289 
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 
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-
290 
tion for judicial review of the order in accordance 
with paragraph (6), or 
‘‘(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:
291 
‘‘(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 
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—
292 
‘‘(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 
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)’’.
293 
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-
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.