291 
fails to comply with a requirement of such strategy pro-
vided 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 redesignated by section 
901(d)(4), 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 applicant (as such term is used in section 
505–1) who violates a requirement of section 505(o), sec-
tion 505(p), or section 505–1 shall be subject to a civil 
monetary penalty of— 
‘‘(A) 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 
‘‘(B) in the case of a violation that continues 
after the Secretary provides notice of such violation 
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292 
to the applicant, not more than $10,000,000 per vio-
lation, and not to exceed $50,000,000 for all such 
violations adjudicated in a single proceeding. 
If a violation referred to in subparagraph (A) or (B) is 
continuing in nature and poses a substantial threat to the 
public health, the Secretary may impose a civil penalty not 
to exceed $1,000,000 per day during such time period 
such person is in violation.’’; 
(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. 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-
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293 
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-
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 shall consider the possibility of includ-
ing in the labeling and any direct-to-consumer advertise-
ments of a newly approved drug or indication a unique 
symbol indicating the newly approved status of the drug 
or indication for a period after approval. 
SEC. 905. POSTMARKET RISK IDENTIFICATION AND ANAL-
YSIS SYSTEM FOR ACTIVE SURVEILLANCE 
AND ASSESSMENT. 
(a) FINDINGS.—Congress finds the following: 
(1) It is in the best interests of healthcare pro-
viders and patients that a postmarketing surveil-
lance system be developed that will enable active sur-
veillance of disparate sources of data to identify sig-
nals of unexpected adverse events and trends in the 
frequency of known adverse events, to provide data 
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on the outcomes of off label uses, and to enable 
identification of safety issues earlier than can be 
done today. 
(2) Such a system can best be developed 
through public private partnerships to develop meth-
ods and tools for conducting surveillance using elec-
tronic databases that currently contain data on mil-
lions of patient encounters and are expected to grow 
significantly in the next decade, as well as electronic 
databases that contain millions of medical product 
purchases, health care claims, and similar informa-
tion relevant to product use, efficacy, and safety. 
(3) Therefore, this section directs the Secretary 
of Health and Human Services to enter into such 
public private partnerships as are necessary to de-
velop such a surveillance system and the tools and 
methods necessary to conduct active surveillance 
using the system. 
(b) DEVELOPMENT
OF
THE
POSTMARKET
RISK 
IDENTIFICATION AND ANALYSIS SYSTEM.—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) The Secretary shall establish public private part-
nerships to develop tools and methods to enable the Sec-
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