Federal Register: June 22, 2009 (Volume 74, Number 118)
DOCID: fr22jn09-65 FR Doc E9-14501
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket ID: [Docket No. FDA-2009-N-0263]
NOTICE: NOTICES
DOCID: fr22jn09-65
DOCUMENT ACTION: Notice.
SUBJECT CATEGORY:
Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Presentation of Quantitative Effectiveness Information to Consumers in Direct-to-Consumer Television and Print Advertisements for Prescription Drugs
DATES: Submit written or electronic comments on the collection of information by [August 21, 2009
DOCUMENT 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 the Experimental Study of Presentation of Quantitative Effectiveness Information to Consumers in Directto Consumer (DTC) Television and Print Advertisements for Prescription Drugs. This study is designed to communicate quantitative information about product benefits in DTC print and television ads.
SUMMARY:
Agency Information Collection Activities; Proposals, Submissions, and Approvals
SUPPLEMENTAL 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 60day 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.
Experimental Study of Presentation of Quantitative Effectiveness
Information to Consumers in DirecttoConsumer (DTC) Television and Print Advertisements for Prescription DrugsNew
The Federal Food, Drug, and Cosmetic Act (the act) requires that
manufacturers, packers, and distributors (sponsors) who advertise
prescription human and animal drugs, including biological products for
humans, disclose in advertisements certain information about the
advertised product's uses and risks.\1\ By its nature, the presentation of
[[Page 29491]]
this information is likely to evoke active tradeoffs by consumers,
i.e., comparisons with the perceived risks of not taking treatment, and
comparisons with the perceived benefits of taking a treatment.\2\ FDA
has an interest in fostering safe and proper use of prescription drugs,
an activity that engages both risks and benefits. Therefore, an
examination of ways to improve consumers' understanding of this information is central to this regulatory task.
\1\ For prescription drugs and biologics, section 502 of the act
requires advertisements to contain ``information in brief summary
relating to side effects, contraindications, and effectiveness'' (21 U.S.C. 352(n)).
\2\ See Swartz, L., S. Woloshin, W. Black, et al., The Role of
Numeracy in Understanding the Benefit of Screening Mammography, Annals of Internal Medicine, 127(11), 96672, 1997.
Under the act, FDA engages in a variety of communication activities to ensure that patients and health care providers have the information they need to make informed decisions about treatment options, including the use of prescription drugs. FDA regulations (21 CFR 201.57) describe the content of required product labeling, and FDA reviewers ensure that labeling contains accurate and complete information about the known risks and benefits of each drug.
FDA regulations require that prescription drug advertisements that make (promotional) claims about a product also include risk information in a ``balanced'' manner (21 CFR 202.1(e)(5)(ii)), both in terms of the content and presentation of the information. This balance applies to both the front, display page of an advertisement, as well as including the brief summary page. However, beyond the ``balance'' requirement there is limited guidance and research to direct or encourage sponsors to present benefit claims that are informative, specific, and reflect clinical effectiveness data.
Research and guidance to sponsors on how to present benefit and
efficacy information in prescription drug advertisements is limited.
For example, ``benefit claims,'' broadly defined, appearing in
advertisements are often presented in general language that does not
inform patients of the likelihood of efficacy and are often simply
variants of an ``intended use'' statement. One content analysis of DTC
advertising by Woloshin and Schwartz (2001)\3\ found that information
about product benefits and risks is often presented in an unbalanced
fashion. The researchers classified the ``promotional techniques'' used
in the advertisements. Emotional appeals were observed in 67 percent of
the ads while vague and qualitative benefit terminology was found in 87
percent of the ads. Only 9 percent contained data. However, for risk
information, half the advertisements used data to describe side
effects, typically with lists of sideeffects that generally occurred
infrequently. Similarly, a content analysis by Frosch et al. (2007)\4\
found that only a small proportion of productclaim ads gave specific
information about the population prevalence of the medical condition
being advertised. The authors criticize DTC for presenting ``bestcase
scenarios that can distort and inflate consumers' expectations about
what prescription drugs can accomplish'' (Froch et al., 2007, p. 12)
without disclosing how many consumers are likely to experience that benefit.
\3\ Woloshin, S. and L. Schwartz, Direct to Consumer
Advertisements for Prescription Drugs: What Are Americans Being Told, Lancet, 358, 114146, 2001.
\4\ Frosch, D.L., P.M. Krueger, R.C. Hornik, et al., Creating
Demand for Prescription Drugs: A Content Analysis of Television
DirecttoConsumer Advertising, Annals of Family Medicine, 5(1), 6 13, 2007.
Some research has proposed that providing quantitative information
about product efficacy enables consumers to make better choices about
potential therapy. One possible format (termed the ``drug facts'' box
by its creators) for this information has recently received
attention.\5\ In these studies, the drug facts box format contained
information about the product's efficacy and safety in terms of rate
(how many people in the clinical trial experienced a benefit or side
effect compared to placebo). As expected, this study showed that
consumers who were provided efficacy information used it. Participants
receiving efficacy information (without other potentially valuable
information about the drug) were more likely to correctly choose the
product with the higher efficacy than consumers who saw the brief summary that did not contain this information.
\5\ Schwartz, L.M., S. Woloshin, H.G. Welch, The Drug Facts Box:
Providing Consumers With Simple Tabular Data on Drug Benefit and
Harm, Medical Decision Making, 27, 655692, 2007; Schwartz, L.M., S.
Woloshin, H.G. Welch, Communicating Drug Benefits and Harms With a
Drug Facts Box: Two Randomized Trials, Annals of Internal Medicine,
150, 516527, 2009; Woloshin, S., L.M. Schwartz, H.G. Welch, The
Value of Benefit Data in DirecttoConsumer Drug Ads, Health Affairs, Suppl Web Exclusives, W4234245, 2004.
Although these results are intriguing, additional research is necessary to uncover important information about how consumers understand effectiveness information about prescription drug products from DTC advertisements. For example, the research to date does not address whether simply adding efficacy rate information and qualitative summations to a consumerfriendly brief summary would enable consumers to find and report the correct answer, or if the presentation of information in a chart format itself increases comprehension.
Further, these data cannot address the best way in which to convey
numerical information; percents were used but another format, such as
frequencies, may be more effective at communicating quantitative
information. Previous research shows that individuals have great
difficulty processing numerical concepts (e.g., BeythMarom, 1982;
Bowman, 2002; Cohen, Ferrell, and Johnson, 2002).\6\ A few studies have
attempted to determine what different formats make these concepts least
troublesome (e.g., Fagerlin, Wang, and Ubel, 2005; Lipkus, 2007),\7\
however, most research into the communication of numerical concepts
concentrates on risk information. We are not aware of research looking
into the integration of quantitative information about effectiveness or
benefits into the body of the advertisement itself. The addition of
this information may help consumers make better healthcare decisions, provided they can understand it.
\6\ BeythMarom, R., How Probable is Probable? A Numerical Translation of Verbal Probability Expressions, Journal of
Forecasting, 1, 257269, 1982; Bowman, M.L., The Perfidity of
Percentiles, Archives of Clinical Neuropsychology, 17, 295303,
2002; Cohen, D.J., J.M. Ferrell, N. Johnson, What Very Small Numbers
Mean, Journal of Experimental Psychology: General, 131, 424442, 2002.
\7\ Fagerlin, A., C. Wang, P.A. Ubel, Reducing the Influence of
Anecdotal Reasoning on People's Health Care Decisions: Is a Picture
Worth a Thousand Statistics? Medical Decision Making, 25, 398405,
2005; Lipkus, I., Numeric, Verbal, and Visual Formats of Conveying
Health Risks: Suggested Best Practices and Future Recommendations, Medical Decision Making, 27, 697713, 2007.
It is also not known if ways of communicating product efficacy work equally well across print and television DTC media. To our knowledge, research on presenting quantitative information in risk communication has been conducted exclusively with static modalities. The ideal format for presenting quantitative information may vary as a function of presentation. The amount of mental processing capacity each individual can devote to understanding a message varies depending on how long individuals have to look at the material and whether the material is selfpaced or presented at an uncontrollable speed. As a result, some forms of quantitative information may lend themselves to print, rather than broadcast. This particular understanding is crucial to the risk benefit tradeoff that patients must make with the consultation of a health care professional in order to achieve the best health outcomes.
The proposed study will examine: (1) Various ways of communicating [[Page 29492]]
quantitative efficacy in DTC print ads and (2) whether the findings translate to DTC television ads.
Design Overview: This study will be conducted in two concurrent
parts; one examining quantitative information in DTC print
advertisements and the other examining such information in DTC
television advertisements. Three factors will be examined: Drug
efficacy, visual format, and type of statistic. Drug efficacy (low
versus high) is defined by a quantifiable, objective metric that can be
conveyed in graphical representations of the drug versus the comparator
reference drug (in this case, placebo). ``High'' efficacy is noticeably
better than the placebo, whereas ``low'' efficacy is minimally better
than the placebo. Visual format is defined as various methods through
which efficacy can be visually represented. We have chosen to
investigate three different formats: Bar graph, pictograph, and pie
chart. Type of statistic is defined as the type of statistical
information conveyed: Frequency, relative frequency, or percentage.
These factors will be combined in a partially crossed factorial design as follows:
Table 1.Type of Visual Format x Type of Statistic Conveyed x Efficacy Level
Type of Visual Format
Type of Statistic Efficacy Level None Pie Chart Bar Chart Pictograph
Frequency High Efficacy [check] [check] [check] [check]
Low Efficacy [check] [check] [check] [check]
Percentage High Efficacy [check] [check] [check] N/A
Low Efficacy [check] [check] [check] N/A
Combination Frequency + High Efficacy [check] N/A N/A N/A Percentage
Low Efficacy [check] N/A N/A N/A
Relative Frequency High Efficacy [check] N/A N/A N/A
Low Efficacy [check] N/A N/A N/A
Relative Frequency + Absolute High Efficacy [check] N/A N/A N/A Rate
Low Efficacy [check] N/A N/A N/A
None N/A [check] N/A N/A N/A
The test product will be for the treatment of high cholesterol and modeled on an actual drug used to treat that condition (such as Lipitor[sscopy]). The product labeling will be used as the reference for defining the high and lowefficacy levels and the objective metrics for clinical performances. Because both parts of the study will run concurrently, experimental conditions will be identical in both the print and television portions.
Participants will read or view one ad version. After reading the ad, participants will make a series of judgments about the drug. The mean difference between the low and highefficacy condition will serve as the baseline for testing whether this difference varies across various graphical presentations, with the exception of the No Information (control) condition. In other words, our analyses will involve two steps. In step 1, within each format, we will test whether participants were able to distinguish between low and highefficacy drugs. In step 2, within each efficacy level, we will test whether participants' estimates of efficacy differ across formats and examine the accuracy of these estimates.
Interviews are expected to last no more than 20 minutes. A total of 4,500 participants will be involved in the 2 parts of the study. This will be a one time (rather than annual) collection of information.
FDA estimates the burden of this collection of information as follows:
The total respondent sample for this data collection is 4,500 (2,225 in each part). We estimate the response burden to be 20 minutes, for a burden of 1,485 hours.
The response burden chart is listed in table 2 of this document.
Table 2.Estimated Annual Reporting Burden\1\
No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per Response Responses Response Total Hours
4,500 1 4,500 .33 1,485
Total 4,500 1 4,500 .33 1,485
\1\There are no capital costs or operating and maintenance costs associated with this collection of information. [[Page 29493]]
Dated: June 15, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E914501 Filed 61909; 8:45 am]
BILLING CODE 416001S
FOR FURTHER INFORMATION CONTACT
Liz Berbakos, Office of Information Management (HFA710), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 3017963792.