H. R. 3580—121 
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 amended by adding at the end 
the following: 
‘‘(y) If it is a drug subject to an approved risk evaluation 
and mitigation strategy pursuant to section 505(p) and the respon-
sible 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) (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 monetary penalty of— 
‘‘(i) not more than $250,000 per violation, and not to exceed 
$1,000,000 for all such violations adjudicated in a single pro-
ceeding; or 
‘‘(ii) in the case of a violation that continues after the 
Secretary provides written notice to the responsible person, 
the responsible person shall be subject 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 viola-
tions adjudicated in a single proceeding. 
‘‘(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 efforts toward correcting 
the violation of the requirement of section 505(o), 505(p), or 505– 
1 for which the responsible 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 Cosmetic 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 sub-
mitted under this section, or suspend the approval of such an 
application, as provided under this subsection, without first ordering 
the applicant to submit an assessment of the approved risk evalua-
tion and mitigation strategy for the drug under section 505– 
1(g)(2)(D).’’.
H. R. 3580—122 
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 communicate 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 IDENTIFICATION.— 
‘‘(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. 
‘‘(B) DEVELOPMENT OF POSTMARKET RISK IDENTIFICA-
TION
AND
ANALYSIS
METHODS.—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, academic, 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 establish-
ment of a postmarket risk identification 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 patients by July 1, 
2012; and 
‘‘(iii) convene a committee of experts, including 
individuals who are recognized in the field of protecting 
data privacy and security, to make recommendations 
to the Secretary on the development of tools and 
methods for the ethical and scientific uses for, and 
communication of, postmarketing data specified under 
subparagraph (C), including recommendations on the 
development of effective research methods for the study 
of drug safety questions. 
‘‘(C) ESTABLISHMENT OF THE POSTMARKET RISK IDENTI-
FICATION AND ANALYSIS SYSTEM.— 
‘‘(i) IN GENERAL.—The Secretary shall, not later 
than 1 year after the development of the risk identifica-
tion and analysis methods under subparagraph (B), 
establish and maintain procedures—
H. R. 3580—123 
‘‘(I) for risk identification and analysis based 
on electronic health data, in compliance with the 
regulations promulgated under section 264(c) of 
the Health Insurance Portability and Account-
ability Act of 1996, and in a manner that does 
not 
disclose 
individually 
identifiable 
health 
information in violation of paragraph (4)(B); 
‘‘(II) for the reporting (in a standardized form) 
of data on all serious adverse drug experiences 
(as defined in section 505–1(b)) submitted to the 
Secretary under paragraph (1), and those adverse 
events submitted by patients, providers, and drug 
sponsors, when appropriate; 
‘‘(III) to provide for active adverse event 
surveillance using the following data sources, as 
available: 
‘‘(aa) Federal health-related electronic 
data (such as data from the Medicare program 
and the health systems of the Department 
of Veterans Affairs); 
‘‘(bb) private sector health-related elec-
tronic data (such as pharmaceutical purchase 
data and health insurance claims data); and 
‘‘(cc) other data as the Secretary deems 
necessary to create a robust system to identify 
adverse events and potential drug safety sig-
nals; 
‘‘(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 Secretary deter-
mines appropriate, which may include data on 
comparative national adverse event trends; and 
‘‘(VI) to enable the program to export data 
in a form appropriate for further aggregation, 
statistical analysis, 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 consider-
ation the need for data completeness, coding, cleansing, 
and standardized analysis and transmission. 
‘‘(iii) PRIVATE SECTOR RESOURCES.—To ensure the 
establishment of the active postmarket risk identifica-
tion and analysis system under this subsection not 
later than 1 year after the development of the risk 
identification and analysis methods under subpara-
graph (B), as required under clause (i), the Secretary 
may, on a temporary or permanent basis, implement 
systems or products developed by private entities. 
‘‘(iv) COMPLEMENTARY APPROACHES.—To the extent 
the active postmarket risk identification and analysis 
system under this subsection is not sufficient to gather 
data and information relevant to a priority drug safety 
question, the Secretary shall develop, support, and
H. R. 3580—124 
participate in complementary approaches to gather and 
analyze such data and information, including— 
‘‘(I) approaches that are complementary with 
respect to assessing the safety of use of a drug 
in domestic populations not included, or underrep-
resented, in the trials used to approve the drug 
(such as older people, people with comorbidities, 
pregnant women, or children); and 
‘‘(II) existing approaches such as the Vaccine 
Adverse Event Reporting System and the Vaccine 
Safety Datalink or successor databases. 
‘‘(v) AUTHORITY
FOR
CONTRACTS.—The Secretary 
may enter into contracts with public and private enti-
ties to fulfill the requirements of this subparagraph. 
‘‘(4) ADVANCED ANALYSIS OF DRUG SAFETY DATA.— 
‘‘(A) PURPOSE.—The Secretary shall establish collabora-
tions with public, academic, and private entities, which 
may include the Centers for Education and Research on 
Therapeutics under section 912 of the Public Health Service 
Act, to provide for advanced analysis of drug safety data 
described in paragraph (3)(C) and other information that 
is publicly available or is provided by the Secretary, in 
order to— 
‘‘(i) 
improve 
the 
quality 
and 
efficiency 
of 
postmarket drug safety risk-benefit analysis; 
‘‘(ii) provide the Secretary with routine access to 
outside expertise to study advanced drug safety ques-
tions; and 
‘‘(iii) enhance the ability of the Secretary to make 
timely assessments based on drug safety data. 
‘‘(B) PRIVACY.—Such analysis shall not disclose individ-
ually identifiable health information when presenting such 
drug safety signals and trends or when responding to 
inquiries regarding such drug safety signals and trends. 
‘‘(C) PUBLIC
PROCESS
FOR
PRIORITY
QUESTIONS.—At 
least biannually, the Secretary shall seek recommendations 
from the Drug Safety and Risk Management Advisory Com-
mittee (or any successor committee) and from other 
advisory committees, as appropriate, to the Food and Drug 
Administration on— 
‘‘(i) priority drug safety questions; and 
‘‘(ii) mechanisms for answering such questions, 
including through— 
‘‘(I) active risk identification under paragraph 
(3); and 
‘‘(II) when such risk identification is not suffi-
cient, postapproval studies and clinical trials under 
subsection (o)(3). 
‘‘(D) PROCEDURES
FOR
THE
DEVELOPMENT
OF
DRUG 
SAFETY COLLABORATIONS.— 
‘‘(i) IN GENERAL.—Not later than 180 days after 
the date of the establishment of the active postmarket 
risk identification and analysis system under this sub-
section, the Secretary shall establish and implement 
procedures under which the Secretary may routinely 
contract with one or more qualified entities to—