I 
109TH CONGRESS 
1ST SESSION H. R. 3950 
To amend the Federal Food, Drug, and Cosmetic Act with respect to drug 
advertising, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
SEPTEMBER 29, 2005 
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 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 
Advertising Act of 2005’’. 
SEC. 2. DIRECT-TO-CONSUMER DRUG ADVERTISING. 
The Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 301 et seq.) is amended— 
(1) in section 301, by adding at the end the fol-
lowing:
‘‘(hh) The conduct of direct-to-consumer advertising 
of a drug in violation of section 506D.’’; and 
(2) in chapter V, by inserting after section 
506C the following: 
‘‘SEC. 506D. DIRECT-TO-CONSUMER DRUG ADVERTISING. 
‘‘(a) PROHIBITIONS.— 
‘‘(1) FIRST THREE YEARS.— 
‘‘(A) IN
GENERAL.—Subject to subpara-
graph (B), no person shall conduct direct-to- 
consumer advertising of 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. 
‘‘(B) WAIVER.—The Secretary may waive 
the application of subparagraph (A) to a drug 
during the third year of the 3-year period de-
scribed in such subparagraph if— 
‘‘(i) the sponsor of the drug 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 would have an af-
firmative value to public health.
‘‘(C) APPLICATION FOR WAIVER.—To seek 
a waiver under subparagraph (B), the sponsor 
of a drug shall submit an application to the 
Secretary at such time, in such manner, and 
containing such information as the Secretary 
may require. 
‘‘(2) SUBSEQUENT YEARS.—The Secretary may 
prohibit direct-to-consumer advertising of a drug 
during the period beginning at the end of the 3-year 
period described in paragraph (1)(A) if the Sec-
retary determines that the drug has significant ad-
verse health effects based on post-approval studies, 
risk-benefit analyses, adverse event reports, the sci-
entific literature, any clinical or observational stud-
ies, or any other appropriate resource. 
‘‘(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 drug advertisements to the extent necessary to im-
plement 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 under other provisions of law.
‘‘(d) EFFECTIVE DATE.—This section applies only 
with respect to a drug for which an application submitted 
under section 505(b) is approved on or after the date that 
is 1 year before the date of the enactment of this section.’’. 
SEC. 3. PROMINENT DISPLAY OF INFORMATION IN ADVER-
TISING ON SIDE EFFECTS, CONTRAINDICA-
TIONS, AND EFFECTIVENESS. 
(a) REQUIREMENT.—Paragraph (3) of section 502(n) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
352(n)) is amended— 
(1) by redesignating subparagraphs (A) and 
(B) as clauses (i) and (ii); and 
(2) by striking ‘‘such other information’’ and all 
that follows through ‘‘which shall be issued by’’ and 
inserting ‘‘such other information in brief summary 
relating to side effects, contraindications, and effec-
tiveness as shall be required in regulations which (A) 
shall require such information to be prominently dis-
played in terms of font size and location and (B) 
shall be issued by’’. 
(b) EFFECTIVE DATE.—The amendment made by 
this section applies 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 enactment of this Act. Not later than such date, the
Secretary shall revise any regulations promulgated pursu-
ant to subsection (n) of section 503 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 352) to the extent 
necessary to implement this section. 
SEC. 4. CIVIL PENALTY. 
Section 303 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 333) is amended by adding at the end the 
following: 
‘‘(g) DRUG ADVERTISING AND PROMOTION.— 
‘‘(1) CIVIL PENALTY.— 
‘‘(A) IN
GENERAL.—Any manufacturer, 
packer, or distributor of a drug who violates 
section 505(n), section 506D, or any other re-
quirement of this Act relating to the advertising 
or promotion of the drug 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, $250,000; 
and 
‘‘(ii) in the case of each subsequent 
violation by the manufacturer, packer, or 
distributor relating to the drug, an amount 
that is twice the amount of the maximum
civil penalty applicable under this subpara-
graph to the previous violation. 
‘‘(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) or (2) of sub-
section (f). 
‘‘(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 506A, 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. ORDER REQUIRING POSTMARKET CHANGE IN LA-
BELING. 
The Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 301 et seq.) is amended— 
(1) in section 502, by adding at the end the fol-
lowing: 
‘‘(x) If it is a drug and its labeling fails to comply 
with an order issued pursuant to section 506E, or the 
manufacturer of the drug fails to provide notification to 
physicians as required by the Secretary pursuant to such 
section.’’; and 
(2) by inserting after section 506D, as added 
by section 2, the following: 
‘‘SEC. 506E. POSTMARKET CHANGE IN LABELING. 
‘‘(a) IN GENERAL.—In the case of any drug for 
which an approval of an application submitted under sec-
tion 505(b) or (j) is in effect, the Secretary may require 
by order that information, including specific wording, be 
included in the labeling of a drug on the basis that such
information is necessary to ensure the safe and effective 
use of the drug. 
‘‘(b) NOTIFICATION.—If the Secretary issues an 
order described in subsection (a), the Secretary may re-
quire the manufacturer of the drug involved to notify the 
public and the medical community of the labeling 
change.’’. 
SEC. 6. PUBLIC EDUCATION CAMPAIGN ON RISKS OF CER-
TAIN DRUGS. 
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 
benefits of using a particular drug, whether such risks are 
known at the time of the approval of the drug or become 
known after the approval of the drug. 
SEC. 7. ADDITIONAL FUNDING FOR REGULATION OF DI-
RECT-TO-CONSUMER DRUG ADVERTISING. 
There are authorized to be appropriated to the Food 
and Drug Administration $2,500,000 for each of fiscal 
years 2007 and 2008 for the purpose of regulating direct- 
to-consumer drug advertisements, including by carrying 
out the amendments made by section 2. The authorization 
of appropriations in the preceding sentence is in addition
to any other authorization of appropriations for such pur-
pose. 
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