H. R. 3580—117 
(c) REGULATION OF BIOLOGICAL PRODUCTS.—Section 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) POSTMARKET STUDIES AND CLINICAL TRIALS; LABELING; 
RISK EVALUATION AND MITIGATION STRATEGY.—A person that sub-
mits an application for a license under this paragraph is subject 
to sections 505(o), 505(p), and 505–1 of the Federal Food, Drug, 
and Cosmetic Act.’’; and 
(2) in subsection (j), by inserting ‘‘, including the require-
ments under sections 505(o), 505(p), and 505–1 of such Act,’’ 
after ‘‘, and Cosmetic Act’’. 
(d) ADVERTISEMENTS OF DRUGS.—The Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 301 et seq.), as amended by section 801(b), 
is amended— 
(1) in section 301 (21 U.S.C. 331), by adding at the end 
the following: 
‘‘(kk) The dissemination of a television advertisement without 
complying with section 503B.’’; and 
(2) by inserting after section 503A the following: 
‘‘SEC. 503B. PREREVIEW OF TELEVISION ADVERTISEMENTS. 
‘‘(a) IN GENERAL.—The Secretary may require the submission 
of any television advertisement for a drug (including 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 advertise-
ment. 
‘‘(b) REVIEW.—In conducting a review of a television advertise-
ment under this section, the Secretary may make recommendations 
with respect to information included in the label of the drug— 
‘‘(1) on changes that are— 
‘‘(A) necessary to protect the consumer good and well- 
being; or 
‘‘(B) consistent with prescribing information for the 
product under review; and 
‘‘(2) if appropriate and if information exists, on statements 
for inclusion in the advertisement to address the specific effi-
cacy of the drug as it relates to specific population groups, 
including elderly populations, children, and racial and ethnic 
minorities. 
‘‘(c) NO AUTHORITY TO REQUIRE CHANGES.—Except as provided 
by subsection (e), 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 ETH-
NICALLY DIVERSE COMMUNITIES.—In formulating recommendations 
under subsection (b), the Secretary shall take into consideration 
the impact of the advertised 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 without a specific disclosure about a serious 
risk listed in the labeling of the drug involved, the Secretary 
may require inclusion of such disclosure in the advertisement.
H. R. 3580—118 
‘‘(2) DATE OF APPROVAL.—In conducting a review of a tele-
vision advertisement under this section, the Secretary may 
require the advertisement to include, for a period not to exceed 
2 years from the date of the approval of the drug under section 
505 or section 351 of the Public Health Service Act, 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 section may be 
construed as having any effect on requirements under section 502(n) 
or on the authority of the Secretary under section 314.550, 314.640, 
601.45, or 601.94 of title 21, Code of Federal Regulations (or suc-
cessor 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 
advertisement for a drug subject to section 503(b)(1) pre-
sented 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 contra-
indications shall be presented in a clear, conspicuous, and 
neutral manner.’’. 
(B) REGULATIONS TO DETERMINE CLEAR, CONSPICUOUS, 
AND NEUTRAL MANNER.—Not later than 30 months after 
the date of the enactment of the Food and Drug Administra-
tion Amendments Act of 2007, the Secretary of Health 
and Human Services shall by regulation establish stand-
ards 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 Cosmetic 
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 Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 333), as amended by section 
801(b), is amended 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 subject to section 503(b) 
or under section 351 of the Public Health Service Act, any such 
person who disseminates or causes another party to disseminate 
a direct-to-consumer advertisement that is false or misleading shall 
be liable to the United States for a civil penalty 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 period. No other civil monetary penalties in this 
Act (including the civil penalty in section 303(f)(4)) shall apply 
to a violation regarding direct-to-consumer advertising. For pur-
poses 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 consid-
ered one violation. (B) On and after the date of the receipt of 
such a notice, all violations under this paragraph occurring in 
a single day shall be considered one violation. With respect to 
advertisements that appear in magazines or other publications that 
are published less frequently than daily, each issue date (whether 
weekly or monthly) shall be treated as a single day for the purpose 
of calculating the number of violations under this paragraph.
H. R. 3580—119 
‘‘(2) A civil penalty under paragraph (1) shall be assessed 
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 accordance with this paragraph 
and section 554 of title 5, United States Code. If upon receipt 
of the written notice, the person to be assessed a civil penalty 
objects and requests a hearing, then in the course of any investiga-
tion related to such hearing, the Secretary may issue subpoenas 
requiring the attendance and testimony of witnesses and the produc-
tion of evidence that relates to the matter under investigation, 
including information pertaining to the factors described in para-
graph (3). 
‘‘(3) The Secretary, in determining the amount of the civil 
penalty under paragraph (1), 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 advertisement or 
a similar advertisement for review under section 736A. 
‘‘(B) Whether the person submitted the advertisement for 
review if required under section 503B. 
‘‘(C) Whether, after submission of the advertisement as 
described in subparagraph (A) or (B), the person disseminated 
or caused another party to disseminate the advertisement 
before the end of the 45-day comment period. 
‘‘(D) Whether the person incorporated any comments made 
by the Secretary with regard to the advertisement into the 
advertisement prior to its dissemination. 
‘‘(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 advertisement 
or caused the advertisement to be created acted in good faith. 
‘‘(I) Whether the person who created the advertisement 
or caused the advertisement to be created 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 require. 
‘‘(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 or caused 
another party to disseminate such advertisement after incorporating 
each comment received from the Secretary. 
‘‘(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 Secretary 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
H. R. 3580—120 
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 assessing a civil penalty, may 
file a petition for de novo judicial review of such order with the 
United States Court of Appeals 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) If any person fails to pay an assessment of a civil penalty 
under paragraph (1)— 
‘‘(A) after the order making the assessment becomes final, 
and if such person does not file a petition 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 judgment, 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.’’. 
(5) REPORT
ON
DIRECT-TO-CONSUMER
ADVERTISING.—Not 
later than 24 months after the date of the enactment of this 
Act, the Secretary of Health and Human Services shall report 
to the Congress on direct-to-consumer advertising and its ability 
to communicate to subsets of the general population, including 
elderly populations, children, and racial and ethnic minority 
communities. The Secretary shall utilize the Advisory Com-
mittee on Risk Communication established under this Act to 
advise the Secretary with respect to such report. The Advisory 
Committee shall study direct-to-consumer advertising as it 
relates to increased access to health information and decreased 
health disparities for these populations. The report required 
by this paragraph shall recommend effective ways to present 
and disseminate information to these populations. Such report 
shall also make recommendations regarding impediments 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 inclusion of such subsets 
of the general population. The Secretary of Health and Human 
Services shall submit the report under this paragraph to the 
Committee on Health, Education, Labor, and Pensions of the 
Senate and the Committee on Energy and Commerce of the 
House of Representatives. 
(6) RULEMAKING.—Section 502(n) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 352(n)) is amended by 
striking ‘‘the procedure specified in section 701(e) of this Act’’ 
and inserting ‘‘section 701(a)’’. 
(e) RULE OF CONSTRUCTION REGARDING PEDIATRIC STUDIES.— 
This title and the amendments made by this title may not be