CDER DTC Advertising Survey SS Part A

National Direct-to-Consumer Advertising Survey
OMB Control No. 0910- NEW
Supporting Statement Part A

1. Circumstances Making the Collection of Information Necessary
Section 1701(a)(4) of the Public Health Service Act (42 U.S.C. 300u(a)(4)) authorizes the Food
and Drug Administration (FDA) to conduct research relating to health information. Section
1003(d)(2)(c) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C.
393(d)(2)(c)) authorizes FDA to conduct research relating to drugs and other FDA regulated
products in carrying out the provisions of the FD&C Act.
FDA last surveyed patients about their experiences with and attitudes toward DTC advertising in
2002 (Ref. 1). Numerous changes have affected the DTC landscape since 2002, including
declines in print readership, the rise in online prescription drug promotion, and self-imposed
industry guidelines for DTC advertising (Ref. 2). These changes may have affected consumers'
exposure to different kinds of DTC advertising and its influence on their attitudes and behaviors.
2. Purpose and Use of the Information Collection
The purpose of this survey is to collect updated insights on consumer experiences with and
attitudes towards DTC promotion of prescription drugs. This study will build on previous
research by recruiting a wider range of respondents, weighting the data to make it nationally
representative, and asking a wider range of questions about DTC promotion, including in online
formats.
3. Use of Improved Information Technology and Burden Reduction
Automated information technology will be used in the collection of information for this study.
We plan to use an address-based mixed-mode methodology that will direct one randomly-chosen
member of sampled households to complete a 20-minute online survey, with non-respondents
receiving a paper questionnaire. In addition to its use in data collection, automated technology
will be used in data reduction and analysis. Burden will be reduced by recording data on a onetime basis for each participant, and by keeping surveys to less than 20 minutes.
4. Efforts to Identify Duplication and Use of Similar Information
FDA last surveyed patients about their attitudes toward DTC advertising in 2002 (Ref. 1).
Although recent surveys have included a few questions about DTC advertising (e.g., Refs. 3, 4),
there are few, if any, recent nationally representative surveys devoted to DTC advertising (Ref.
5). Changes in the DTC landscape outlined above call for a new nationally representative survey
specifically on DTC advertising.

5. Impact on Small Businesses or Other Small Entities
No small businesses will be involved in this data collection.
6. Consequences of Collecting the Information Less Frequently
The proposed data collection is one-time only. There are no plans for successive data
collections.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances for this collection of information.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
Agency
In accordance with 5 CFR 1320.8(d), FDA published a 60 day notice for public comment in the
Federal Register of February 29, 2016 (81 FR 10257). Nine comments were received. Five
comments did not address any of the information collection topics solicited and therefore we do
not discuss them in this document (four called for a ban on direct-to-consumer prescription drug
advertising and one discussed FDA’s response to public comments in general). No comments
addressed Topic (2) -- accuracy of our estimate.
Topic (1) – practical utility. One comment suggested that we increase the practical utility of the
survey by (1) including teenagers 14-18 years of age and (2) skewing the survey to include a
disproportionate number of Americans over 50 years of age. Another comment suggested we
use a quota to ensure that limited literacy respondents are included. One of our main goals is to
survey a nationally representative sample of U.S. adults about their experiences with and
attitudes towards DTC promotion of prescription drugs. Note that we have designed other
studies that specifically examine adolescent and older adults’ responses to prescription drug
advertising (FDA-2013-N-1151-0004, “Experimental Study of Direct-to-Consumer Promotion
Directed at Adolescents;” FDA-2015-N-2163-000, “Hearing, Aging, and Direct-to-Consumer
Television Advertisements”). We will measure health literacy within the survey.
One comment suggested that respondents should watch a prescription drug television ad and then
answer questions about benefit and risk recall. Although this design is beyond what we can
accomplish within a nationally representative survey, we have conducted studies that use this
design (for examples, see
http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/uc
m090276.htm).
Topic (3) – ways to enhance quality, clarity, utility. Four comments suggested changes to the
survey to enhance its quality, clarity, and utility. First, three comments suggested changing our
terminology throughout the survey for clarity. As suggested, we changed “television” to “TV,”
“advertisement” to “ad,” used “health care provider” throughout the survey, and specified that by
Internet we mean Internet accessed by computer, phone, or tablet. We changed “small print” to

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“additional information.” We did not change “prescription drug” to “medicine.” Respondents in
cognitive interviews understood the term “prescription drug,” and we are concerned that
“medicine” is too broad. We also chose not to highlight or bold “prescription drug” as cognitive
interview respondents understood the purpose of the survey and we do not want to overuse
highlighting.
Second, two comments suggested deleting survey questions. Two comments questioned the
utility of a series of questions about the safety and efficacy of certain products. We agree that
these questions are not as central to the survey topic and have deleted them. They also
recommended deleting a series of questions about FDA approval of DTC promotion. These
questions will highlight claims within the ad to determine whether consumers believe that
advertising in general as well as specific claims are approved by FDA. Therefore, we have
chosen to keep these questions on the survey. One comment recommended deleting a question
perceived to be too negative whereas another comment recommended adding positive answer
choices to balance the question; we chose the latter option.
Third, four comments suggested additional topics for survey questions. In response we added
questions about whether prescription drug advertising has caused respondents to talk with their
healthcare provider about symptoms or side effects they’ve experienced, or to look for
information about a prescription drug they thought might be helpful for a friend of family
member. We also added a question about the respondents’ primary language. Finally, we now
ask whether respondents have seen prescription drug promotion on streaming services and
whether they have looked for information on medical association websites.
One comment suggested adding places where consumers could see or hear advertisements (e.g.,
“on television at the doctor’s office,” “in a pharmacy”) to a question that asks about the type of
medium where they saw or heard an ad (e.g., “TV,” “print”). We chose not to take this
suggestion because the question concerns medium, not location. We are also concerned about
measurement error. For instance, some doctor’s offices have magazines with DTC print ads, TVs
playing broadcast television, or TVs playing videos. This also relies on having gone to a doctor
or pharmacist in the last three months.
One comment suggested adding additional response options to a question about where
consumers might attain more information about prescription drugs. Because this question is
focused on adequate provision in DTC television ads, we chose not to add any additional
response options beyond those specific to adequate provision (i.e., branded website,
manufacturer’s toll-free number, print ad, and health care provider).
We note that the survey contains a series of questions about various new media, including social
media, websites, and online videos. It also asks about respondents’ attitudes about how benefits
and risks are presented, whether they have seen information about the medical condition in TV
ads, and whether they’ve looked for information on government websites. We chose not to ask
whether they’ve looked for information on manufacturer websites because we don’t want
respondents to confuse it with the option, “a prescription drug website.”

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Finally, three comments had suggestions for how we ask our questions. One comment
recommended reducing or eliminating the number of open-ended questions. The main survey
has only two questions with an open-ended option (allowing respondents to specify another
response). If pilot testing reveals potential closed-ended response options for these two
questions we will add them to the main survey. One comment suggested changing our scale for
how we measure exposure to prescription drug promotion. We changed this scale from
qualitative frequency to a yes/no scale. Similarly, one comment asked us to consider how we
measure how much of an ad respondents saw or read because there may be many variables that
affect this. We have chosen not to change this scale but will consider this point when
interpreting the data. One comment suggested that we randomize response order for the paperbased surveys. We plan to create multiple versions of the paper-based scale to account for
household sampling and viewing of the ad, so we are concerned that creating different versions
to account for response option randomization will be too complex for a survey of this scale.
However, we agree that response option order is important to take into account when interpreting
results.
Topic (4) – ways to minimize burden. One comment suggested we conduct the survey with an
online consumer survey panel to reduce time and costs and increase response rates. Although we
agree that online survey panels can be an efficient way to collect data, this survey is designed to
be nationally representative. Following OMB’s advice, therefore, we will use the Internet as one
mode of data collection but will not rely on an online survey panel for sampling
(https://www.whitehouse.gov/sites/default/files/omb/inforeg/pmc_survey_guidance_2006.pdf ).
External Reviewers
In addition to public comment, FDA sent materials and received comments from two individuals
for external peer review in 2016. These individuals are:
1. Dr. Fred Conrad, Research Professor, University of Michigan, [email protected]
2. Dr. Joel Weissman, Associate Professor, Harvard Medical School, [email protected]

9. Explanation of Any Payment or Gift to Respondents
We plan to recruit using two $1 bills ($2 total per sampled respondent) mailed in advance with
the initial invitation letter as a gesture to encourage response and maintain data quality. In the
second contact attempt, we will conduct an experiment to test whether a short statement
mentioning the previously paid incentive increases survey response, thereby testing whether
social exchange can be extended past the initial contact attempt. Half the sample will be
provided language that reminds them they received a cash incentive in the previous letter; the
remaining half will be reminded they received a letter but will not be specifically reminded about
the incentive.
Incentives are a commonly used technique to encourage participation and decrease non-response.
Scientific studies have consistently shown the inclusion of an incentive increases response rates,

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and that prepaid incentives are more effective than incentives that are contingent upon
completion of the survey (e.g., Refs. 5, 6). Shettle and Mooney (Ref. 7) concluded that
incentives in government surveys provide a “decided cost advantage” in improving response
rates, without negatively impacting non-response bias, data quality, or respondent good will.
Indeed, studies point to incentives improving data quality in terms of greater response
completeness, accuracy and reduced question item nonresponse, and more comments to openended questions (Refs. 8, 9, 10). Recent studies on the use of incentives (Refs. 11, 12)
demonstrate their continued effectiveness in increasing survey response, particularly pre-paid
cash incentives. Mercer, et al. (11) found that, “pre-paid incentives offered in mail surveys had
the largest per dollar impact on response” when compared with promised incentives and nonmail modes. Medway and Tourangeau (Ref. 13) found that offering an incentive led to a
significant reduction in item nonresponse.
While studies have shown that the marginal returns diminish as the pre-paid incentive amount
increases (Refs. 8, 14, 15), there is still no agreement on an “optimal” incentive amount. A $2
incentive amount was chosen based on past studies. For example, Shaw et al. (Ref. 14) found
that a $2 incentive with multiple mailings, when compared with a $5 incentive, was effective in
improving response rates in a cost-efficient fashion. Another study by Millar and Dillman (Ref.
16) found that a token cash incentive of $2 was effective in improving response rates in a mixed
mode survey. Based on these and similar findings (Ref. 17), we believe this amount is
reasonable for broad demographic recruitment, both in increasing response rate and timeliness of
response.
10. Assurance of Confidentiality Provided to Respondents
All participants will be provided with an assurance of privacy to the extent allowable by law (see
Appendix A).
All information that can identify individual respondents will be kept by the independent
contractor in a form that is separate from the data provided to FDA. For all data alphanumeric
codes will be used instead of names as identifiers. These identification codes (rather than names)
are used on any documents or files that contain study data or participant responses.
Electronic files will be kept on the contractor’s network, accessible only to project staff and
under password protection. Access to UNIX or network-based data files is controlled through
the use of Access Control Lists or directory- and file-access rights based on user account ID and
the associated user group designation, which is maintained by the system administrator. Upon
initiating a project, a project-specific directory is created for use by that project on networkresident disk storage media. Access rights to the data and applications stored within the
directory are granted only to users specifically authorized to access the project directory.
Access control on the PC is achieved by sound file management procedures by each user. Staff
are instructed on the proper use of PCs for the storage, transfer, and use of sensitive information
and the tools available, such as encryption, to better secure confidential data. All of the
contractor’s employees have taken and signed the Westat Confidentiality Pledge that assures
confidentiality of survey data.

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The contractor’s Computer Operations staff make a full disk backup of all host and server-based
storage once a week. The weekly backups are retained at an off-site location for 8 weeks. An
additional backup is generated every fourth week and retained for 1 year.
The contractor also makes a daily incremental backup for host and server-based storage. All disk
files that have been created or modified since the previous incremental backup are copied. The
incremental backups are retained for 8 weeks.
Backup tapes are stored in a specialized high-security, off-site facility under stringent
environmental and other data protection controls until they are scheduled to be recycled. Logs of
all backup tapes are maintained by a tape management system. To minimize the risk of exposure
of confidential information, all tapes are erased before being released to the scratch pool.
Confidentiality of the personally identifiable information submitted is protected from disclosure
by part 20 of the agency’s regulations (21 CFR part 20). These methods will be approved by
FDA’s Institutional Review Board (Research Involving Human Subjects Committee, RIHSC)
and Westat’s Institutional Review Board prior to collecting any information. All data will also be
maintained in consistency with the FDA Privacy Act System of Records #09-10-0009 (Special
Studies and Surveys on FDA Regulated Products).
11. Justification for Sensitive Questions
This data collection will not include sensitive questions. The complete list of questions is
available in Appendix A.
12. Estimates of Annualized Burden Hours and Costs
12a. FDA estimates the burden of this collection of information as follows:
Table 1.--Estimated Annual Reporting Burden1
Activity

No. of
Respondents

No. of
Responses per
Respondent

Total
Annual
Responses

Pilot Study
Survey invitation letter

100

1

100

Reminder postcard

100

1

100

Non-response letter

82

1

82

Non-response
questionnaire letter
Second postcard

81

1

81

60

1

60

6

Average
Burden per
Response

.08
(5 min.)
.03
(2 min.)
.08
(5 min.)
.08
(5 min.)
.03
(2 min.)

Total
Hours

8
3
7
7
2

Activity

No. of
Respondents

No. of
Responses per
Respondent

Survey

35

1

35

.33
(20 min.)

12

Main Study
Survey invitation letter

5,042

1

5,042

403

Reminder postcard

5,042

1

5,042

Non-response letter

4,173

1

4,173

Non-response
questionnaire letter
Second postcard

4,073

1

4,073

3,063

1

3,063

Survey

1,765

1

1,765

.08
(5 min.)
.03
(2 min.)
.08
(5 min.)
.08
(5 min.)
.03
(2 min.)
.33
(20 min.)

Total
1

Total
Annual
Responses

Average
Burden per
Response

Total
Hours

151
334
326
92
582
1927

There are no capital costs or operating and maintenance costs associated with this collection of information.

We estimate a 35 percent response rate, based on recent work on similar studies (Ref. 18). Prior
to the main study, a pilot study will be conducted to test the data collection process. We estimate
35 respondents will complete the pilot study and 1,765 will complete the main study (see table
1).
13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital Costs
There are no capital, start-up, operating or maintenance costs associated with this information
collection.
14. Annualized Cost to the Federal Government
The total estimated cost to the Federal Government for the collection of data is $562,415
($281,207.50 per year for two years). This includes the costs paid to the contractors to program
the study, draw the sample, collect the data, and create a database of the results ($531,215.00).
The contract was awarded as a result of competition. Specific cost information other than the
award amount is proprietary to the contractor and is not public information. The cost also
includes FDA staff time to design and manage the study, to analyze the data, and to draft a report
($31,200; five hours per week for two years).
15. Explanation for Program Changes or Adjustments
This is a new data collection.

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16. Plans for Tabulation and Publication and Project Time Schedule
Conventional statistical techniques for survey data, such as descriptive statistics, t-tests, chisquare tests, and regression models will be used to analyze the data. See Section B below for
detailed information. FDA anticipates disseminating the results of the study after the final
analyses of the data are completed, reviewed, and cleared. The exact timing and nature of any
such dissemination has not been determined, but may include presentations at trade and
academic conferences, publications, articles, and Internet posting.
Table 2. – Project Time Schedule
Task
Estimated Number of Weeks
after OMB Approval
Pilot study data collected
9 weeks
Main study data collected
25 weeks
Final methods report completed
35 weeks
Final results report completed
47 weeks
Manuscript submitted for internal review
60 weeks
Manuscript submitted for peer-review journal publication
70 weeks
17. Reason(s) Display of OMB Expiration Date is Inappropriate
No exemption is requested.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.
References
1. Aikin, K. J., J. L. Swasy, and A. C. Braman, "Patient and Physician Attitudes and Behaviors
Associated With DTC Promotion of Prescription Drugs--Summary of FDA Survey Research
Results” (2004).
(http://www.fda.gov/downloads/Drugs/ScienceResearch/ResearchAreas/DrugMarketingAdvertis
ingandCommunicationsResearch/ucm152860.pdf).
2. PhRMA Guiding Principles: Direct-to-Consumer Advertisements About Prescription
Medicines (2008).
(http://phrma.org/sites/default/files/pdf/phrmaguidingprinciplesdec08final.pdf).
3. STAT and Harvard T.H. Chan School of Public Health, “Americans’ Attitudes about
Changing Current Prescription Drug and Medical Device Regulation” (2016).
(https://cdn1.sph.harvard.edu/wp-content/uploads/sites/94/2016/05/STAT-Harvard-Poll-May2016-FDA-Regulation.pdf)

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4. Sullivan, H.W., and Campbell, M., “Do Prescription Drug Ads Tell Consumers Enough about
Benefits and Side Effects? Results from the Health Information National Trends Survey, Fourth
Administration” Journal of Health Communication 20(12), 1391-1396 (2015).
5. Prevention Magazine, “2012 DTC Survey: A New Era for DTC” Emmaus, PA: Rodale
(2012).
6. Church, A.H., “Estimating the Effect of Incentives on Mail Survey Response Rates: A MetaAnalysis” Public Opinion Quarterly 57, 62-79 (1993).
7. Petrolia, D.R. and S. Bhattacharjee, “Revisiting Incentive Effects: Evidence from a RandomSample Mail Survey on Consumer Preferences for Fuel Ethanol” Public Opinion Quarterly 73,
537-550 (2009).
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Statistics 15(2), 23-250 (1999).
9. James, J.M., and R. Bolstein, “The Effect of Monetary Incentives and Follow Up Mailings on
the Response Rate and Response Quality in Mail Surveys” Public Opinion Quarterly 54, 346–61
(1990).
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11. Willimack, D.K., H. Schuman, B. Pennell, and J.M. Lepkowski, “Effects of a Prepaid
Nonmonetary Incentive on Response Rates and Response Quality in a Face-to-Face Survey”
Public Opinion Quarterly 59 (1), 78-92 (1995).
12. Mercer, A., A. Caporaso, D. Candor, and R. Townsend, “Monetary Incentives and Response
Rates in Household Surveys” Public Opinion Quarterly 79, 105-12 (2015).
13. Singer, E., and C. Ye, “The Use and Effects of Incentives in Surveys” Annals of the
American Academy of Political and Social Science 645(1),112–141 (2013).
14. Medway, R.L. and R. Tourangeau, “Response Quality in Telephone Surveys: Do Prepaid
Cash Incentives Make a Difference” Public Opinion Quarterly 79, 524-543 (2015).
15. Shaw, M. J., T. J. Beebe, H. L. Jensen, and S. A. Adlis, "The Use of Monetary Incentives in
a Community Survey: Impact on Response Rates, Data Quality, and Cost," Health Services
Research 35, 1339-1346 (2001).
16. Teisl, M.F., B. Roe, and M. Vayda, “Incentive Effects on Response Rates, Data Quality, and
Survey Administration Costs” International Journal of Public Opinion Research 18 (3), 364-373
(2006).

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17. Millar, M. M. and D.A. Dillman, "Improving Response to Web and Mixed-Mode Surveys,"
Public Opinion Quarterly 1-21 (2011).
18. Newsome, J., K. Levin, P. Brick, B. Schafer, and M. Vigil, “Best Approaches to Mode
Order and Non-response Prompting in a Multi-mode Survey.” Presented at the 67th AAPOR
Conference, Orlando, FL (2012).
19. Montaquila, J. M., J. M. Brick, D. Williams, K. Kim, et al., "A Study of Two-Phase Mail
Survey Data Collection Methods” Journal of Survey Statistics and Methodology 1(1), 66-87
(2013).

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