[Federal Register Volume 73, Number 229 (Wednesday, November 26, 2008)]
[Notices]
[Pages 72058-72062]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-28065]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0595]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Experimental Study: Toll-Free Number for Consumer
Reporting of Drug Product Side Effects in Direct-to-Consumer Television
Advertisements for Prescription Drugs
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 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 a study examining the impact
on consumer comprehension of inclusion of a toll-free number to report
side effects in direct-to-consumer (DTC) prescription drug television
advertisements.
DATES: Submit written or electronic comments on the collection of
information by January 26, 2009.
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 (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-796-3792.
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, 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 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.
Toll-Free Number for Consumer Reporting of Drug Product Side Effects in
Direct-to-Consumer Television Advertisements for Prescription Drugs
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. For prescription drugs and
biologics, the act requires advertisements to contain ``information in
brief summary relating to side effects, contraindications, and
effectiveness'' (21 U.S.C. 352(n)). FDA is responsible for enforcing
the act and implementing regulations.
On September 27, 2007, the President signed into law the Food and
Drug Administration Amendments Act (FDAAA) (Public Law 110-85). Title
IX of FDAAA amends section 502(n) of the act (21 U.S.C. 352) by
requiring printed DTC advertisements for prescription drug products to
include the following statement printed in conspicuous text: ``You are
encouraged to report negative side effects of prescription drugs to the
FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.'' Title IX of
FDAAA also requires the Secretary of Health and Human Services (the
Secretary), in consultation with the Risk Communication Advisory
Committee (RCAC), to conduct a study not later than 6 months after the
date of enactment of FDAAA to determine if this statement is
appropriate for inclusion in DTC television advertisements for
prescription drug products. As part of this study, the Secretary shall
consider whether the information in the statement described previously
in this paragraph would
[[Page 72059]]
detract from the presentation of risk information in a DTC television
advertisement. If the Secretary determines that the inclusion of such a
statement would be appropriate for television advertisements, FDAAA
mandates the issuance of regulations implementing this requirement, and
for the regulations to reflect a reasonable length of time for
displaying the statement in television advertisements. Finally, FDAAA
requires the Secretary to report the study's findings and any
subsequent plans to issue regulations to Congress.
In accordance with the requirements of FDAAA, FDA convened a
meeting of the RCAC on May 15 and 16, 2008. A draft design for studying
this issue was proposed at that time and discussed by the Advisory
Committee. Based on comments received at that meeting, changes were
made to the proposed study design. The transcripts and materials from
that meeting can be found online at http://www.fda.gov/ohrms/dockets/ac/oc08.html#RCAC.
Relevant Prior History and Research
Section 17 of the Best Pharmaceuticals for Children Act (the BPCA)
(Public Law 107-109, January 4, 2002) required FDA to issue a final
rule mandating the addition of a statement to the labeling of each drug
product for which an application is approved under section 505 of the
act (21 U.S.C. 355). Under the BPCA, the statements must include: (1) A
toll-free number maintained by FDA for the purpose of receiving reports
of adverse events regarding drugs; and (2) a statement that the number
is to be used only for reporting purposes, and it should not be used to
seek or obtain medical advice (the side effects statement).
On April 22, 2004, FDA published a proposed rule with a proposed
side effects statement for certain prescription drug product labeling
and a proposed side effects statement for certain over-the-counter drug
product labeling (69 FR 21778). In the proposed rule, FDA solicited
comments on a proposed statement that FDA believed comported with the
previously mentioned mandate in the BPCA. The agency received 12
comments suggesting changes to the specific wording proposed. The
agency also received several comments suggesting that FDA engage in
research to study the wording of the proposed side effects statement
with consumers. Among the reasons cited for testing the statement were
to: (1) Determine the best and most precise wording for the statement,
(2) evaluate consumer comprehension of the proposed statement, and (3)
address concerns that consumers who read the statement will mistakenly
call FDA in search of medical advice rather than seeking appropriate
medical treatment. In addition, during the clearance process for the
proposed rule, both the Office of Information and Regulatory Affairs of
OMB and the Office of the Assistant Secretary for Planning and
Evaluation of the Department of Health and Human Services suggested
that FDA conduct focus groups or other consumer studies to inform the
wording of the side effects statement.
During the spring of 2006, to assist in developing this study, FDA
conducted two focus groups to gauge consumer understanding and
preferences for a number of proposed side effects statements and to
narrow the number of statements to be tested in subsequent experimental
research. In addition to the information collected on which versions of
the statements participants preferred, discussions showed that people
varied in their understanding of when to call FDA or their health care
practitioners and that some people would not call FDA even if they
experienced a serious side effect. Several people in the focus groups
suggested the addition of a Web site to report adverse side effects.
Based on the findings from the focus groups, nine statements were
selected for quantitative testing. A labeling comprehension experiment
was conducted with 1,674 men and women ranging in age from 21 to 95
with varying levels of education (OMB Control No. 0910-0497). The
results from that quantitative test found that only one of the versions
tested was rated as significantly less clear than the others, which
were all rated as generally clear and understandable. The results also
showed that participants reported they would not call FDA seeking
medical advice. Further, among those participants who said they would
call the FDA, the majority indicated they would call their doctor for
medical advice, rather than FDA, regardless of the severity of the side
effect. Finally, participants indicated they could distinguish between
serious and non-serious side effects, reporting that they would seek
emergency medical care in the case of serious side effects. The report
of the study is available in the docket for the final rule, Docket No.
FDA-2003-N-0313. The final rule, Toll-Free Number for Reporting Adverse
Events on Labeling for Human Drug Products (TFNR) (73 FR 63886, October
28, 2008), is available online at http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-25670.pdf.
Proposed Research
This study will examine the placement of the toll-free statement
and the length of time the statement is presented on-screen in a DTC
television advertisement for a prescription drug. The primary dependent
measure of interest is consumer comprehension of the risk information
in the advertisement. This study will also examine potential
differences in comprehension based on the wording of the toll-free
statement and the prominence of the statement.
The application of a new piece of information for viewers of DTC
ads presents logistical challenges. From a research perspective, the
primary issue under investigation is how to impart additional
information without increasing ``cognitive load,'' thus leading to
information overload. Cognitive load is an index of the memory demands
necessary to process a set of information. As cognitive load increases,
more mental resources are necessary to process and understand the
information.\1\ DTC ads are already quite dense when compared to ads
for other products. The risk information in the major statement of the
ad should not be compromised by the addition of the toll-free
statement. At the same time, it is preferable that the risk information
and the toll-free statement information are presented in such a way
that both are understandable. We have chosen a set of variables in the
current study to investigate issues of cognitive load. They are
described briefly in the following paragraphs before examining the
details of the research design.
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\1\ Chandler, P. and J. Sweller, ``Cognitive Load Theory and the
Format of Instruction.'' Cognition and Instruction, 8(4), 293-332,
1991.
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1. Placement
The location of the toll-free statement may facilitate or detract
from the risk information in the major statement. We have chosen three
locations for this information to test which location results in the
greatest communication of the risks of the drug and the concept that
side effects can be reported. It is possible that locating the toll-
free statement before the major statement provides a ``prime'' for the
risk information that follows; that is, the mention of side effects in
the toll-free statement will cause consumers to start thinking about
side effect-related information, which facilitates comprehension of the
risk information that follows. In this case, the two conceptual pieces
of information may flow together easily. Conversely, it is possible
that locating the toll-free statement here confuses consumers or
provides no information for them
[[Page 72060]]
because they have not yet heard any risk information. Thus, without
context, the statement lacks applicability.
Placing the toll-free statement during the major statement likely
reduces the comprehension of the risk information for the drug because
it divides viewer's attention between two competing pieces of
information. It is possible, however, that the juxtaposition of these
two informational concepts are complimentary and therefore do not
conflict.
The toll-free statement may serve the best role if it is located
after the risk information has been presented. In this case,
participants have been told about the risks and side effects of the
drug before they are told they may report this information. This
essentially primes the toll-free statement with the major statement. We
do not expect this placement to interfere with the comprehension of
risk information, as it is not present during the voicing of risks and
has not been introduced to viewers at this point. The usefulness of the
toll-free statement, however, may improve in this condition relative to
those discussed above because viewers have been provided with context.
Over time, it is likely that the toll-free statement will become
part of the background of the ads as people become accustomed to seeing
this statement in all DTC ads. In this respect, people will have the
statement as an option if needed but will be able to disregard it to
focus on the risk information when desired. Thus, we are testing a
condition in which the toll-free statement will be present during the
entire ad. This test condition will control for the effect of novelty
arising from the fact that consumers have not previously seen this type
of statement in TV ads. Presence of the statement during the entire ad
may increase noticeability of the toll-free statement initially, but
will be unlikely to interfere with risk information in the long run.
2. Statement Wording
The second variable, statement type, will have two executions of
statement language: The language from FDAAA versus the language used in
the TFNR and previously tested by FDA. The wording from these two
statements is as follows:
``You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-
800-FDA-1088.'' (FDAAA)
``Call your doctor for medical advice about side effects.
You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.'' (TFNR)
We think it is important to test both the toll-free statement
version in FDAAA and the version that we have previously tested with
actual consumers. The most obvious reason for this is to make sure that
the statement is maximally readable and understandable. It may be
valuable, however, to test two statements for another reason.
If the toll-free statement is enacted in broadcast ads, it is
possible that because of the boilerplate language, some amount of
``burnout'' will occur. That is, after viewers have seen the same
language in multiple ads for multiple products, they may ``tune out''
and not pay attention to the toll-free statement at all. If we test two
versions of the statement and find both acceptable, it would be
possible to either allow sponsors to choose one statement versus
another or to suggest some alternating of the two statements. This is a
long-term idea, however, and finding appropriate wording is the primary
goal of investigating this variable.
3. Duration
Congress specifically mandates that we investigate the duration of
the display of the toll-free statement. As with placement, the length
of time the toll-free statement is presented on-screen may influence
the cognitive load in the ad. For experimental control, we will look at
the duration of the statement while holding placement in the ad (after
the major statement of risks) constant. Although this placement should
not interfere with the processing of the risk information, it is
possible that the duration influences the take away message from the
ad. For example, having the statement on for a short amount of time may
not give consumers enough time to read and process the message,
resulting in lower comprehension of the message but no impact on the
comprehension of the risk information. Alternatively, displaying the
toll-free statement for a longer period of time may wipe away memory
traces of the risks from the major statement, resulting in lower risk
comprehension. Whether this longer duration increases the usefulness of
the toll-free statement itself is an empirical question. We will
compare these short and long durations to instances where the toll-free
statement is present during the entire ad and where there is no toll-
free statement at all.
4. Prominence
In addition to superimposing the toll-free statement on the screen
during the ad, there are other methods available to increase the
prominence of the statement. In particular, having the statement read
aloud in the ad voiceover while the statement is on the screen may be
considered particularly prominent. Does the additional prominence of
the statement compromise the comprehension of the risk information in
the major statement? If not, does the additional prominence result in a
greater understanding of the toll-free statement itself? It is likely
that there is a tradeoff between the gains of emphasizing the toll-free
statement and the comprehension of the risk information, given the
limited cognitive capacity of viewers. In examining this variable, we
are exploring the parameters of this tradeoff.
Design Overview
The design will consist of three parts. Part one will be a between-
subjects factorial design examining the placement of the toll-free
statement by the type of statement. The first variable, placement, will
have four levels: (1) Before the major statement of risks, (2) during
the major statement of risks, (3) after the major statement of risks,
or (4) continuously throughout the whole ad.
In each condition the toll-free statement will appear in the ad as
superimposed text at the bottom of the screen. We will also include a
control condition in which the statement does not appear.
Part One: Placement by Statement Type
4 x 2 + 1
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Statement Type
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Placement FDAAA TFNR
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Before major statement of .................... ....................
risks
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During major statement of .................... ....................
risks
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[[Page 72061]]
After major statement of .................... ....................
risks
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During the whole ad .................... ....................
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Plus:
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Control (no toll-free statement)
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Part two of the study will examine four variations in the duration
of the toll-free statement using the language from FDAAA: (1) Short
(approximately 3 seconds after the major statement), (2) long
(approximately 6 seconds after the major statement), (3) during the
whole ad, and (4) the control condition of no toll-free statement
included. These times were adopted by calculating how long it would
take a person reading at an average reading speed to read the
statement. As in the first part of this study series, the toll-free
statement will appear as superimposed text and a control condition in
which the toll-free statement does not appear will be included.
Part Two: Duration\*\
4 x 1
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Short (Approximately 3 seconds)
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Long (Approximately 6 seconds)
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During the whole ad
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Control (no toll-free statement)
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\*\Using FDAAA statement
Part three of the study will examine two variations in the
prominence of the toll-free statement using the language from FDAAA:
Spoken with only the Web site and telephone number in superimposed
text; or spoken with the full statement superimposed in text. Both
variants in part three will place the toll-free statement after the
major statement of risks. There will also be a control condition in
which the statement does not appear at all.
Part Three: Prominence\*\
3 x 1
Audio Only (spoken after major statement of risks, website and phone
number on screen)
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Extra Prominent (spoken after major statement of risks, entire toll-free
statement on screen)
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Control (no toll-free statement)
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\*\Using FDAAA statement
We will investigate these issues in one disease condition, high
blood pressure, because high blood pressure has a high incidence rate
in the population, is a public health concern, and is likely to occur
in both males and females. Further, because there is little promotion
for prescription treatment of high blood pressure, participants should
be less familiar with DTC television ads for this type of drug,
reducing the potential influence of prior experience.
Our primary dependent variable is comprehension of the risk
information mentioned in the major statement. In addition to this
variable, we will also examine comprehension of benefit information. We
will also examine the noticeability and comprehension of the toll-free
statement.
Procedure
Participants will see an advertising pod of four ads: Two non-DTC
ads (fillers), a DTC ad for a fictitious high blood pressure
medication, and a DTC ad for an unrelated medical condition with the
same toll-free statement included. We include two DTC ads with the
toll-free statement in our protocol because this better approximates
what will happen if this statement is required to be implemented in DTC
TV ads. That
[[Page 72062]]
is, viewers will see the statement in all DTC ads for all products. In
this study, we want to avoid the suggestion that there is something
particular about the high blood pressure drug class that causes the
statement to be mandated. Thus, we will show multiple DTC ads but ask
questions regarding only the ad which has been manipulated to test our
hypotheses. To maximize response information, the test ad will always
be the last ad participants see.
After viewing the ads, a structured interview will be conducted.
Participants will answer questions about the high blood pressure DTC
test ad they have seen. Questions will examine a number of important
perceptions about the advertised product, including risk comprehension,
risk recall, benefit comprehension, benefit recall, behavioral
intention, noticeability of the toll-free statement, and comprehension
of the toll-free statement.
Finally, demographic and health care utilization information will
be collected. The entire procedure is expected to last approximately 15
minutes. A total of 1,600 interviews will be completed. This will be a
one-time (rather than annual) information collection.
Participants
Data will be collected using an Internet protocol. Consumers over
the age of 18 will be screened and recruited by the contractor to
represent a range of education levels. Because the task presumes basic
reading abilities, all selected participants must speak English as
their primary language.
FDA proposes to conduct 2 rounds of pretesting with 200 consumers
in each round to refine the questionnaire and the stimuli before
fielding the main study.
FDA estimates the burden of this collection of information as
follows:
FDA estimates that 2,400 individuals will need to be screened to
obtain a respondent sample of 400 for the pretests and 1,600 for the
study. The screener is expected to take 30 seconds, for a total
screener burden of 20 hours. The ad viewing and questionnaire are
expected to take 15 minutes for the participants in the pretest and the
main study, for a cumulative study burden of 500 hours. The estimated
total burden for this data collection effort is 520 hours. The
respondent burden is provided in table 1 of this document:
Table 1--Estimated Annual Reporting Burden \1\
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Annual Frequency Total Annual Hours per
No. of Respondents per Response Responses Response Total Hours
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2,400 (screener) 1 2,400 .008 20
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400 (pretest) 1 400 .25 100
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1,600 (study) 1 1,600 .25 400
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Total 520
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations.gov.
Dated: November 19, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-28065 Filed 11-25-08; 8:45 am]
BILLING CODE 4160-01-S