284 
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) 
is amended— 
(A) by redesignating subsection (g) (relat-
ing to civil penalties) as subsection (f); and 
(B) 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 
Health Service Act, any such person who disseminates a 
direct-to-consumer advertisement that is false or mis-
leading shall be liable to the United States for a civil pen-
alty in an amount not to exceed $250,000 for the first 
such violation in any 3-year period, and not to exceed 
$500,000 for each subsequent violation in any 3-year pe-
riod. No other civil monetary penalties in this Act (includ-
ing the civil penalty in section 303(f)(3)) shall apply to 
a violation regarding direct-to-consumer advertising. For 
purposes of this paragraph: (A) Repeated dissemination 
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285 
of the same or similar advertisement prior to the receipt 
of the written notice referred to in paragraph (2) for such 
advertisements shall be considered one violation. (B) On 
and after the date of the receipt of such a notice, all viola-
tions under this paragraph occurring in a single day shall 
be considered one violation 
‘‘(2) A civil penalty under paragraph (1) shall be as-
sessed by the Secretary by an order made on the record 
after providing written notice to the person to be assessed 
a civil penalty and an opportunity for a hearing in accord-
ance with this paragraph and section 554 of title 5, United 
States Code. If upon receipt of the written notice, the per-
son to be assessed a civil penalty objects and requests a 
hearing, then in the course of any investigation related 
to such hearing, the Secretary may issue subpoenas re-
quiring the attendance and testimony of witnesses and the 
production of evidence that relates to the matter under 
investigation, including information pertaining to the fac-
tors described in paragraph (3). 
‘‘(3) Upon the request of the person to be assessed 
a civil penalty under paragraph (1), the Secretary, in de-
termining the amount of the civil penalty, shall take into 
account the nature, circumstances, extent, and gravity of 
the violation or violations, including the following factors: 
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286 
‘‘(A) Whether the person submitted the adver-
tisement or a similar advertisement for review under 
section 736A. 
‘‘(B) Whether the person submitted the adver-
tisement for review if required under section 503B. 
‘‘(C) Whether, after submission of the adver-
tisement as described in subparagraph (A) or (B), 
the person disseminated the advertisement before 
the end of the 45-day comment period. 
‘‘(D) Whether the person incorporated any com-
ments made by the Secretary with regard to the ad-
vertisement into the advertisement prior to its dis-
semination. 
‘‘(E) Whether the person ceased distribution of 
the advertisement upon receipt of the written notice 
referred to in paragraph (2) for such advertisement. 
‘‘(F) Whether the person had the advertisement 
reviewed by qualified medical, regulatory, and legal 
reviewers prior to its dissemination. 
‘‘(G) Whether the violations were material. 
‘‘(H) Whether the person who created the ad-
vertisement acted in good faith. 
‘‘(I) Whether the person who created the adver-
tisement has been assessed a civil penalty under this 
provision within the previous 1-year period. 
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‘‘(J) The scope and extent of any voluntary, 
subsequent remedial action by the person. 
‘‘(K) Such other matters, as justice may re-
quire. 
‘‘(4)(A) Subject to subparagraph (B), no person shall 
be required to pay a civil penalty under paragraph (1) if 
the person submitted the advertisement to the Secretary 
and disseminated such advertisement after incorporating 
any comment received from the Secretary other than a 
recommendation subject to subsection 503B(c). 
‘‘(B) The Secretary may retract or modify any prior 
comments the Secretary has provided to an advertisement 
submitted to the Secretary based on new information or 
changed circumstances, so long as the Secretary provides 
written notice to the person of the new views of the Sec-
retary on the advertisement and provides a reasonable 
time for modification or correction of the advertisement 
prior to seeking any civil penalty under paragraph (1). 
‘‘(5) The Secretary may compromise, modify, or 
remit, with or without conditions, any civil penalty which 
may be assessed under paragraph (1). The amount of such 
penalty, when finally determined, or the amount charged 
upon in compromise, may be deducted from any sums 
owed by the United States to the person charged. 
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288 
‘‘(6) Any person who requested, in accordance with 
paragraph (2), a hearing with respect to the assessment 
of a civil penalty and who is aggrieved by an order assess-
ing a civil penalty, may file a petition for de novo judicial 
review of such order with the United States Court of Ap-
peals for the District of Columbia Circuit or for any other 
circuit in which such person resides or transacts business. 
Such a petition may only be filed within the 60-day period 
beginning on the date the order making such assessments 
was issued. 
‘‘(7) On an annual basis, the Secretary shall report 
to the Congress on direct-to-consumer advertising and its 
ability to communicate to subsets of the general popu-
lation, including elderly populations, children, and racial 
and ethnic minority communities. The Secretary shall es-
tablish a permanent advisory committee to advise the Sec-
retary with respect to such report. The membership of the 
advisory committee shall consist of nationally recognized 
medical, advertising, and communications experts, includ-
ing experts representing subsets of the general population. 
The members of the advisory committee shall serve with-
out pay, but may receive travel expenses, including per 
diem in lieu of subsistence in accordance with applicable 
provisions under subchapter I of chapter 57 of title 5, 
United States Code. The advisory committee shall study 
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289 
direct-to-consumer advertising as it relates to increased 
access to health information and decreased health dispari-
ties for these populations. The annual report required by 
this paragraph shall recommend effective ways to present 
and disseminate information to these populations. Such 
report shall also make recommendations regarding impedi-
ments 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 approaches for increasing the in-
clusion of such subsets of the general population. The Sec-
retary shall submit the first annual report under this para-
graph to the Committee on Health, Education, Labor, and 
Pensions of the Senate and the Committee on Energy and 
Commerce of the House of Representatives not later than 
18 months after the advisory committee has been con-
vened by the Secretary. 
‘‘(8) 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 
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‘‘(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.’’. 
(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 person responsible for complying with the strategy 
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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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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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