331 
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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this paragraph with respect to all data 
disclosed to the entity. 
‘‘(II) DISPOSITION
OF
DATA.— 
The entity shall return any data dis-
closed to such entity under this sub-
section to which it would not other-
wise have access or, if returning the 
data is not practicable, destroy the 
data. 
‘‘(H) COMPETITIVE
PROCEDURES.—The 
Secretary shall use competitive procedures (as 
defined in section 4(5) of the Federal Procure-
ment Policy Act) to enter into contracts under 
subparagraph (G). 
‘‘(I) REVIEW OF CONTRACT IN THE EVENT 
OF A MERGER OR ACQUISITION.—The Secretary 
shall review the contract with a qualified entity 
under this paragraph in the event of a merger 
or acquisition of the entity in order to ensure 
that the requirements under this paragraph will 
continue to be met. 
‘‘(J) COORDINATION.—In carrying out this 
paragraph, the Secretary shall provide for ap-
propriate communications to the public, sci-
entific, public health, and medical communities, 
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346 
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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348 
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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351 
(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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353 
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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355 
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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