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‘‘(5) NO EFFECT ON LABELING CHANGES THAT 
DO NOT REQUIRE PREAPPROVAL.—In the case of a 
labeling change to which section 314.70 of title 21, 
Code of Federal Regulations (or any successor regu-
lation), applies for which the submission of a supple-
mental application is not required or for which dis-
tribution of the drug involved may commence upon 
the receipt by the Secretary of a supplemental appli-
cation for the change, the submission of an assess-
ment of the approved risk evaluation and mitigation 
strategy for the drug under paragraph (2) is not re-
quired. 
‘‘(h) REVIEW OF PROPOSED STRATEGIES; REVIEW 
OF ASSESSMENTS OF APPROVED STRATEGIES.— 
‘‘(1) 
IN
GENERAL.—The 
Secretary 
shall 
promptly review each proposed risk evaluation and 
mitigation strategy for a drug submitted under sub-
section (a) and each assessment of an approved risk 
evaluation and mitigation strategy for a drug sub-
mitted under subsection (g). 
‘‘(2) MARKETING PLAN.— 
‘‘(A) IN GENERAL.—As part of a review 
conducted under this subsection, the Secretary 
may require the applicant to submit informa-
tion regarding its marketing plan and practices 
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for the drug, so as to allow the Secretary to de-
termine whether any of the proposed or ongoing 
marketing activities undermine any of the re-
quirements of the risk evaluation and mitiga-
tion strategy. 
‘‘(B) RULE OF CONSTRUCTION.—Subpara-
graph (A) may not be construed as authorizing 
the Secretary to make or direct any change in 
the marketing plan or practices involved. The 
preceding sentence does not affect any author-
ity of the Secretary under this Act, other than 
the authority of the Secretary under subpara-
graph (A). 
‘‘(3) DISCUSSION.—The Secretary shall initiate 
discussions with a responsible person for purposes of 
this subsection to determine a strategy— 
‘‘(A) if the proposed strategy is submitted 
as part of an application or supplemental appli-
cation under subsection (a) or subsection 
(g)(2)(A), not less than 60 days before the ac-
tion deadline for the application that has been 
agreed to by the Secretary and that has been 
set forth in goals identified in letters of the 
Secretary (relating to the use of fees collected 
under section 736 to expedite the drug develop-
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ment process and the process for the review of 
human drug applications); 
‘‘(B) if the assessment is submitted under 
subparagraph (B) or (C) or subsection (g)(2), 
not later than 20 days after such submission; 
‘‘(C) if the assessment is submitted under 
subsection (g)(1) or subsection (g)(2)(D) , not 
later than 30 days after such submission; or 
‘‘(D) if the assessment is submitted under 
subsection (g)(2)(D), not later than 10 days 
after such submission. 
‘‘(4) ACTION.— 
‘‘(A) IN GENERAL.—Unless the responsible 
person requests the dispute resolution process 
described under paragraph (5), the Secretary 
shall approve and describe the risk evaluation 
and mitigation strategy for a drug, or any 
modification to the strategy— 
‘‘(i) as part of the action letter on the 
application, when a proposed strategy is 
submitted under subsection (a) or an as-
sessment of the strategy is submitted 
under subsection (g)(1); or 
‘‘(ii) in an order issued not later than 
50 days after the date discussions of such 
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modification begin under paragraph (3), 
when an assessment of the strategy is sub-
mitted under subsection (g)(1) or under 
any of subparagraphs (B) through (D) of 
subsection (g)(2). 
‘‘(B) INACTION.—An approved risk evalua-
tion and mitigation strategy shall remain in ef-
fect until the Secretary acts, if the Secretary 
fails to act as provided under subparagraph 
(A). 
‘‘(C) PUBLIC
AVAILABILITY.—Any action 
letter described in subparagraph (A)(i) or order 
described in subparagraph (A)(ii) shall be made 
publicly available. 
‘‘(5) DISPUTE RESOLUTION.— 
‘‘(A) REQUEST FOR REVIEW.— 
‘‘(i) IN GENERAL.—Not earlier than 
15 days, and not later than 35 days, after 
discussions under paragraph (3) have 
begun, the responsible person may request 
in writing that a dispute about the strat-
egy be reviewed by the Drug Safety Over-
sight Board under subsection (j), except 
that the determination of the Secretary to 
require a risk evaluation and mitigation 
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strategy is not subject to review under this 
paragraph. The preceding sentence does 
not prohibit review under this paragraph of 
the particular elements of such a strategy. 
‘‘(ii) SCHEDULING.—Upon receipt of 
a request under clause (i), the Secretary 
shall schedule the dispute involved for re-
view under subparagraph (B) and, not 
later than 5 business days of scheduling 
the dispute for review, shall publish by 
posting on the Internet or otherwise a no-
tice that the dispute will be reviewed by 
the Drug Safety Oversight Board. 
‘‘(B) SCHEDULING REVIEW.—If a respon-
sible person requests review under subpara-
graph (A), the Secretary— 
‘‘(i) shall schedule the dispute for re-
view at 1 of the next 2 regular meetings of 
the Drug Safety Oversight Board, which-
ever meeting date is more practicable; or 
‘‘(ii) may convene a special meeting of 
the Drug Safety Oversight Board to review 
the matter more promptly, including to 
meet an action deadline on an application 
(including a supplemental application). 
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‘‘(C) AGREEMENT AFTER DISCUSSION OR 
ADMINISTRATIVE APPEALS.— 
‘‘(i) FURTHER DISCUSSION OR ADMIN-
ISTRATIVE APPEALS.—A request for review 
under subparagraph (A) shall not preclude 
further discussions to reach agreement on 
the risk evaluation and mitigation strategy, 
and such a request shall not preclude the 
use of administrative appeals within the 
Food and Drug Administration to reach 
agreement on the strategy, including ap-
peals as described in letters of the Sec-
retary (relating to the use of fees collected 
under section 736 to expedite the drug de-
velopment process and the process for the 
review of human drug applications) for 
procedural or scientific matters involving 
the review of human drug applications and 
supplemental applications that cannot be 
resolved at the divisional level. 
‘‘(ii) AGREEMENT
TERMINATES
DIS-
PUTE RESOLUTION.—At any time before a 
decision and order is issued under sub-
paragraph (G) , the Secretary and the re-
sponsible person may reach an agreement 
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on the risk evaluation and mitigation strat-
egy through further discussion or adminis-
trative appeals, terminating the dispute 
resolution process, and the Secretary shall 
issue an action letter or order, as appro-
priate, that describes the strategy. 
‘‘(D) MEETING
OF
THE
BOARD.—At a 
meeting of the Drug Safety Oversight Board 
described in subparagraph (B), the Board 
shall— 
‘‘(i) hear from both parties; and 
‘‘(ii) review the dispute. 
‘‘(E) RECORD
OF
PROCEEDINGS.—The 
Secretary shall ensure that the proceedings of 
any such meeting are recorded, transcribed, and 
made public within 30 days of the meeting. The 
Secretary shall redact the transcript to protect 
any trade secrets or other confidential informa-
tion described in section 552(b)(4) of title 5, 
United States Code. 
‘‘(F) 
RECOMMENDATION
OF
THE 
BOARD.—Not later than 5 days after any such 
meeting, the Drug Safety Oversight Board shall 
provide a written recommendation on resolving 
the dispute to the Secretary. Not later than 5 
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days after the Board provides such written rec-
ommendation to the Secretary, the Secretary 
shall make the recommendation available to the 
public. 
‘‘(G) ACTION BY THE SECRETARY.— 
‘‘(i) ACTION
LETTER.—With respect 
to a proposal or assessment referred to in 
paragraph (1), the Secretary shall issue an 
action letter that resolves the dispute not 
later than the later of— 
‘‘(I) the action deadline referred 
to in paragraph (3)(A); or 
‘‘(II) 7 days after receiving the 
recommendation of the Drug Safety 
Oversight Board. 
‘‘(ii) ORDER.—With respect to an as-
sessment of an approved risk evaluation 
and mitigation strategy under subsection 
(g)(1) or under any of subparagraphs (B) 
through (D) of subsection (g)(2), the Sec-
retary shall issue an order, which shall be 
made public, that resolves the dispute not 
later than 7 days after receiving the rec-
ommendation of the Drug Safety Oversight 
Board. 
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‘‘(H) INACTION.—An approved risk evalua-
tion and mitigation strategy shall remain in ef-
fect until the Secretary acts, if the Secretary 
fails to act as provided for under subparagraph 
(G). 
‘‘(I) EFFECT
ON
ACTION
DEADLINE.— 
With respect to a proposal or assessment re-
ferred to in paragraph (1), the Secretary shall 
be considered to have met the action deadline 
referred to in paragraph (3)(A) with respect to 
the application involved if the responsible per-
son requests the dispute resolution process de-
scribed in this paragraph and if the Secretary— 
‘‘(i) has initiated the discussions de-
scribed under paragraph (3) not less than 
60 days before such action deadline; and 
‘‘(ii) has complied with the timing re-
quirements of scheduling review by the 
Drug Safety Oversight Board, providing a 
written recommendation, and issuing an 
action letter under subparagraphs (B), 
(F), and (G), respectively. 
‘‘(J) DISQUALIFICATION.—No individual 
who is an employee of the Food and Drug Ad-
ministration and who reviews a drug or who 
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participated in an administrative appeal under 
subparagraph (C)(i) with respect to such drug 
may serve on the Drug Safety Oversight Board 
at a meeting under subparagraph (D) to review 
a dispute about the risk evaluation and mitiga-
tion strategy for such drug. 
‘‘(K) ADDITIONAL EXPERTISE.—The Drug 
Safety Oversight Board may add members with 
relevant expertise from the Food and Drug Ad-
ministration, including the Office of Pediatrics, 
the Office of Women’s Health, or the Office of 
Rare Diseases, or from other Federal public 
health or health care agencies, for a meeting 
under subparagraph (D) of the Drug Safety 
Oversight Board. 
‘‘(6) USE
OF
ADVISORY
COMMITTEES.—The 
Secretary may convene a meeting of 1 or more advi-
sory committees of the Food and Drug Administra-
tion to— 
‘‘(A) review a concern about the safety of 
a drug or class of drugs, including before an as-
sessment of the risk evaluation and mitigation 
strategy or strategies of such drug or drugs is 
required to be submitted under any of subpara-
graphs (B) through (D) of subsection (g)(2); 
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‘‘(B) review the risk evaluation and mitiga-
tion strategy or strategies of a drug or group 
of drugs; or 
‘‘(C) review a dispute under paragraph (5). 
‘‘(7) PROCESS FOR ADDRESSING DRUG CLASS 
EFFECTS.— 
‘‘(A) IN GENERAL.—When a concern about 
a serious risk of a drug may be related to the 
pharmacological class of the drug, the Secretary 
may defer assessments of the approved risk 
evaluation and mitigation strategies for such 
drugs until the Secretary has convened 1 or 
more public meetings to consider possible re-
sponses to such concern. If the Secretary defers 
an assessment under this subparagraph, the 
Secretary shall give notice to the public of the 
deferral not later than 5 days of the deferral. 
‘‘(B) PUBLIC
MEETINGS.—Such public 
meetings may include— 
‘‘(i) 1 or more meetings of the re-
viewed entities for such drugs; 
‘‘(ii) 1 or more meetings of 1 or more 
advisory committees of the Food and Drug 
Administration, as provided for under 
paragraph (6); or 
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‘‘(iii) 1 or more workshops of sci-
entific experts and other stakeholders. 
‘‘(C) ACTION.—After considering the dis-
cussions from any meetings under subpara-
graph (B), the Secretary may— 
‘‘(i) announce in the Federal Register 
a planned regulatory action, including a 
modification to each risk evaluation and 
mitigation strategy, for drugs in the phar-
macological class; 
‘‘(ii) seek public comment about such 
action; and 
‘‘(iii) after seeking such comment, 
issue an order addressing such regulatory 
action. 
‘‘(8) 
INTERNATIONAL
COORDINATION.—The 
Secretary may coordinate the timetable for submis-
sion of assessments under subsection (d), or a study 
or clinical trial under section 505(o)(3), with efforts 
to identify and assess the serious risks of such drug 
by the marketing authorities of other countries 
whose drug approval and risk management processes 
the Secretary deems comparable to the drug ap-
proval and risk management processes of the United 
States. If the Secretary takes action to coordinate 
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such timetable, the Secretary shall give notice to the 
public of the action not later than 5 days after the 
action. 
‘‘(9) EFFECT.—Use of the processes described 
in paragraphs (7) and (8) shall not delay action on 
an application or a supplement to an application for 
a drug. 
‘‘(i) ABBREVIATED NEW DRUG APPLICATIONS.— 
‘‘(1) IN GENERAL.—A drug that is the subject 
of an abbreviated new drug application under section 
505(j) is subject to only the following elements of 
the risk evaluation and mitigation strategy required 
under subsection (a) for the applicable listed drug: 
‘‘(A) A Medication Guide or patient pack-
age insert, if required under subsection (e) for 
the applicable listed drug. 
‘‘(B) Restrictions on distribution or use, if 
required under subsection (f) for the listed 
drug. A drug that is the subject of an abbre-
viated new drug application and the listed drug 
shall use a single, shared system under sub-
section (f)(4). The Secretary may waive the re-
quirement under the preceding sentence for a 
drug that is the subject of an abbreviated new 
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drug application if the Secretary determines 
that— 
‘‘(i) it is not practical for the drug to 
use such single, shared system; or 
‘‘(ii) the burden of using the single, 
shared system outweighs the benefit of 
using the single system. 
‘‘(2) ACTION BY SECRETARY.—For an applica-
ble listed drug for which a drug is approved under 
section 505(j), the Secretary— 
‘‘(A) shall undertake any communication 
plan to health care providers required under 
subsection (e)(3) for the applicable listed drug; 
and 
‘‘(B) shall inform the responsible person 
for the drug that is so approved if the risk eval-
uation and mitigation strategy for the applica-
ble listed drug is modified. 
‘‘(j) DRUG SAFETY OVERSIGHT BOARD.— 
‘‘(1) IN
GENERAL.—There is established a 
Drug Safety Oversight Board. 
‘‘(2) COMPOSITION; 
MEETINGS.—The Drug 
Safety Oversight Board shall— 
‘‘(A) be composed of scientists and health 
care practitioners appointed by the Secretary, 
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each of whom is an employee of the Federal 
Government; 
‘‘(B) include representatives from offices 
throughout the Food and Drug Administration; 
‘‘(C) include at least 1 representative from 
each of the National Institutes of Health and 
the Department of Health and Human Services 
(other than the Food and Drug Administra-
tion); 
‘‘(D) include such representatives as the 
Secretary shall designate from other appro-
priate agencies that wish to provide representa-
tives; and 
‘‘(E) meet at least monthly to provide 
oversight and advice to the Secretary on the 
management of important drug safety issues.’’. 
(c) REGULATION OF BIOLOGICAL PRODUCTS.—Sec-
tion 351 of the Public Health Service Act (42 U.S.C. 262) 
is amended— 
(1) in subsection (a)(2), by adding at the end 
the following: 
‘‘(D) RISK EVALUATION AND MITIGATION STRAT-
EGY.—A person that submits an application for a license 
under this paragraph is subject to section 505(p) of the 
Federal Food, Drug, and Cosmetic Act.’’; and 
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(2) in subsection (j), by inserting ‘‘, including 
the requirements under section 505(p) of such Act,’’ 
after ‘‘, and Cosmetic Act’’. 
(d) PREREVIEW OF ADVERTISEMENTS.— 
(1) SENSE OF CONGRESS.—It is the sense of 
the Congress that— 
(A) ‘‘Guidance for Industry Consumer-Di-
rected Broadcast Advertisements’’ issued by the 
Food and Drug Administration in August, 
1999, represents generally good guidance for di-
rect-to-consumer (DTC) advertising of prescrip-
tion medicines and other treatments; 
(B) direct-to-consumer advertising as an 
accurate source of health information for all 
populations, specifically including the elderly 
populations, children, chronically ill and racial 
and ethnic minority populations, should be 
made more reliable by ensuring the truth and 
credibility of information provided through such 
advertising; and 
(C) the Congress will work with the Food 
and Drug Administration to ensure that infor-
mation provided through direct-to-consumer ad-
vertising of prescription medicines and other 
treatments is not false or misleading and com-
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municates clearly and sensitively to all commu-
nities. 
(2) PREREVIEW.—The Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 301 et seq.) is amend-
ed— 
(A) in section 301 (21 U.S.C. 331), by 
adding at the end the following: 
‘‘(jj) The dissemination of a television advertisement 
without complying with section 503B.’’; and 
(B) by inserting after section 503A the fol-
lowing: 
‘‘SEC. 503B. PREREVIEW OF TELEVISION ADVERTISEMENTS. 
‘‘(a) IN GENERAL.—The Secretary may require the 
submission of any television advertisement for a drug (in-
cluding any script, story board, rough, or a completed 
video production of the television advertisement) to the 
Secretary for review under this section not later than 45 
days before dissemination of the television advertisement. 
‘‘(b) REVIEW.—In conducting a review of a television 
advertisement under this section, the Secretary may make 
recommendations— 
‘‘(1) on changes that are— 
‘‘(A) necessary to protect the consumer 
good and well-being; or 
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‘‘(B) consistent with prescribing informa-
tion for the product under review; and 
‘‘(2) if appropriate and if information exists, on 
statements for inclusion in the advertisement to ad-
dress the specific efficacy of the drug as it relates 
to a specific population group, including elderly pop-
ulations, children, and racially and ethnically diverse 
populations. 
‘‘(c) NO AUTHORITY TO REQUIRE CHANGES.—This 
section does not authorize the Secretary to make or direct 
changes in any material submitted pursuant to subsection 
(a). 
‘‘(d) ELDERLY POPULATIONS, CHILDREN, RACIALLY 
AND ETHNICALLY DIVERSE COMMUNITIES.—In formu-
lating recommendations under subsection (b), the Sec-
retary shall take into consideration the impact of the ad-
vertised drug on elderly populations, children, and racially 
and ethnically diverse communities. 
‘‘(e) SPECIFIC DISCLOSURES.— 
‘‘(1) SERIOUS
RISK; SAFETY
PROTOCOL.—In 
conducting a review of a television advertisement 
under this section, if the Secretary determines that 
the advertisement would be false or misleading with-
out a specific disclosure about a serious risk listed 
in the labeling of the drug involved, the Secretary 
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may require inclusion of such disclosure in the ad-
vertisement. 
‘‘(2) DATE OF APPROVAL.—In conducting a re-
view of a television advertisement under this section, 
the Secretary may require the advertisement to in-
clude, for a period not to exceed 2 years from the 
date of the approval of the drug under section 505, 
a specific disclosure of such date of approval if the 
Secretary determines that the advertisement would 
otherwise be false or misleading. 
‘‘(f) RULE OF CONSTRUCTION.—Nothing in this sec-
tion may be construed as having any effect on the author-
ity of the Secretary under section 314.550, 314.640, 
601.45, or 601.94 of title 21, Code of Federal Regulations 
(or successor regulations).’’. 
(3) DIRECT-TO-CONSUMER ADVERTISEMENTS.— 
(A) IN GENERAL.—Section 502(n) of the 
Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 352(n)) is amended by adding at the 
end the following: ‘‘In the case of an advertise-
ment for a drug subject to section 503(b)(1) 
presented directly to consumers in television or 
radio format and stating the name of the drug 
and its conditions of use, the major statement 
relating to side effects and contraindications 
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shall be presented in a clear and conspicuous 
manner.’’. 
(B) REGULATIONS TO DETERMINE CLEAR 
AND CONSPICUOUS MANNER.—The Secretary of 
Health and Human Services shall by regulation 
establish standards for determining whether a 
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 
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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 
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). 
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‘‘(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: 
‘‘(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. 
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‘‘(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. 
‘‘(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 
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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. 
‘‘(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-
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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-
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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: 
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‘‘(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— 
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‘‘(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)’’. 
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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. 
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