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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‘‘(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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