I 
110TH CONGRESS 
2D SESSION 
H. R. 6151 
To amend the Federal Food, Drug, and Cosmetic Act with respect to drug 
and device advertising, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
MAY 22, 2008 
Ms. DELAURO (for herself and Mrs. EMERSON) introduced the following bill; 
which was referred to the Committee on Energy and Commerce 
A BILL 
To amend the Federal Food, Drug, and Cosmetic Act with 
respect to drug and device advertising, and for other 
purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Responsibility in Drug 
and Device Advertising Act of 2008’’. 
SEC. 2. DIRECT-TO-CONSUMER DRUG OR DEVICE ADVER-
TISING. 
(a) IN GENERAL.—The Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 301 et seq.) is amended— 
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(1) in section 301, by adding at the end the fol-
lowing: 
‘‘(oo) The conduct of direct-to-consumer advertising 
of a drug or device in violation of section 503C.’’; and 
(2) in chapter V, by inserting after section 
503B the following: 
‘‘SEC. 503C. DIRECT-TO-CONSUMER DRUG OR DEVICE AD-
VERTISING. 
‘‘(a) PROHIBITIONS.— 
‘‘(1) FIRST THREE YEARS.— 
‘‘(A) IN
GENERAL.—Subject to subpara-
graph (B), no person shall conduct direct-to- 
consumer advertising of— 
‘‘(i) a drug for which an application is 
submitted under section 505(b) before the 
end of the 3-year period beginning on the 
date of the approval of such application; or 
‘‘(ii) a class II or class III device for 
which a premarket notification is sub-
mitted under section 510(k) or a class III 
device for which a premarket approval is 
sought under section 515, before the end 
of the 3-year period beginning on the date 
of the notification or approval, respectively. 
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‘‘(B) WAIVER.—The Secretary may waive 
the application of subparagraph (A) to a drug 
or device during the third year of the 3-year pe-
riod described in such subparagraph if— 
‘‘(i) the sponsor of the drug or device 
submits an application to the Secretary 
pursuant to subparagraph (C); and 
‘‘(ii) the Secretary, after considering 
the application and any accompanying ma-
terials, determines that direct-to-consumer 
advertising of the drug or device would 
have an affirmative value to public health. 
‘‘(C) APPLICATION FOR WAIVER.—To seek 
a waiver under subparagraph (B), the sponsor 
of a drug or device shall submit an application 
to the Secretary at such time, in such manner, 
and containing such information as the Sec-
retary may require. 
‘‘(2) SUBSEQUENT YEARS.— 
‘‘(A) EXTENSION OF PROHIBITION.—The 
Secretary may prohibit direct-to-consumer ad-
vertising of a drug or a class II or class III de-
vice during the period beginning at the end of 
the 3-year period described in paragraph (1)(A) 
if the Secretary determines that the drug or de-
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vice has significant adverse health effects based 
on post-approval studies, risk-benefit analyses, 
adverse event reports, the scientific literature, 
any clinical or observational studies, or any 
other appropriate resource. 
‘‘(B) FAIR
BALANCE
OF
BENEFITS
AND 
RISKS
FOR
DRUGS
AND
DEVICES
FOR
PER-
MITTED DTC ADVERTISING.—Any direct-to-con-
sumer advertising of a drug or a class II or 
class III device permitted under this section 
shall include a fair balance, as supported by the 
evidence, of the benefits and the risks associ-
ated with the drug or device. 
‘‘(b) REGULATIONS.—Not later than 1 year after the 
date of the enactment of this section, the Secretary shall 
revise the regulations promulgated under this Act gov-
erning advertisements of drugs and devices to the extent 
necessary to implement this section. 
‘‘(c) RULE OF CONSTRUCTION.—This section shall 
not be construed to diminish the authority of the Secretary 
to prohibit or regulate direct-to-consumer advertising of 
drugs or devices under other provisions of law.’’. 
(b) EFFECTIVE DATE.—The amendments made by 
subsection (a) apply only with respect to a drug for which 
an application is approved under section 505(b) of the 
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Federal Food, Drug, and Cosmetic Act, a class II or class 
III device for which a notification is submitted under sec-
tion 510(k) of such Act, or a class III device for which 
an application is approved under section 515 of such Act, 
on or after the date that is 1 year before the date of the 
enactment of this Act. 
SEC. 3. PROMINENT DISPLAY OF INFORMATION IN ADVER-
TISING ON SIDE EFFECTS, CONTRAINDICA-
TIONS, AND EFFECTIVENESS. 
(a) REQUIREMENT FOR DRUGS.— 
(1) IN GENERAL.—Subparagraph (3) of section 
502(n) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 352(n)) is amended— 
(A) by striking ‘‘such other information’’ 
and all that follows through ‘‘which shall be 
issued by’’ and inserting ‘‘such other informa-
tion in brief summary relating to side effects, 
contraindications, and effectiveness as shall be 
required in regulations which shall require such 
information to be prominently displayed in 
terms of font size and location and shall be 
issued by’’; 
(B) by striking ‘‘in the case of published 
direct-to-consumer advertisements’’ and insert-
ing ‘‘in the case of direct-to-consumer advertise-
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ments (including an advertisement that accom-
panies video programming delivered by tele-
vision broadcasting or by a multichannel video 
programming distributor (as defined in section 
602 of the Communications Act of 1934))’’; 
and 
(C) by striking ‘‘published after the effec-
tive date’’ and inserting ‘‘disseminated after the 
effective date’’. 
(2) DISCONTINUANCE
OF
STUDY.—The Sec-
retary of Health and Human Services shall dis-
continue the study required by section 906(b) of the 
Food and Drug Administration Amendments Act of 
2007 (Public Law 110–85). 
(b) APPLICATION
OF SIMILAR RULES
FOR DE-
VICES.—The first sentence of section 502(r) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 352(r)) 
is amended— 
(1) by striking ‘‘(1) a true statement’’ and in-
serting ‘‘a true statement (1)’’; 
(2) by striking ‘‘a brief statement’’; and 
(3) by inserting before the period at the end the 
following: ‘‘, and in the case of direct-to-consumer 
advertisements (including an advertisement that ac-
companies video programming delivered by television 
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broadcasting or by a multichannel video program-
ming distributor (as defined in section 602 of the 
Communications Act of 1934)) the following state-
ment printed in conspicuous text: ‘You are encour-
aged to report negative side effects of medical de-
vices to the FDA. Visit www.fda.gov/medwatch, or 
call 1–800–FDA–1088.’ ’’. 
(c) EFFECTIVE DATE.—The amendments made by 
this section apply with respect to any advertisement or 
other descriptive printed matter that is issued or caused 
to be issued on or after the date that is 90 days after 
the date of the enactment of this Act. Not later than 90 
days after the date of the enactment of this Act, the Sec-
retary shall revise any regulations promulgated pursuant 
to subsections (n) and (r) of section 502 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 352) to the ex-
tent necessary to implement this section. 
SEC. 4. CIVIL PENALTY. 
Subsection (g) of section 303 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 333) is amended to 
read as follows: 
‘‘(g) DRUG
OR DEVICE ADVERTISING
AND PRO-
MOTION.— 
‘‘(1) CIVIL PENALTY.— 
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‘‘(A) IN
GENERAL.—Any manufacturer, 
packer, or distributor of a drug or device who 
violates section 505(n), section 503C, or any 
other requirement of this Act relating to the ad-
vertising or promotion of the drug or device 
shall be subject to a civil penalty in an amount 
not to exceed— 
‘‘(i) in the case of the first such viola-
tion by the manufacturer, packer, or dis-
tributor relating to the drug or device, 
$1,000,000; and 
‘‘(ii) in the case of each subsequent 
violation by the manufacturer, packer, or 
distributor relating to the drug or device, 
an amount that is twice the amount of the 
maximum civil penalty applicable under 
this subparagraph to the previous viola-
tion. 
‘‘(B) 
PROCEDURE.—Paragraphs 
(3) 
through (5) of subsection (f) shall apply with 
respect to a civil penalty under subparagraph 
(A) to the same extent and in the same manner 
as those paragraphs apply with respect to a 
civil penalty under paragraph (1), (2), (3), or 
(4) of subsection (f). 
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‘‘(2) DISTRIBUTION
OF
MATERIALS.—If the 
Secretary finds that a person committed a violation 
described in paragraph (1)(A), the Secretary may 
order the person to distribute materials in the same 
markets in which the violative advertisement or pro-
motional material was distributed in a manner de-
signed to notify the public and the medical commu-
nity of the violation and to provide corrective infor-
mation. 
‘‘(3) SEPARATE
OFFENSE.—For purposes of 
imposing a civil penalty under this subsection, each 
violation described in paragraph (1)(A), including 
each distribution of a direct-to-consumer advertise-
ment in violation of section 503C, shall constitute a 
separate offense. 
‘‘(4) RELATION TO OTHER PENALTIES.—A civil 
penalty under paragraph (1) and an order under 
paragraph (2) shall be in addition to any other pen-
alty applicable under this Act or other law to the 
violation involved.’’. 
SEC. 5. PUBLIC EDUCATION CAMPAIGN ON RISKS OF CER-
TAIN DRUGS AND DEVICES. 
The Secretary of Health and Human Services shall 
conduct an education campaign to increase public aware-
ness of risks that, for some patients, may outweigh the 
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benefits of using a particular drug or device, whether such 
risks are known at the time of the approval of the drug 
or device or become known after the approval of the drug 
or device. 
SEC. 6. ADDITIONAL FUNDING FOR REGULATION OF DI-
RECT-TO-CONSUMER DRUG AND DEVICE AD-
VERTISING. 
There are authorized to be appropriated to the Food 
and Drug Administration such sums as may be necessary 
for each of fiscal years 2009 and 2010 for the purpose 
of regulating direct-to-consumer drug and device adver-
tisements, including by carrying out the amendments 
made by section 2. The authorization of appropriations in 
the preceding sentence is in addition to any other author-
ization of appropriations for such purpose. 
Æ 
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