I 
109TH CONGRESS 
1ST SESSION H. R. 3696 
To amend the Federal Food, Drug, and Cosmetic Act to require prior ap-
proval by the Food and Drug Administration of advertisements for pre-
scription drugs and restricted medical devices, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
SEPTEMBER 8, 2005 
Mr. BROWN of Ohio 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 to 
require prior approval by the Food and Drug Adminis-
tration of advertisements for prescription drugs and re-
stricted medical devices, 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 ‘‘Medical Advertising 
Reform Act’’.
TITLE I—LABELING AND ADVER-
TISING FOR PRESCRIPTION 
DRUGS 
SEC. 101. ADVERTISING FOR PRESCRIPTION DRUGS. 
(a) ADVERTISEMENTS INTENDED FOR CONSUMERS; 
PRIOR APPROVAL.—Section 502(n) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 352(n)) is amended 
by striking ‘‘except that (A)’’ and all that follows through 
‘‘and (B)’’ and inserting the following: ‘‘provided that 
(A)(i) in the case of an advertisement intended for con-
sumers of a prescription drug, such regulations shall re-
quire prior approval by the Secretary of the content of 
the advertisement, which approval or denial shall be issued 
not later than 30 days after the content is submitted to 
the Secretary, and (ii) in the case of an advertisement not 
so intended, such regulations may not, except in extraor-
dinary circumstances, require prior approval by the Sec-
retary of the content of the advertisement, and (B)’’. 
(b) TWO-YEAR PROHIBITION AFTER APPROVAL OF 
DRUG.— 
(1) IN GENERAL.—Section 505(c) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 
355(c)) is amended by adding at the end the fol-
lowing paragraph:
‘‘(5)(A) In the case of a prescription drug, the Sec-
retary shall require as a condition of the approval of an 
application under subsection (b) that the applicant ensure 
that no advertisement for the drug is issued or caused to 
be issued during the two-year period beginning on the date 
on which the application is approved. 
‘‘(B) The Secretary, after notice and opportunity for 
a hearing, may extend the two-year period under subpara-
graph (A) if the Secretary determines that such extension 
is necessary to protect the public health.’’. 
(2) ENFORCEMENT.—Section 502 of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 352) 
is amended by adding at the end the following: 
‘‘(x) If it is a prescription drug with respect to which 
there is a failure to comply with a requirement under sec-
tion 505(c)(5).’’. 
(c) RULE
OF CONSTRUCTION.—The amendments 
made by subsections (a) and (b) may not be construed 
as affecting the authority of the Secretary of Health and 
Human Services under section 319 of the Public Health 
Service Act (relating to actions to respond to public health 
emergencies).
SEC. 102. LABELING AND ADVERTISING FOR PRESCRIP-
TION DRUGS; REPORT TO CONGRESS RE-
GARDING 
COMPARATIVE 
EFFECTIVENESS 
AND COST-EFFECTIVENESS. 
Not later than one year after the date of the enact-
ment of this Act, the Secretary of Health and Human 
Services, acting through the Commissioner of Food and 
Drugs, shall submit to the Committee on Energy and 
Commerce in the House of Representatives, and the Com-
mittee on Health, Education, Labor, and Pensions in the 
Senate, a report providing a proposal for the inclusion in 
the labeling and advertisements for each prescription drug 
of information concerning the comparative effectiveness 
and comparative cost-effectiveness of the drug in relation 
to other prescription drugs that are in the same class of 
drugs. Such report shall include a description of the 
amendments to the Federal Food, Drug, and Cosmetic Act 
that would be necessary to enact such proposal. 
SEC. 103. FUNDING FOR DIVISION OF DRUG MARKETING, 
ADVERTISING, AND COMMUNICATIONS. 
For carrying out the responsibilities of the Division 
of Drug Marketing, Advertising, and Communications 
(within the Office of Medical Policy, Center for Drug 
Evaluation and Research, Food and Drug Administra-
tion), there are authorized to be appropriated $25,000,000
for fiscal year 2007, and such sums as may be necessary 
for each subsequent fiscal year. 
TITLE II—ADVERTISING FOR 
RESTRICTED MEDICAL DEVICES 
SEC. 201. ADVERTISING FOR RESTRICTED DEVICES. 
(a) ADVERTISEMENTS INTENDED FOR CONSUMERS; 
PRIOR APPROVAL.—Section 502(r) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 352(r)) is amended— 
(1) by inserting after the first period the fol-
lowing: ‘‘In the case of an advertisement intended 
for consumers of a restricted device, regulations 
under this paragraph shall require prior approval by 
the Secretary of the content of the advertisement, 
which approval or denial shall be issued not later 
than 30 days after the content is submitted to the 
Secretary.’’; and 
(2) by striking ‘‘Except in extraordinary cir-
cumstances’’ and all that follows through ‘‘prior ap-
proval’’ and inserting the following: ‘‘In the case of 
an advertisement not so intended, such regulations 
may not, except in extraordinary circumstances, re-
quire prior approval’’. 
(b) STUDY BY GOVERNMENT ACCOUNTABILITY OF-
FICE; REPORT TO CONGRESSIONAL COMMITTEES.—
(1) IN GENERAL.—The Comptroller General of 
the United States shall conduct a study on the im-
pact of consumer-directed advertising on restricted 
device utilization and spending. Such study shall 
consider, for the period January 1, 2001, through 
December 31, 2005— 
(A) the growth in retail sales of the 25 re-
stricted devices most heavily advertised (as 
measured by the volume of advertisements aired 
or published) relative to the sales of other re-
stricted devices; 
(B) annual retail price increases of the 25 
most heavily advertised devices compared to 
those of other devices; and 
(C) such other information as the Comp-
troller General determines is useful in assessing 
the impact of advertising on the national health 
care consumption and spending. 
(2) EVALUATION
OF
REGULATORY
CONTROLS 
AND SUFFICIENCY OF RESOURCES.— 
(A) IN
GENERAL.—In conducting the 
study under paragraph (1), the Comptroller 
General shall, in addition to considerations 
under such paragraph, evaluate whether—
(i) current regulatory controls are de-
signed and implemented so as to effectively 
ensure that consumer-directed device ad-
vertising provides complete and accurate 
information concerning the safety and ef-
fectiveness considerations associated with 
advertised devices; and 
(ii) the Food and Drug Administra-
tion devotes sufficient resources to the 
tasks of monitoring and enforcing such 
controls. 
(B) RECOMMENDATIONS FOR CONGRESS.— 
If the Comptroller General concludes that the 
design or implementation of current regulatory 
controls is ineffective within the meaning of 
subparagraph (A)(i), or that the resources allo-
cated for their implementation are insufficient 
within the meaning of subparagraph (A)(ii), the 
Comptroller General shall develop recommenda-
tions for the Congress for remediation of the 
deficiencies. 
(3) DEFINITIONS.—For purposes of this sub-
section, the terms ‘‘device’’ and ‘‘restricted device’’ 
have the meanings that apply for purposes of the 
Federal Food, Drug, and Cosmetic Act.
(4) REPORT.—Not later than July 1, 2006, the 
Comptroller General shall submit to the Committee 
on Energy and Commerce in the House of Rep-
resentatives, and the Committee on Finance in the 
Senate, a report providing the findings of the study 
under paragraph (1), including (as applicable) rec-
ommendations under paragraph (2)(B). 
SEC. 202. FUNDING FOR OFFICE OF COMPLIANCE. 
For carrying out the responsibilities of the Office of 
Compliance (within the Center for Devices and Radio-
logical Health, Food and Drug Administration), there are 
authorized to be appropriated $5,000,000 for each of the 
fiscal years 2007 through 2009, and such sums as may 
be necessary for each subsequent fiscal year. 
TITLE 
III—AVAILABILITY 
TO 
PUBLIC OF OBJECTIVE IN-
FORMATION ON DRUGS 
SEC. 301. AVAILABILITY OF INFORMATION. 
(a) IN GENERAL.—The Secretary of Health and 
Human Services shall provide for the availability to the 
public of objective information on health conditions and 
treatments through— 
(1) maintaining a toll-free telephone number to 
provide such information;
(2) carrying out a public information campaign 
to make the public aware that such information is 
available from the Department of Health and 
Human Services through such telephone number and 
through the Internet site www.healthfinder.gov (or 
successor site); and 
(3) using the telephone number under para-
graph (1), and the Internet site of the Food and 
Drug Administration, to make the public aware of 
the Internet site referred to in paragraph (2). 
(b) AUTHORIZATION OF APPROPRIATIONS FOR PUB-
LIC INFORMATION CAMPAIGN.—For the purpose of car-
rying out subsection (a)(2), there are authorized to be ap-
propriated such sums as may be necessary for each of the 
fiscal years 2007 through 2009. 
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