H. R. 3580—125 
‘‘(I) classify, analyze, or aggregate data 
described in paragraph (3)(C) and information that 
is publicly available or is provided by the Sec-
retary; 
‘‘(II) allow for prompt investigation of priority 
drug safety questions, including— 
‘‘(aa) unresolved safety questions for drugs 
or classes of drugs; and 
‘‘(bb) for a newly-approved drugs, safety 
signals from clinical trials used to approve 
the drug and other preapproval trials; rare, 
serious drug side effects; and the safety of 
use in domestic populations not included, or 
underrepresented, in the trials used to approve 
the drug (such as older people, people with 
comorbidities, pregnant women, or children); 
‘‘(III) perform advanced research and analysis 
on identified drug safety risks; 
‘‘(IV) focus postapproval studies and clinical 
trials under subsection (o)(3) more effectively on 
cases for which reports under paragraph (1) and 
other safety signal detection is not sufficient to 
resolve whether there is an elevated risk of a 
serious adverse event associated with the use of 
a drug; and 
‘‘(V) carry out other activities as the Secretary 
deems necessary to carry out the purposes of this 
paragraph. 
‘‘(ii) REQUEST FOR SPECIFIC METHODOLOGY.—The 
procedures described in clause (i) shall permit the Sec-
retary to request that a specific methodology be used 
by the qualified entity. The qualified entity shall work 
with the Secretary to finalize the methodology to be 
used. 
‘‘(E) USE OF ANALYSES.—The Secretary shall provide 
the analyses described in this paragraph, including the 
methods and results of such analyses, about a drug to 
the sponsor or sponsors of such drug. 
‘‘(F) QUALIFIED ENTITIES.— 
‘‘(i) IN GENERAL.—The Secretary shall enter into 
contracts with a sufficient number of qualified entities 
to develop and provide information to the Secretary 
in a timely manner. 
‘‘(ii) QUALIFICATION.—The Secretary shall enter 
into a contract with an entity under clause (i) only 
if the Secretary determines that the entity has a 
significant presence in the United States and has one 
or more of the following qualifications: 
‘‘(I) The research, statistical, epidemiologic, or 
clinical capability and expertise to conduct and 
complete the activities under this paragraph, 
including the capability and expertise to provide 
the Secretary de-identified data consistent with 
the requirements of this subsection. 
‘‘(II) An information technology infrastructure 
in place to support electronic data and operational 
standards to provide security for such data.
H. R. 3580—126 
‘‘(III) Experience with, and expertise on, the 
development of drug safety and effectiveness 
research using electronic population data. 
‘‘(IV) An understanding of drug development 
or risk/benefit balancing in a clinical setting. 
‘‘(V) Other expertise which the Secretary 
deems necessary to fulfill the activities under this 
paragraph. 
‘‘(G) CONTRACT REQUIREMENTS.—Each contract with a 
qualified entity under subparagraph (F)(i) shall contain 
the following requirements: 
‘‘(i) ENSURING PRIVACY.—The qualified entity shall 
ensure that the entity will not use data under this 
subsection in a manner that— 
‘‘(I) violates the regulations promulgated under 
section 264(c) of the Health Insurance Portability 
and Accountability Act of 1996; 
‘‘(II) violates sections 552 or 552a of title 5, 
United States Code, with regard to the privacy 
of 
individually-identifiable 
beneficiary 
health 
information; or 
‘‘(III) discloses individually identifiable health 
information when presenting drug safety signals 
and trends or when responding to inquiries 
regarding drug safety signals and trends. 
Nothing in this clause prohibits lawful disclosure for 
other purposes. 
‘‘(ii) COMPONENT OF ANOTHER ORGANIZATION.—If 
a qualified entity is a component of another organiza-
tion— 
‘‘(I) the qualified entity shall establish appro-
priate security measures to maintain the confiden-
tiality and privacy of such data; and 
‘‘(II) the entity shall not make an unauthorized 
disclosure of such data to the other components 
of the organization in breach of such confidentiality 
and privacy requirement. 
‘‘(iii) TERMINATION OR NONRENEWAL.—If a contract 
with a qualified entity under this subparagraph is 
terminated or not renewed, the following requirements 
shall apply: 
‘‘(I) CONFIDENTIALITY
AND
PRIVACY
PROTEC-
TIONS.—The entity shall continue to comply with 
the confidentiality and privacy requirements under 
this paragraph with respect to all data disclosed 
to the entity. 
‘‘(II) DISPOSITION OF DATA.—The entity shall 
return any data disclosed to such entity under 
this subsection to which it would not otherwise 
have access or, if returning the data is not prac-
ticable, destroy the data. 
‘‘(H) COMPETITIVE PROCEDURES.—The Secretary shall 
use competitive procedures (as defined in section 4(5) of 
the Federal Procurement 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
H. R. 3580—127 
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 appropriate communications 
to the public, scientific, public health, and medical commu-
nities, and other key stakeholders, and to the extent prac-
ticable shall coordinate with the activities of private enti-
ties, professional associations, or other entities that may 
have sources of drug safety data.’’. 
(b) RULE OF CONSTRUCTION.—Nothing in this section or the 
amendment made by this section shall be construed to prohibit 
the lawful disclosure or use of data or information by an entity 
other than as described in paragraph (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 Secretary 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 Cosmetic 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. 379h), there are authorized to be appro-
priated to carry out the amendment made by this section, in addi-
tion 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 
described in paragraphs (3) and (4) of section 505(k) of the Federal 
Food, Drug, and Cosmetic Act, as added by subsection (a), and 
make recommendations to the Committee on Energy and Commerce 
of the House of Representatives and the Committee on Health, 
Education, Labor and Pensions of the Senate, and any other 
congressional committees of relevant jurisdiction, regarding the 
need for any additional legislative or regulatory actions to ensure 
privacy, confidentiality, and security of this data or otherwise 
address privacy, confidentiality, and security issues to ensure the 
effective operation of such active postmarket identification and anal-
ysis system. 
SEC. 906. STATEMENT FOR INCLUSION IN DIRECT-TO-CONSUMER 
ADVERTISEMENTS OF DRUGS. 
(a) PUBLISHED DIRECT-TO-CONSUMER ADVERTISEMENTS.—Sec-
tion 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
H. R. 3580—128 
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-consumer tele-
vision 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 the information in the 
statement described in paragraph (1) would detract from the 
presentation of risk information in a direct-to-consumer tele-
vision advertisement. If such Secretary determines the inclusion 
of such statement is appropriate in direct-to-consumer tele-
vision 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 appropriate 
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 subtitle, shall 
have no effect on the use of drugs approved under section 505 
of the Federal Food, Drug, and Cosmetic Act by, or on the lawful 
written or oral order of, a licensed veterinarian within the context 
of a veterinarian-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 amend-
ments made by this subtitle, there is authorized to be appropriated 
$25,000,000 for each of fiscal years 2008 through 2012. 
(b) RELATION TO OTHER FUNDING.—The authorization of appro-
priations 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 approved risk evaluation and 
mitigation strategy under section 505–1 of the Federal Food, 
Drug, and Cosmetic 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 section 601.42 
of title 21, Code of Federal Regulations; or