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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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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