELEMENTS
OF
STRATEGY; 
ENFORCE-
MENT.—The approved risk evaluation and mitigation 
strategy in effect for a drug under paragraph (1)— 
(A) is deemed to consist of the timetable 
required under section 505–1(d) and any addi-
tional elements under subsections (e) and (f) of 
such section in effect for such drug on the ef-
fective date of this Act; and 
(B) is subject to enforcement by the Sec-
retary to the same extent as any other risk 
evaluation and mitigation strategy under sec-
tion 505–1 of the Act, except that sections 
303(f)(4) and 502(y) and (z) of the Act (as 
added by section 902) shall not apply to such 
strategy before the Secretary has completed re-
view of, and acted on, the first assessment of 
such strategy under such section 505–1. 
(3) SUBMISSION.—Not later than 180 days 
after the effective date of this Act, the holder of an 
approved application for which a risk evaluation and 
mitigation strategy is deemed to be in effect under 
paragraph (1) shall submit to the Secretary a pro-
posed risk evaluation and mitigation strategy. Such 
proposed strategy is subject to section 505–1 of the 
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Act as if included in such application at the time of 
submission of the application to the Secretary. 
Subtitle B—Other Provisions to En-
sure Drug Safety and Surveil-
lance 
SEC. 911. CLINICAL TRIAL GUIDANCE FOR ANTIBIOTIC 
DRUGS. 
Chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 351 et seq.) is amended by inserting after 
section 510 the following: 
‘‘SEC. 511. CLINICAL TRIAL GUIDANCE FOR ANTIBIOTIC 
DRUGS. 
‘‘(a) IN GENERAL.—Not later than 1 year after the 
date of the enactment of this section, the Secretary shall 
issue guidance for the conduct of clinical trials with re-
spect to antibiotic drugs, including antimicrobials to treat 
acute bacterial sinusitis, acute bacterial otitis media, and 
acute bacterial exacerbation of chronic bronchitis. Such 
guidance shall indicate the appropriate models and valid 
surrogate markers. 
‘‘(b) REVIEW.—Not later than 5 years after the date 
of the enactment of this section, the Secretary shall review 
and update the guidance described under subsection (a) 
to reflect developments in scientific and medical informa-
tion and technology.’’. 
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SEC. 912. PROHIBITION AGAINST FOOD TO WHICH DRUGS 
OR 
BIOLOGICAL 
PRODUCTS 
HAVE 
BEEN 
ADDED. 
(a) PROHIBITION.—Section 301 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 331), as amended by 
section 901(d), is amended by adding at the end the fol-
lowing: 
‘‘(ll) The introduction or delivery for introduction 
into interstate commerce of any food to which has been 
added a drug approved under section 505, a biological 
product licensed under section 351 of the Public Health 
Service Act, or a drug or a biological product for which 
substantial clinical investigations have been instituted and 
for which the existence of such investigations has been 
made public, unless— 
‘‘(1) such drug or such biological product was 
marketed in food before any approval of the drug 
under section 505, before licensure of the biological 
product under such section 351, and before any sub-
stantial clinical investigations involving the drug or 
the biological product have been instituted; 
‘‘(2) the Secretary, in the Secretary’s discre-
tion, has issued a regulation, after notice and com-
ment, approving the use of such drug or such bio-
logical product in the food; 
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‘‘(3) the use of the drug or the biological prod-
uct in the food is to enhance the safety of the food 
to which the drug or the biological product is added 
or applied and not to have independent biological or 
therapeutic effects on humans, and the use is in con-
formity with— 
‘‘(A) a regulation issued under section 409 
prescribing conditions of safe use in food; 
‘‘(B) a regulation listing or affirming con-
ditions under which the use of the drug or the 
biological product in food is generally recog-
nized as safe; 
‘‘(C) the conditions of use identified in a 
notification to the Secretary of a claim of ex-
emption from the premarket approval require-
ments for food additives based on the notifier’s 
determination that the use of the drug or the 
biological product in food is generally recog-
nized as safe, provided that the Secretary has 
not questioned the general recognition of safety 
determination in a letter to the notifier; 
‘‘(D) a food contact substance notification 
that is effective under section 409(h); or 
‘‘(E) such drug or biological product had 
been marketed for smoking cessation prior to 
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the date of the enactment of the Food and 
Drug Administration Amendments Act of 2007; 
or 
‘‘(4) the drug is a new animal drug whose use 
is not unsafe under section 512.’’. 
(b) CONFORMING CHANGES.—The Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) is amend-
ed— 
(1) in section 304(a)(1), by striking ‘‘section 
404 or 505’’ and inserting ‘‘section 301(ll), 404, or 
505’’; and 
(2) in section 801(a), by striking ‘‘is adulter-
ated, misbranded, or in violation of section 505,’’ 
and inserting ‘‘is adulterated, misbranded, or in vio-
lation of section 505, or prohibited from introduction 
or delivery for introduction into interstate commerce 
under section 301(ll),’’. 
SEC. 913. ASSURING PHARMACEUTICAL SAFETY. 
Chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 351 et seq.), as amended in section 403, 
is amended by inserting after section 505C the following: 
‘‘SEC. 505D. PHARMACEUTICAL SECURITY. 
‘‘(a) IN GENERAL.—The Secretary shall develop 
standards and identify and validate effective technologies 
for the purpose of securing the drug supply chain against 
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counterfeit, diverted, subpotent, substandard, adulterated, 
misbranded, or expired drugs. 
‘‘(b) STANDARDS DEVELOPMENT.— 
‘‘(1) IN GENERAL.—The Secretary shall, in con-
sultation with the agencies specified in paragraph 
(4), manufacturers, distributors, pharmacies, and 
other supply chain stakeholders, prioritize and de-
velop standards for the identification, validation, au-
thentication, and tracking and tracing of prescrip-
tion drugs. 
‘‘(2) STANDARDIZED NUMERAL IDENTIFIER.— 
Not later than 30 months after the date of the en-
actment of the Food and Drug Administration 
Amendments Act of 2007, the Secretary shall de-
velop a standardized numerical identifier (which, to 
the extent practicable, shall be harmonized with 
international consensus standards for such an identi-
fier) to be applied to a prescription drug at the point 
of manufacturing and repackaging (in which case 
the numerical identifier shall be linked to the numer-
ical identifier applied at the point of manufacturing) 
at the package or pallet level, sufficient to facilitate 
the identification, validation, authentication, and 
tracking and tracing of the prescription drug. 
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‘‘(3) PROMISING TECHNOLOGIES.—The stand-
ards developed under this subsection shall address 
promising technologies, which may include— 
‘‘(A) radio frequency identification tech-
nology; 
‘‘(B) nanotechnology; 
‘‘(C) encryption technologies; and 
‘‘(D) other track-and-trace or authentica-
tion technologies. 
‘‘(4) INTERAGENCY COLLABORATION.—In car-
rying out this subsection, the Secretary shall consult 
with Federal health and security agencies, includ-
ing— 
‘‘(A) the Department of Justice; 
‘‘(B) the Department of Homeland Secu-
rity; 
‘‘(C) the Department of Commerce; and 
‘‘(D) other appropriate Federal and State 
agencies. 
‘‘(c) INSPECTION AND ENFORCEMENT.— 
‘‘(1) IN GENERAL.—The Secretary shall expand 
and enhance the resources and facilities of agency 
components of the Food and Drug Administration 
involved with regulatory and criminal enforcement of 
this Act to secure the drug supply chain against 
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food after the responsible party has submitted a re-
port to the Food and Drug Administration under 
paragraph (1) with respect to such article of food— 
‘‘(A) the responsible party is not required 
to submit an additional report or make a notifi-
cation under paragraph (7); and 
‘‘(B) the responsible party shall amend the 
report submitted by the responsible party under 
paragraph (1) to include the data elements de-
scribed in paragraph (9), and, with respect to 
both such notification and such report, para-
graph (11) of subsection (e). 
‘‘(e) DATA ELEMENTS.—The data elements described 
in this subsection are the following: 
‘‘(1) The registration numbers of the respon-
sible party under section 415(a)(3). 
‘‘(2) The date on which an article of food was 
determined to be a reportable food. 
‘‘(3) A description of the article of food includ-
ing the quantity or amount. 
‘‘(4) The extent and nature of the adulteration. 
‘‘(5) If the adulteration of the article of food 
may have originated with the responsible party, the 
results of the investigation required under paragraph 
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