FTC Staff Comment Before the Food and Drug Administration Concerning Consumer-Directed Promotion

BEFORE THE
DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
In the Matter of
Request for Comments on Agency Draft Guidance Documents
Regarding Consumer-Directed Promotion
Docket No. 2004D-0042
Comments of the Staff of
the Bureau of Consumer Protection,
the Bureau of Economics,
and the Office of Policy Planning
of the Federal Trade Commission
May 10, 2004*
__________________________________________________________________
*These comments represent the views of the staff of the Bureau of Consumer
Protection, the Bureau of Economics, and the Office of Policy Planning of the
Federal Trade Commission. They do not necessarily represent the views of
the Federal Trade Commission or any individual Commissioner. The
Commission has, however, voted to authorize the staff to submit these
comments.
__________________________________________________________________

1 See 69 Fed. Reg. 6308 (Feb. 10, 2004).
2 Id.
I. Introduction
On February 4, 2004, the Food and Drug Administration (“FDA”) issued three draft
guidances designed to improve the information that consumers and health care practitioners
receive in advertising about prescription drugs and certain medical devices. 1 The first guidance
(the “Brief Summary Guidance”) would permit advertisers to include more limited and focused
“brief summary” information in direct-to-consumer (“DTC”) advertisements for prescription
drugs. The second guidance (the “Disease Awareness Guidance”) would clarify when the FDA
would treat a communication as a “help-seeking communication” over which it lacks
jurisdiction. The third guidance (the “Device Broadcast Advertising Guidance”) would apply
the same regulatory standards to DTC broadcast ads for restricted medical devices that apply to
DTC broadcast ads for prescription drugs.
The FDA has sought public comment on the three proposed guidances. 2 As explained
below, the staff of the Federal Trade Commission’s Bureaus of Consumer Protection and
Economics as well as its Office of Policy Planning (“FTC staff”) believe that the proposed
guidances represent substantial progress toward the FDA’s goal of finding the appropriate means
to convey relevant risk information to consumers in a manner that they can understand.
Specifically, the FTC staff concludes that:
• 	The FDA’s proposed new options to meet the brief summary requirement for
DTC print ads for prescription drugs might be a significant improvement over the
current brief summary requirement. The FDA, however, should conduct
consumer research to determine whether these proposed options, or other formats,

3 15 U.S.C. § 45.
4 15 U.S.C. § 52.
5 Working Agreement Between FTC and Food and Drug Administration, 4 Trade
Reg. Rep. (CCH) ¶ 9,851 (1971).
3
are the most effective means of providing drug risk information in DTC print ads.
• 	The FTC staff agrees with the FDA’s suggestion that the Commission has
jurisdiction over help-seeking communications related to prescription drugs under
Section 5 of the FTC Act.
• 	The FTC staff supports the FDA’s proposal to extend the same brief summary
requirement for DTC broadcast ads for prescription drugs to DTC broadcast ads
for restricted medical devices. The staff believes that adoption of this proposal
will likely lead to increased advertising for restricted medical devices, thereby
benefitting consumers and competition.
II. Background
The FTC enforces Section 5 of the Federal Trade Commission Act (“FTC Act”), which
broadly prohibits “deceptive or unfair acts or practices in or affecting commerce.” 3 Section 12 of
the FTC Act more specifically prohibits the dissemination of false advertisements for foods,
drugs, devices, services, or cosmetics. 4 Although the FDA and the FTC generally share
jurisdiction over prescription drug advertising, the FDA exercises primary responsibility for such
advertising pursuant to a memorandum of understanding between the two agencies.5
One of the FTC’s primary responsibilities is to bring law enforcement actions against

6 See, e.g., P. Ippolito & J. Pappalardo, Advertising Nutrition & Health: Evidence
from Food Advertising 1977-1997 (2002); P. Ippolito & A. Mathios, Information and
Advertising Policy: A Study of Fat and Cholesterol Consumption in the United States, 1977-
1990 (1996); J. Calfee & J. Pappalardo, How Should Health Claims for Foods Be Regulated? An
Economic Perspective (1989); A. Masson & R. Steiner, Generic Substitution and Prescription
Drug Prices: Economic Effects of State Drug Product Selection Laws (1985).
7 Comments of the Staff of the Bureau of Consumer Protection, the Bureau of
Economics, and the Office of Policy Planning of the Federal Trade Commission in the Matter of
Request for Comments on Consumer-Directed Promotion, Docket No. 2003N-0344 (2003)
(hereafter “FTC 2003 DTC Comment”); Comments of the Staff of the Bureau of Economics, the
Bureau of Consumer Protection, and the Office of Policy Planning of the Federal Trade
Commission in the Matter of Request for Comment on First Amendment Issues, Docket No. 02N-
0209 (2002); Comments of the Staff of the Bureau of Consumer Protection and the Bureau of
Economics of the Federal Trade Commission in the Matter of Direct-to-Consumer Promotion,
Public Hearing Docket No. 95N-0227 (1996).
8 21 U.S.C. § 352(n).
4
deceptive practices in national advertising. Through these law enforcement activities and
through research conducted in support of its mission, the FTC has developed considerable
expertise in analyzing the role of advertising in conveying health-related information to
consumers and the effect of advertising regulation on consumers and competition. 6 In particular,
the FTC staff has submitted three previous comments to the FDA relating to DTC advertising for
prescription drugs. 7 In our comments, we have emphasized that truthful, non-misleading DTC
advertising benefits consumers by providing them with useful information about their healthcare
and treatment options. False or misleading ads for prescription drugs, however, can misinform
consumers about the effectiveness and side effects of their medications.
III. The FDA’s Brief Summary Guidance Requirements for DTC Print Ads
The Federal Food, Drug, and Cosmetic Act (“FDCA”) requires that prescription drug
advertising contain a true statement of “information in brief summary relating to the side effects,
contraindications, and effectiveness” of the drug (the “brief summary requirement”).8 FDA’s

9 62 Fed. Reg. 43,171 (Aug. 12, 1997) (citing 21 C.F.R. § 202.1(e)(1) and
(e)(3)(iii)). Note that the approved package labeling is also sometimes called the “package
insert” or “product package insert.”
10 See FDA, Guidance for Industry: Consumer-Directed Broadcast Advertisements
(Aug. 9, 1999), available at www.fda.gov/cder/guidance/1804fnl.htm; see also 64 Fed. Reg.
43,197 (announcing final guidance document).
11 See FDA, Draft Guidance for the Industry: Using FDA-Approved Patient
Labeling in Consumer-Directed Print Advertisements (April 2001), available at
www.fda.gov/cder/guidance/4114dft.pdf. Although guidance documents are not legally binding
on the FDA or the public, they do provide the FDA’s current thinking on an issue and provide
5
implementing regulations specify that the information about risks in the “brief summary” must
“disclose all the risk-related information in [a drug’s FDA-approved] package labeling.”9
Pharmaceutical manufacturers usually meet the brief summary requirement for DTC print
ads by including the entire section of the FDA-approved product labeling that discusses side
effects and contraindications of the drug. The product labeling often runs to a page or more of
“fine print” text in magazines and other publications.
In 1999, the FDA recognized the inherent limitations in trying to incorporate all of the
brief summary information from the FDA-approved product labeling into DTC broadcast ads,
especially television ads. The agency, therefore, issued a guidance stating that DTC broadcast
ads only have to include a “major statement” of risks and make “adequate provision” for
consumers to obtain the FDA-approved product labeling.10 The FDA, however, did not change
the requirements for DTC print ads.
The FDA has sought to address the issues that the brief summary requirement for print
ads raises. In its 2001 draft guidance document addressing print ad disclosures, the FDA
acknowledged that consumers need different types and amounts of information about medical
risks than medical professionals. 11 The agency therefore encouraged drug manufacturers to use

consistency and predictability. See 62 Fed. Reg. 8961, 8962-63 (Feb. 27, 1997).
12 See Draft Guidance, supra n.11.
13 Id. FDA-approved patient labeling is also called “Information for the Patient,”
“Patient Information,” “Medication Guide,” and “patient package inserts.”
14 Id. at 2.
15 See FTC 2003 DTC Comment, 20-22.
16 Id.
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more consumer-friendly language in the brief summary in their print ads. 12 Thus, in lieu of
providing the entire section of FDA-approved product labeling, a manufacturer can satisfy the
brief summary requirement for print ads by reprinting FDA-approved patient labeling, if such
labeling in available.13 Although the FDA-approved patient labeling does not disclose every
specific risk included in the product labeling, it is designed to present the drug’s most serious
and most common risks and is intended to be written at a level that is easier for consumers to
understand than the FDA-approved product labeling.14
In 2003, the FDA requested comment on DTC ads, including whether its current
regulatory approach should be modified. The FTC staff filed a comment recommending, among
other things, that the FDA generally retain its brief summary requirement for DTC broadcast
ads. 15 The staff comment also recommended that the FDA apply the brief summary requirement
for DTC broadcast ads to DTC print ads: namely, (1) a major statement of the risks of the drug,
and (2) adequate provision for consumers to obtain more complete risk information, preferably
in the form of the FDA-approved patient labeling, if available.16
In the proposed Brief Summary Guidance, the FDA proposes to allow manufacturers two
options to satisfy the brief summary requirement for DTC print ads. The first would require

17 The FDA would not object, however, to the use of only the risk information from
the FDA-approved patient labeling.
18 In 2000, the FDA determined that FDA-approved product labeling was not
effective in conveying risk information even to physicians and other medical professionals.
Requirements on Content and Format of Labeling for Human Prescription Drugs and Biologics;
Requirement for Prescription Drug Product Labels, 65 Fed. Reg. 81,082 (Dec. 22, 2000). To
address this concern, the FDA issued a proposed rule that would require the FDA-approved
product labeling to include a new section, “Highlights of Prescribing Information,” that would
set forth in a concise manner the information that is most important for safe and effective use.
The proposed rule is not yet a final rule.
19 Although the proposed rule that would allow the Highlights section has not yet
become effective, the FDA would not object to the use of this section in DTC advertising.
20 The FTC staff recognizes that the draft Brief Summary Guidance would not apply
to all DTC print ads. The FDA has not approved patient labeling for most of the innovator drugs
that it has approved in the past few years. See 2003 FTC Staff Comment at 27 n.71. Moreover,
many manufacturers may not have developed a Highlights section for FDA-approved product
7
manufacturers to include risk information from the more consumer-friendly FDA-approved
patient labeling in DTC print ads. Under this option, manufacturers would have to reprint the
patient labeling in full plus those sections of the product labeling concerning contraindications,
warnings, major precautions, and most common adverse reactions.17
The second option would require manufacturers to include in print ads risk information
from the “Highlights” section of the FDA-approved product labeling.18 This option would
include information about contraindications, warnings, major precautions, and most common
adverse reactions.19 Because the Highlights section of the product labeling has been written for
medical professionals, however, the FDA recommends that manufacturers rewrite the section in
language that is understandable to consumers.
The FTC staff believes that requiring the disclosure of risk information in a more
consumer-friendly format would be an improvement over the current brief summary requirement
for DTC print ads.20 The proposed change would mandate a more concise and consumer-

labeling, because the agency has not yet issued a final rule relating to the Highlights section.
21 Given the length and complexity of the current brief summary disclosure,
standard copy test procedures may not accurately gauge the attention consumers would give such
an extensive disclosure under more natural conditions. The consumer research should therefore
be designed, and the results interpreted, with this consideration in mind.
22 The FDA may want to test whether the inclusion in these options of
contraindication, warning, major precaution, and common adverse reaction information from the
product labeling improves consumer understanding of risk.
8
oriented statement of risks, which makes it more likely that consumers will read and understand
this information than the current risk information cribbed from the FDA-approved product
labeling. Moreover, to the extent that the proposed change would decrease the disparity between
the brief summary requirements for DTC print ads and DTC broadcast ads, the current regulatory
incentive to use DTC broadcast ads to compete may be decreased, although not eliminated.
The FDA has asked for consumer research concerning the costs and benefits of the brief
summary options contained in the draft Brief Summary Guidance. The FTC staff is not aware of
any empirical research demonstrating whether the options would be effective in communicating
risk information to consumers, or the costs associated with using these options. We strongly
support the FDA’s willingness to conduct and consider such research.
The FTC staff encourages the FDA to test the likelihood that consumers will read 21 and
understand drug risks in DTC print ads with: (1) no brief summary information; (2) the brief
summary information contained in broadcast ads (i.e., a major statement of risks plus adequate
provision to receive more complete information); (3) the proposed new brief summary
information options22 (adapted patient labeling or Highlights); and (4) the currently required
brief summary information (i.e., FDA-approved product labeling). Such research would provide
insight into the costs and benefits of including different amounts of risk information in DTC

23 See Murray et al., Public Policy Relating to Consumer Comprehension of
Television on Commercials: A Review and Some Empirical Results, 16 J. Consumer Pol’y 145,
155, 160-161 (1993) (demonstrating that the number of words in a disclosure is negatively
correlated with comprehension); Murphy & Richards, Investigation of the Effects of Disclosure
Statements in Rental Car Advertisements, 26 J. Consumer Aff. 351, 355-356 (1992). Murphy
and Richards find that if the amount of information presented exceeds consumers’ ability to
process it, the quality of consumer decision-making may be negatively affected. Murphy and
Richards further state that “[a]lthough any efforts by regulators to facilitate informed decision-
making may be laudable, failure to ensure that the chosen method of presentation is appropriate
for consumer use can make those regulations worthless or even detrimental to consumer
interests. If consumers are unable to understand or recall the information in the legally mandated
form another disclosure technique...may be more efficacious.” Id. at 373.
24 See 2003 FTC Staff Comment at 23 n.62.
25 The FDCA does not specifically define “advertising” or “advertisement.”
According to FDA regulations, “advertisements subject to Section 502(n) of the act include
advertisements in published journals, magazines, other periodicals, and newspapers, and
advertisements broadcast through media such as radio, television, and telephone communication
systems.” 21 C.F.R § 202.1(1)(1). The FDCA defines “label” to mean “a display of written,
9
print ads. As the amount of risk information in such ads increases, consumers who read and
understand the information may benefit. On the other hand, the increased risk information may
deter some consumers from reading the information or may make it more difficult for them to
comprehend.23 Moreover, including highly-detailed risk information may increase the cost of
running DTC print ads, thereby decreasing manufacturers’ incentive to run such ads.24 The FTC
staff believes that this broader research focus will assist the FDA in determining the costs and
benefits of these alternative options for presenting risk information, thus providing the agency
with an empirical basis for selecting the best method of conveying such information to
consumers in DTC print ads.
IV. The FDA’s Disease Awareness Guidance
The FDA has stated that it has jurisdiction under the FDCA over drug “advertising” and
“labeling.” 25 The agency has concluded that it does not have authority over help-seeking

printed, or graphic matter upon the immediate container of any article. . .” 21 U.S.C. § 321(k).
“Labeling” means “all labels and other written, printed, or graphic matter (1) upon any article or
any of its containers or wrappers, or (2) accompanying such article.” 21 U.S.C. § 321(m).
26 See 69 Fed. Reg. 6308 (Feb. 10, 2004).
27 Id.
28 See FDA, Draft Guidance for Industry: “Help-Seeking” and Other Disease
Awareness Communications by or on Behalf of Drug and Device Firms (Jan. 2004) at 4 n.4,
available at www.fda.gov/cder/guidance/6019dft.doc.
29 15 U.S.C. § 45.
10
communications – communications that encourage consumers to seek treatment for a disease or
medical condition but do not mention a particular drug. 26 The draft Disease Awareness
Guidance that the FDA recently issued seeks to clarify its standards for determining whether
communications are such “help-seeking communications” rather than drug “advertising” or
“labeling.” 27 In particular, the draft guidance emphasizes that the FDA will consider a help-
seeking communication and a product ad as “advertising” over which the agency has jurisdiction
if the two communications are not perceptually distinct.
The draft Disease Awareness Guidance also suggests that the FTC has jurisdiction over
help-seeking communications under Section 5 of the FTC Act.28 The FTC staff agrees with the
FDA’s suggestion that the Commission would have jurisdiction over claims made in such
communications even though they do not mention a particular drug. Under Section 5 of the FTC
Act, the FTC could investigate and challenge help-seeking communications if they appeared to
be “unfair or deceptive acts and practices.”29
V. The FDA’s Device Broadcast Advertising Guidance
When the FDA eased the brief summary requirement for DTC broadcast ads in the late

30 According to FDA, the devices covered by the Device Broadcast Advertising
Guidance are those it has designated as “restricted” either by regulation promulgated under
Section 520(e) of the FDCA (21 U.S.C. § 360j(e)) or by premarket approval application approval
order pursuant to section 515(d)(1)(B)(ii) (21 U.S.C. § 360e(d)(1)(B)(ii)).
31 The FDA issued its proposed changes in brief summary requirements for DTC
broadcast ads in late 1996 and issued a final guidance document with these changes in 1999. In
1996, the industry spent $791 million on DTC ads. In 2000, the industry spent $2.467 billion on
DTC ads. M. Rosenthal et al., Special Article: Promotion of Prescription Drugs to Consumers,
346 New. Eng. J. Med. 498 (Feb. 14, 2002), available at www.nejm.org.
11
1990's, the agency expressly excluded DTC broadcast ads for “restricted” medical devices.
These are medical devices (e.g., pacemakers, corrective contact lenses, hearing aids) that the
FDA has determined cannot be used safely without medical supervision and therefore are
available only pursuant to a prescription.30 The draft Device Broadcast Advertising Guidance
would now apply the same, less burdensome, brief summary requirement to DTC broadcast ads
for restricted medical devices that it has been applying to DTC broadcast ads for prescription
drugs.
The current brief summary requirement for DTC broadcast ads for restricted medical
devices provides a substantial disincentive for manufacturers to use such ads. As discussed
above, the FDA recognized that including all of the risk information from the FDA-approved
product labeling in DTC broadcast ads for prescription drugs was so onerous that these ads were
not a realistic option for manufacturers. We believe that the current brief summary requirement
for DTC broadcast ads for restricted medical devices would be likely to have the same effect.
Easing the brief summary requirements for DTC broadcast ads for restricted medical
devices is likely to cause a substantial increase in the number of these ads. When the FDA eased
the brief summary requirement for DTC broadcast ads for prescription drugs, there was an
extraordinary increase in these types of ads.31 Indeed, there are anecdotal reports that restricted

32 R. Thomaselli, Medical Devices to Hike Spending, Advertising Age (Feb. 16,
2004).
33 FTC 2003 DTC Comment at 15. The quoted language from the FTC 2003 DTC
Comment refers to the effects of all DTC advertising for prescription drugs. Given that DTC
broadcast ads account for more than 64% of DTC advertising for prescription drugs, see The
Henry J. Kaiser Foundation, Trends in Direct-to-Consumer Advertising of Prescription Drugs 5
(Feb. 2002), it is reasonable to attribute these effects to DTC broadcast ads as well.
12
device manufacturers are already considering modifying the methods that they use to market
their products in response to the issuance of the FDA’s draft Device Broadcast Advertising
Guidance.32
Based on our analysis of the effect of changes in FDA’s regulatory scheme for DTC ads
for prescription drugs, the FTC staff believes that consumers are likely to benefit from changes
in FDA regulations that are likely to increase DTC broadcast advertising for restricted medical
devices. In assessing the effect of FDA’s measures to decrease the regulatory burden associated
with DTC broadcast advertising for prescription drugs, the FTC staff stated that:
The evidence currently available suggests that DTC advertising has had some positive
effects for consumers. DTC advertising appears to provide drug benefit and risk
information that prompts consumers to seek out information about medications and
medical conditions, some of which may not have been diagnosed previously. The
information that consumers acquire may allow them to have more fruitful, informed
conversations with their doctors about treatment options and may permit them to make
better-informed health care decisions for themselves. In some cases, however, DTC ads
may create misimpressions about drug risks and benefits, and doctors may have to correct
these misimpressions and not let them affect their prescribing decisions. Definitive
conclusions regarding the precise nature of the impact of the FDA’s current approach to
DTC advertising on consumer welfare cannot be reached, however, until better empirical
evidence is developed concerning the effects of DTC advertising on both drug
expenditures and health outcomes.33
Given that prescription drugs and restricted medical devices are both products sold pursuant to a
prescription from a medical professional, the FTC staff believes that adopting the same brief
summary requirement that applies to DTC broadcast ads for prescription drugs to such ads for

13
restricted medical devices would have similar effects.
V. Conclusion
In light of the important role that DTC advertising can play in keeping consumers better-
informed about their healthcare and treatment options, the FTC staff supports the FDA’s effort to
improve the facilitation of truthful, non-misleading information in DTC advertising by issuing
three draft guidance documents on consumer-directed promotion. The FTC staff believes that
the proposed guidances provide needed clarification and consistency that will aid in this
endeavor.
Respectfully submitted,
__________________________
J. Howard Beales III, Director
Thomas B. Pahl, Assistant Director, Division of Advertising Practices
Rielle C. Montague, Attorney
L. Mark Eichorn, Attorney
Bureau of Consumer Protection

14
__________________________
Luke Froeb, Director
Pauline M. Ippolito, Associate Director
Joseph P. Mulholland, Economist
Bureau of Economics
__________________________
Todd J. Zywicki, Director
Maureen K. Ohlhausen, Deputy Director
Office of Policy Planning