[Federal Register Volume 71, Number 79 (Tuesday, April 25, 2006)]
[Notices]
[Pages 23921-23924]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-6142]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0133]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Experimental Evaluation of Variations in Content and 
Format of the Brief Summary in Direct-to-Consumer Print Advertisements 
for Prescription Drugs

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on a 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, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on two studies of consumer 
evaluations of variations in content and format of the brief summary in 
direct-to-consumer (DTC) prescription drug print advertisements.

DATES: Submit written or electronic comments on the collection of 
information by June 26, 2006.

ADDRESSES: Submit electronic comments on the collection of

[[Page 23922]]

information to: http://www.fda.gov/dockets/ecomments. 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: Karen Nelson, Office Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1482.

SUPPLEMENTARY INFORMATION:

I. Backround

    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, including each 
proposed extension of an existing 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 each of 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 Evaluation of Variations in Content and Format of the 
Brief Summary in DTC Print Advertisements for Prescription Drugs

    Section 1701(a)(4) of the Public Health Service Act (42 U.S.C. 
300u(a)(4)) authorizes FDA to conduct research relating to health 
information. Section 903(b)(2)(c) of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 393(b)(2)(c)) authorizes FDA to 
conduct research relating to drugs and other FDA-regulated products in 
carrying out the provisions of the act. Under the act, a drug is 
misbranded if its labeling or advertising is false or misleading. In 
addition, section 502(n) of the act (21 U.S.C. 352(n)) specifies that 
advertisements 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 approved labeling. The 
regulation also specifies that the phrase ``side effect and 
contraindication'' refers to all of the categories of risk information 
required in the approved product labeling written for health 
professionals, including the warnings, precautions, and adverse 
reactions sections. Thus, every risk in an advertised drug's approved 
labeling must be included to meet these regulations.
    In recent years, FDA has become concerned about the adequacy of the 
brief summary in DTC print advertisements. Although advertising of 
prescription drugs was once primarily addressed to health 
professionals, increasingly consumers have become a target audience, as 
DTC advertising has dramatically increased in the past few years. 
Results of FDA's 2002 survey on DTC advertising (available at http://www.fda.gov/cder/ddmac/researchka.htm) show that 41 percent of 
respondents in 2002 reported they do not usually read any of the brief 
summary that accompanies the main print ad. Use of the brief summary 
was a function of whether they have an interest in the condition; about 
45 percent of those having a particular interest in the advertised drug 
read all or almost all of the brief summary. Despite their interest, 
about half of these individuals described the brief summary as somewhat 
or very hard to understand.
    Because the regulations do not specify how to include 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, or prescribing 
information). This labeling is written for health professionals, using 
medical terminology. FDA believes that while this is one reasonable way 
to fulfill the brief summary requirement for print advertisements 
directed toward health professionals, this method is difficult for 
consumers to understand and therefore may not be the best approach to 
communicate this important information to them.
    In 2004, FDA published a draft guidance entitled ``Brief Summary: 
Disclosing Risk Information in Consumer-Directed Print Advertisements'' 
(available at http://www.fda.gov/cder/guidance/5669dft.htm). This 
guidance outlined possible options for improving the communication of 
risk information to consumers in specific promotional pieces. When 
discussing the current professional prescribing information format, the 
guidance states that the ``volume of the material, coupled with the 
format in which it is presented... discourages its use and makes the 
information less comprehensible to consumers.'' The draft guidance 
suggested three possible presentations for the brief summary, including 
the current prescribing information format, an approved patient package 
insert, or highlights from the physician labeling rule.
    In the content study, FDA plans to investigate the role of context 
in providing useful risk information to consumers. It has been 
theorized that long lists of minor risks may detract from the 
understanding of more serious risks, as stated in the draft guidance. 
Nonetheless, if the risk information is presented with proper 
supporting context, people may find the information facilitates rather 
than distracts from the understanding of the risk information. One of 
the two proposed studies in this notice will investigate the context 
that may contribute to this facilitation.
    In addition to context, format also plays a role in the clarity and 
understanding of the brief summary. FDA proposes to collect information 
on the usefulness of different formats suggested in the draft guidance. 
In addition to the patient package insert, which is usually presented 
in a question and answer format, FDA proposes to test a consumer-
friendly highlights format, as well as a format based on the drug facts 
labeling used for over-the-counter drugs.
    Data from these two studies will converge to allow a better 
assessment of various ways to present risk information

[[Page 23923]]

in a print advertisement for a prescription drug.

II. Studies

A. Content Study

1. Design Overview
    This study will employ a between-subjects crossed factorial design 
using a mall-intercept protocol. Ten print advertisements will be 
created using two levels of drug side effect information and five 
levels of context. Thus, the factors will be the amount of side effect 
information (short; long) and amount of supportive context for the side 
effect information (paragraph only; paragraph rate; paragraph rate plus 
placebo rate; chart rate; chart rate plus placebo rate). Other 
information will be constant across conditions. Respondents who self-
identify as being in the target market for the condition will be asked 
to read a single print advertisement for a new prescription drug. After 
reading the advertisement, they will be asked questions about their 
comprehension and evaluation of the information presented in the 
advertisement.
2. Factors
    a. Participants. Consumers will be screened and recruited by the 
contractor to be self-identified as being moderately overweight or 
more. We chose to limit our investigation to this one disease condition 
(weight loss) because it has a high prevalence rate in the population 
(http://www.cdc.gov/nccdphp/dnpa/obesity/faq.htm) and is likely to 
occur both in males and females. We chose to accept this decrease in 
generalizability to maximize our ability to detect subtle differences 
in content variation. Participants will be screened to represent a 
range of education levels (some college or less; completed college or 
more). Because the task presumes basic reading abilities, all screened 
participants will speak English as their primary language and, as 
appropriate, have reading glasses available when participating in the 
study.
    b. Amount of side effect information. The number of side effects 
will be varied to create ``short'' and ``long'' levels as follows:
    Short: ``Side effects include a, b, and c. This is not a complete 
list. Talk to your doctor for more information.''
    Long: ``Side effects include a, b, c, d, e, f, g, and h. Talk to 
your doctor for more information.''
    c. Context. The context for the side effect information will be 
varied to create five levels ranging from least supportive to most 
supportive as follows:
    Paragraph only: Listing of side effects in paragraph form.
    Paragraph rate: Listing of side effects and their rate of 
occurrence in paragraph form.
    Paragraph rate plus placebo rate: Listing of side effects, their 
rate of occurrence, and the rate of placebo effects in paragraph form.
    Chart rate: Listing of side effects and their rate of occurrence in 
table form.
    Chart rate plus placebo rate: Listing of side effects, their rate 
of occurrence, and the rate of placebo effects in table form.
3. Procedure
    Participants will be shown one ad. Then a structured interview will 
be conducted with each participant to examine a number of important 
perceptions about the brief summary, including perceived riskiness of 
the drug, comprehension of information in the brief summary, and 
perceived usefulness of brief summary information. Finally, demographic 
and health care utilization information will be collected. Interviews 
are expected to last approximately 20 minutes. A total of 900 
participants will be involved. This will be a one-time (rather than 
annual) collection of information.

B. Format Study

1. Design Overview
    This study will employ a between-subjects crossed factorial design 
using a mall-intercept protocol. Three print advertisements will be 
created using three different formats: Question and answer, highlights 
(71 FR 3922, January 24, 2006), and drug facts (21 CFR 201.66 and 
Appendix A). The information in the formats will be constant across 
conditions. Participants who self-identify as being in the target 
market for the condition will be asked to read a single print 
advertisement for a new prescription drug. After reading the 
advertisement, they will be asked questions about their comprehension 
and evaluation of the information presented in the advertisement.
2. Factors
    a. Participants. Consumers will be screened and recruited by the 
contractor to be self-identified as being moderately overweight or 
more. As in the content study described previously in this document, we 
chose to limit our investigation to one disease condition-weight loss. 
Participants will be screened to represent a range of education levels 
(some college or less; completed college or more). Because the task 
presumes basic reading abilities, all screened participants will speak 
English as their primary language and, as appropriate, have reading 
glasses available when participating in the study.
    b. Type of format. The format of the information in the brief 
summary will be varied as follows: Question and answer, highlights, and 
drug facts. Please refer to Appendix A for examples of the different 
format variations.
3. Procedure
    Participants will be shown one ad. Then a structured interview will 
be conducted with each participant to examine a number of important 
perceptions about the brief summary, including perceived riskiness of 
the drug, comprehension of information in the brief summary, and 
perceived usefulness of brief summary information. Finally, demographic 
and health care utilization information will be collected. Interviews 
are expected to last approximately 20 minutes. A total of 300 
participants will be involved. This will be a one-time (rather than 
annual) collection of information.
    FDA estimates that 1,800 individuals will need to be screened to 
obtain a respondent sample of 900 for the content study and that 600 
individuals will need to be screened to obtain a respondent sample of 
300 for the format study. The screener is expected to take 30 seconds, 
for a total screener burden of 41 hours. The 1,200 respondents in the 
two studies will then be asked to respond to a series of questions 
about the advertisement. We estimate the response burden for each of 
the two studies to be 20 minutes, for a burden of 396 hours. The 
estimated total burden for this data collection effort is 437 hours. 
The respondent burden is listed in table 1 of this document.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 23924]]



                                 Table 1.--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                    Annual Frequency       Total Annual         Hours per
       No. of Respondents             per Response          Responses           Response          Total Hours
----------------------------------------------------------------------------------------------------------------
1,800 (content study: screener)                      1              1,800                .017                 31
----------------------------------------------------------------------------------------------------------------
900 (content study:                                  1                900                .33                 297
 questionnaire)
----------------------------------------------------------------------------------------------------------------
600 (format study: screener)                         1                600                .017                 10
----------------------------------------------------------------------------------------------------------------
300 (format study:                                   1                300                .33                  99
 questionnaire)
----------------------------------------------------------------------------------------------------------------
Total                                                                                                        437
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: April 18, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-6142 Filed 4-24-06; 8:45 am]
BILLING CODE 4160-01-S