[Federal Register Volume 75, Number 168 (Tuesday, August 31, 2010)]
[Notices]
[Pages 53312-53314]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-21629]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0417]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Experimental Study of Format Variations in the Brief 
Summary of Direct-to-Consumer Print Advertisements

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 the Experimental Study of Format Variations 
in the Brief Summary of Direct-to-Consumer (DTC) Print Advertisements 
(ads). This study is designed to test different ways of presenting 
benefit and risk information in the brief summary in DTC print ads.

DATES:  Submit either electronic or written comments on the collection 
of information by November 1, 2010.

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:  Elizabeth Berbakos, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-3792, 
[email protected].

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.

[[Page 53313]]

    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 Format Variations in the Brief Summary of Direct-
to-Consumer Print Advertisements--New

    Section 502(n) of the Federal Food, Drug, and Cosmetic Act 
specifies that ads for prescription drugs and biological products must 
provide a true statement of information ``in brief summary'' about the 
advertised product's ``side effects, contraindications, and 
effectiveness.'' The prescription drug advertising regulations (Sec.  
202.1(e)(3)(iii) (21 CFR 202.1(e)(3)(iii))) specify that the 
information about risks must include each specific side effect and 
contraindication from the advertised drug's FDA-approved labeling, 
including the Warnings, Precautions, Adverse Reactions, and other 
relevant sections. Some of the current approaches to fulfilling the 
brief summary requirement, while adequate from a regulatory 
perspective, result in ads that may be difficult to read and understand 
when used in consumer-directed promotion.
    In recent years, FDA has become concerned about the adequacy of the 
brief summary in DTC print advertisements for prescription drugs. 
Because the regulations do not specify how to address each risk, 
sponsors can use discretion in fulfilling the brief summary requirement 
under Sec.  202.1(e)(3)(iii). Frequently, sponsors print in small type, 
verbatim, the risk-related sections of the approved product labeling 
(also called the package insert, professional labeling, prescribing 
information, and direction circular). This labeling is written for 
health professionals, using medical terminology. While adequate to 
fulfill the brief summary requirement for print advertisements, this 
method may not be the most ideal. Research has shown that while many 
consumers will make the effort to read the brief summary in 
prescription drug print advertisements if they are especially 
interested in the drug, as a general rule consumers typically read 
little or none of the brief summary information.\1\ Health 
practitioners themselves have indicated they often have difficulty 
finding information they actively seek in package inserts (see 65 FR 
80733 at 81082, December 22, 2000, for a discussion of studies 
supporting the use of a highlights section in physician labeling). 
There may be other ways to fulfill this requirement that improve 
consumers' ability to find and comprehend the information in this 
important document.
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    \1\ Aikin, K.J., Swasy, J.L. and Braman, A.C. (2004). Patient 
and Physician Attitudes and Behaviors Associated with DTC Promotion 
of Prescription Drugs: Summary of FDA Survey Research Results, Final 
Report. Available at http://www.fda.gov/cder/ddmac/Final%20Report/FRfinal111904.pdf. Last accessed March 26, 2009.
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    There is evidence suggesting that both information content and the 
format in which it is presented will impact comprehension. For 
instance, research with the format of over-the-counter (OTC) drug
(OTC) drug labels,\2\ the nutrition facts label,\3\ and other 
information formats\4\ demonstrates that information presented with 
section headings, graphics (such as bullets), and other design elements 
is more easily read than information presented in paragraph format.
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    \2\ Aikin, K.J. (1998). Consumer Comprehension and Preference 
for Variations in the Proposed Over-The-Counter Drug Labeling 
Format, Final Report; Vigilante, W.J. & Wogalter, M.S. (1997). The 
preferred order of overt-the-counter (OTC) pharmaceutical label 
components. Drug Information Journal, 31, 973-988.
    \3\ Levy, A.S., Fein, S.B. & Schucker, R.E. (1992). More 
effective nutrition label formats are not necessarily more 
preferred. Journal of the American Dietetic Association, 92(10), 
1230-1234.
    \4\ Lorch, R. & Lorch, E. (1995). Effects of organizational 
signals on text-processing strategies. Journal of Educational 
Psychology, 87(4), 537-544; Lorch, R. & Lorch, E. (1996). Effects of 
organizational signals on free recall of expository text. Journal of 
Educational Psychology, 88(1), 38-48; Lorch, R., Lorch, E. & Inman, 
W. (1993). Effects of signaling topic structure on text recall. 
Journal of Educational Psychology, 85(2), 281-290.
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    Research conducted by FDA and others has examined the content and 
format of the brief summary specifically. For instance, FDA conducted a 
series of relevant studies (OMB control numbers 0910-0591 and 0910-
0611). Schwartz, Woloshin, and Welch have compared one format for 
adding quantitative and qualitative benefit and risk information to the 
brief summary.\5\ Specifically, Schwartz et al. designed a prescription 
drug facts box similar in format to the Nutrition Facts panel and OTC 
Drug Facts panel. The box contains a number of elements, including 
qualitative and quantitative (both absolute frequency and absolute 
difference) information about benefits and risks. This study showed 
that consumers who were provided efficacy information in a prescription 
drug facts box were more likely to correctly choose the product with 
the higher efficacy than consumers who saw the brief summary using 
medical language from the prescribing information. However, it is 
unclear which elements of the drug facts box are necessary to improve 
consumer understanding. For instance, it is not known whether simply 
adding efficacy rate information to a consumer-friendly brief summary 
would be sufficient to enable consumers to understand a product's 
efficacy, or whether qualitative summations are necessary as well.
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    \5\ Schwartz, L.M., Woloshin, S., & Welch, H.G. (2009). 
Communicating drug benefits and harms with a drug facts box: Two 
randomized trials. Annals of Internal Medicine, 150(8). Available 
online at http://www.annals.org/cgi/content/full/0000605-200904210-00106v1. Last accessed March 26, 2009.
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    The current study will add to previous research by systematically 
examining these different elements to determine whether and how to add 
qualitative and quantitative benefit and risk information to the brief 
summary. The results of this study will inform FDA of the usefulness 
and parameters of various format and content options for the brief 
summary.
    Design Overview: This study will be conducted in two concurrent 
parts; one examining variations on the benefit information presented in 
DTC print advertisements and the other examining variations on the risk 
information presented in DTC print advertisements. The factors studied 
will be the type of information (i.e., the addition of quantitative and 
qualitative information in a box format) and the level of efficacy or 
risk. We will vary the level of efficacy and risk such that the largest 
effect is noticeably different from the placebo, whereas the smallest 
effect is minimally different from the placebo. These factors will be 
combined in a factorial design as follows:

[[Page 53314]]



                                      Table 1.--Proposed Design (4 x 5 + 2)
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                                                            Efficacy Level
  Information Type   -------------------------------------------------------------------------------------------
                       Smallest Effect     Smaller Effect    Mid-Size Effect    Larger Effect    Largest Effect
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Absolute Frequency    81% vs. 82%        61% vs. 82%        41% vs. 82%       21% vs. 82%       1% vs. 82%
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Absolute Frequency +  Fewer              Fewer              Fewer             Fewer             Fewer
 Qualitative Label    81% vs. 82%        61% vs. 82%        41% vs. 82%       21% vs. 82%       1% vs. 82%
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Absolute Difference   Fewer (1%)         Fewer (21%)        Fewer (41%)       Fewer (61%)       Fewer (81%)
 + Qualitative Label
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Absolute Frequency +  Fewer (1%)         Fewer (21%)        Fewer (41%)       Fewer (61%)       Fewer (81%)
Absolute Difference   81% vs. 82%        61% vs. 82%        41% vs. 82%       21% vs. 82%       1% vs. 82%
 + Qualitative Label
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Note. Two other cells will be tested: (1) No information and (2) Qualitative label only (fewer). This design (22
  cells) will also be used to test risk information (for a total of 44 cells). The specific numbers in the table
  are placeholders only. Qualitative label example: ``fewer people taking drug X had disease/symptom Y.''

    The test product will be for the treatment of 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. They will be randomly assigned to 
read one ad version. After reading the ad, participants will answer a 
series of questions about the drug. We will test how the information 
type affects perceived efficacy, perceived risk, behavioral intention, 
and accurate understanding of the benefit and risk information.
    Interviews are expected to last no more than 20 minutes. A total of 
11,750 participants will be involved in 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:

                                                     Table 2.--Estimated Annual Reporting Burden\1\
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                                                              No. of         Annual Frequency       Total Annual        Hours per
                       Activity                            Respondents         per Response          Responses           Response         Total Hours
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Pretest                                                               750                     1                750         20 minutes                250
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Main Study                                                         11,000                     1             11,000         20 minutes              3,667
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Total                                                                                                                                              3,917
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: August 25, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-21629 Filed 8-30-10; 8:45 am]
BILLING CODE 4160-01-S