[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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)
----------------------------------------------------------------------------------------------------------------
Efficacy Level
Information Type -------------------------------------------------------------------------------------------
Smallest Effect Smaller Effect Mid-Size Effect Larger Effect Largest Effect
----------------------------------------------------------------------------------------------------------------
Absolute Frequency 81% vs. 82% 61% vs. 82% 41% vs. 82% 21% vs. 82% 1% vs. 82%
----------------------------------------------------------------------------------------------------------------
Absolute Frequency + Fewer Fewer Fewer Fewer Fewer
Qualitative Label 81% vs. 82% 61% vs. 82% 41% vs. 82% 21% vs. 82% 1% vs. 82%
----------------------------------------------------------------------------------------------------------------
Absolute Difference Fewer (1%) Fewer (21%) Fewer (41%) Fewer (61%) Fewer (81%)
+ Qualitative Label
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
Activity Respondents per Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pretest 750 1 750 20 minutes 250
--------------------------------------------------------------------------------------------------------------------------------------------------------
Main Study 11,000 1 11,000 20 minutes 3,667
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 3,917
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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