
[Federal Register Volume 76, Number 82 (Thursday, April 28, 2011)]
[Notices]
[Pages 23821-23823]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-10253]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0230]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Examination of Online Direct-to-Consumer Prescription 
Drug Promotion

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on a series of studies, Examination of Online 
Direct-to-Consumer Prescription Drug Promotion. These studies are 
designed to test different ways of presenting benefit and risk 
information in online direct-to-consumer (DTC) prescription drug Web 
sites.

DATES: Submit either electronic or written comments on the collection 
of information by June 27, 2011.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:  Ila S. Mizrachi, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-7726, e-mail: 
Ila.Mizrachi@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information before 
submitting the collection to OMB for approval. To comply with this 
requirement, FDA is publishing notice of the proposed collection of 
information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Examination of Online Direct-to-Consumer Prescription Drug Promotion--
(OMB Control Number 0910--New)

    Pharmaceutical products are launched and marketed in a number of 
new modalities and venues that did not exist a short time ago. 
Increasingly, prescription products are promoted to consumers online in 
such formats as banner ads, Web sites, and videos. The interactive 
nature of the Internet allows for features not possible with 
traditional media (i.e., print, radio, and television), such as 
scrolling information, pop up windows, linking to more information, and 
embedding videos. FDA regulations require that prescription drug 
advertisements include a ``fair balance'' of information about the 
benefits and risks of advertised products, both in terms of the content 
and presentation of the information (21 CFR 202.1(e)(5)(ii)). All 
prescription drug ads that make claims about a product must, therefore, 
also include risk information in a ``balanced'' manner. Currently, 
there are a number of questions surrounding how to achieve ``fair 
balance'' in online DTC promotion.
    A few studies have examined how well online DTC Web sites 
communicate benefit and risk information. Although content analyses 
demonstrate that most Web sites include information on side effects and 
contraindications (Ref. 1), risk information is often presented less 
prominently and in fewer locations on the Web site (Refs. 2, 3, and 4). 
Content analyses also suggest that risk information on DTC prescription 
drug Web sites is often incomplete (Ref. 5) and written at very high 
literacy levels (Ref. 6).
    One study examined how users interact with prescription drug Web 
sites (Ref. 7). This study found that the placement of risk and benefit 
information on a Web site is an important factor in whether it achieves 
``fair balance.'' Specifically, participants' ability to find and 
accurately recall risk information was enhanced when risk and benefit 
information were presented separately and when risk information was 
presented on a higher order page (i.e., on a second-level page clearly 
linked from the homepage or on the homepage).
    This project is designed to test different ways of presenting 
prescription drug risk and benefit information on branded drug Web 
sites. This research is relevant to current policy questions and debate 
and will complement qualitative research we plan to conduct on issues 
surrounding social media. The original regulations that presently 
determine FDA's position on DTC promotion were written at a time when 
the available media for DTC promotion were print and broadcast, and the 
primary audience was health care professionals. This dynamic is 
shifting, and evidence is needed to support guidance development. The 
series of studies described in this notice will provide data that, 
along with other input and considerations, will inform the development 
of future guidance.
    Design Overview: This research will be conducted in three 
concurrent studies. The first three studies are experimental and the 
fourth is qualitative.
    The purpose of study 1 is to investigate whether the presentation 
of risk information on branded drug Web sites influences consumers' 
perceptions and understanding of the risks and benefits of the product. 
In study 1, we will examine the format (e.g., whether the risk 
information is presented in a paragraph or as a bulleted list) and

[[Page 23822]]

visibility (i.e., the risk information can be seen without scrolling 
down versus the risk information cannot be seen without scrolling down) 
of risk information on the homepage of a prescription drug Web site. 
Participants will be randomly assigned to experimental conditions in a 
factorial design as follows:

                                     Table 1--Study 1 Proposed Design (2x5)
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                                                               Format
                  ----------------------------------------------------------------------------------------------
    Visibility                                                                                      Animated
                       Paragraph         Bullet list         Checklist       Highlighted box      spokesperson
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Scrolling Needed   .................  .................  .................  .................  .................
No Scrolling       .................  .................  .................  .................  .................
 Needed
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    The purpose of study 2 is to investigate how special features such 
as personal testimonial videos and interactive visuals on branded drug 
Web sites influence perceptions and understanding of the risks and 
benefits of the product. Examples of special features we may examine 
include personal testimonial video and interactive mechanism of action 
visuals. We will examine these special features in the context of the 
prominence of the presentation of risk information in two levels, more 
prominent and less prominent. An example of a more prominent display of 
risk information might involve including the risks as part of the 
spoken testimonial, whereas a less prominent display may involve a 
scrolling text of the risks after the animated video. We will include a 
control condition in which participants view a Web page with no special 
features. Participants will be randomly assigned to experimental 
conditions in a factorial design as follows:

                Table 2--Study 2 Proposed Design (2x2+1)
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                                      Special features
                  ------------------------------------------------------
Risk presentation       Personal         Interactive
                      testimonial          visual         Control group
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Prominent          .................  ................
Less Prominent     .................  ................
------------------------------------------------------------------------

    The purpose of study 3 is to investigate whether links to and 
citations from external organizations referenced on the homepage of 
branded drug Web sites influence consumer perceptions and understanding 
of the risks and benefits of the product. We will examine two types of 
information: Hyperlinks to the external organization's Web site (e.g., 
a link to the American Heart Association) and citations from an 
external organization (e.g., a citation to American Heart Association 
guidelines). We will also examine the type of organization (e.g., 
nonprofit or online health community). Participants will be randomly 
assigned to experimental conditions in a factorial design as follows:

                                    Table 3--Study 3 Proposed Design (8x2+1)
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                                                                   Information type
          Organization type          ---------------------------------------------------------------------------
                                       Hyperlink to organization Web site                 Citation
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Government                            ....................................  ....................................
Nonprofit                             ....................................  ....................................
Health Care                           ....................................  ....................................
Health Professions Associations       ....................................  ....................................
Academic                              ....................................  ....................................
Commercial                            ....................................  ....................................
Online Health Community               ....................................  ....................................
Pharmaceutical Company-Sponsored      ....................................  ....................................
 Community
Control Group                         ....................................
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    In these three studies, participants will be randomly assigned to 
view one version of a (fictitious) prescription drug Web site. After 
viewing the Web site, participants will answer a series of questions 
about the drug. We will test how the manipulations affect outcomes such 
as perceived efficacy, perceived risk, behavioral intention, and 
accurate understanding of the benefit and risk information. In each 
study, the fictitious prescription drug will be for the treatment of a 
high prevalence medical condition and modeled on an actual drug used to 
treat that condition. Participants will be consumers who have been 
diagnosed with the medical condition of interest. For instance, the 
medical conditions may be high cholesterol and seasonal allergies for 
study 1, depression and acid reflux disease for study 2, and high blood 
pressure for study 3.
    For studies 1 to 3, interviews are expected to last no more than 25 
minutes (the questionnaire is available upon request). This will be a 
one-time (rather than annual) collection of information.

[[Page 23823]]

    FDA estimates the burden of this collection of information as 
follows:

                                 Table 4--Estimated Annual Reporting Burden \1\
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                                                                                      Average
                                     Number of       Number of     Total annual     burden per
            Activity                respondents    responses per     responses     response  (in    Total hours
                                                    respondent                      hours) \2\
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Screener........................          20,000               1          20,000            2/60             667
Pretests........................           1,200               1           1,200           20/60             400
Study 1.........................           4,000               1           4,000           25/60           1,667
Study 2.........................           2,000               1           2,000           25/60             834
Study 3.........................           3,600               1           3,600           25/60           1,500
    Total.......................  ..............  ..............  ..............  ..............           5,068
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Burden estimates of less than 1 hour are expressed as a fraction of an hour in the format ``[number of
  minutes per response]/60''.

I. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES) and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday.

1. Macias, W. and L. Stavchansky Lewis, ``How Well Do Direct-to-
Consumer (DTC) Prescription Drug Web Sites Meet FDA Guidelines and 
Public Policy Concerns?'' Health Marketing Quarterly, vol. 22, pp. 
45-71, 2005.
2. Hicks, K. E., M. S. Wogalter, and W. J. Vigilante, Jr., 
``Placement of Benefits and Risks in Prescription Drug 
Manufacturers' Web Sites and Information Source Expectations,'' Drug 
Information Journal, vol. 39, pp. 267-278, 2005.
3. Huh, J. and B. J. Cude, ``Is the Information `Fair and Balanced' 
in Direct-to-Consumer Prescription Drug Web Sites?'' Journal of 
Health Communication, vol. 9, pp. 529-540, 2004.
4. Sheehan, K. B., ``Direct-to-Consumer (DTC) Branded Drug Web Sites 
Risk Presentation and Implications for Public Policy,'' Journal of 
Advertising, vol. 36, pp. 123-135, 2007.
5. Davis, J. J., E. Cross, and J. Crowley, ``Pharmaceutical Web 
Sites and the Communication of Risk Information,'' Journal of Health 
Communication, vol. 12, pp. 29-39, 2007.
6. Naik, S. and S. P. Desselle, ``An Evaluation of Cues, 
Inducements, and Readability of Information on Drug-Specific Web 
Sites,'' Journal of Pharmaceutical Marketing and Management, vol. 
17, pp. 61-81, 2007.
7. Vigilante, Jr., W. J., and M. S. Wogalter, ``Assessing Risk and 
Benefit Communication in Direct-to-Consumer Medication Web Site 
Advertising,'' Drug Information Journal, vol. 39, pp. 3-12, 2005.

    Dated: April 22, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-10253 Filed 4-27-11; 8:45 am]
BILLING CODE 4160-01-P


