Document ID: FDA-2010-N-0266-0007
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Study of Clinical Efficacy Information in Professional Labeling, etc.; Correction
Posted Date: 2010-12-23T05:00Z

[Federal Register Volume 75, Number 246 (Thursday, December 23, 2010)]
[Notices]
[Pages 80821-80823]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-32278]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0266]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Study of Clinical 
Efficacy Information in Professional Labeling and Direct-to-Consumer 
Print Advertisements for Prescription Drugs; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a notice 
that appeared in the Federal Register of December 3, 2010 (75 FR 
75477). The document announced a proposed collection of information 
that has been submitted to the Office of Management and Budget (OMB) 
for review and clearance under the Paperwork Reduction Act of 1995 (the 
PRA). The document was published with an error. FDA, upon further 
review, realized that 3 comments had been submitted in response to the 
60-day notice and the responses to those comments are included in this 
notice. This document corrects that error.

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, 
Elizabeth.Berbakos@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In FR Doc. 2010-30385, appearing on page 
75480, in the Federal Register of Friday, December 3, 2010, the 
following correction is made:
    On page 75480, in the third column, the last sentence in the sixth 
complete paragraph states that no comments were received on the 
paperwork burden for the 60-day notice that published in the Federal 
Register of June 16, 2010 (75 FR 34142). FDA is correcting that 
statement to read: Three comments were received that expressed support 
for the research and recommended minor improvements to the study. The 
responses to those comments are included in the following paragraphs.
    (Comment 1) Several of this comment's suggestions have already been 
incorporated into our study design. Specifically, we agree that the 
study design should include the variables of age, education, ethnicity, 
race, health literacy, and whether the respondent is currently being 
treated with a prescription drug, and have included them in the 
questionnaire. Also, we have contracted with an organization that 
produces realistic ads and stimuli to ensure that we will show 
respondents realistic materials.
    Another question from this comment was the presentation of our 
manipulations. To clarify, the specific format of the presentation will 
be text only. We are investigating the use of charts and other visuals 
in another study (FDA-2009-N-0263 (January 5, 2010), ``Presentation of 
Quantitative Effectiveness and Risk Information to Consumers in Direct-
to-Consumer (DTC) Broadcast and Print Advertisements for Prescription 
Drugs,'' OMB control number 0910-0663.) Because all of the respondents 
in the current study will see the information in the same format, this 
will not compromise our ability to answer the current research 
questions.
    The comment also recommends expanding the physician study to 
include all health care professionals who have the ability to prescribe 
(i.e., nurse practitioners and physician assistants). This is a good 
idea, but it changes our research question from how physicians use 
labels to how prescribers use labels. These groups vary in education 
and may vary in experience and training in how to interpret and use 
clinical trial data. Because we do not have a sample size that is large 
enough to analyze differences between these groups, we will limit the 
sample to physicians in this study.
    Finally, the comment recommends that FDA publish findings from the 
preliminary study related to the current project, ``Mental Models Study 
of Health Care Providers' Understanding of Prescription Drug 
Effectiveness'' (FDA-2008-N-0589; April 3, 2009). We agree

[[Page 80822]]

and have taken steps to publish this report on FDA's Division of Drug 
Marketing, Advertising, and Communications Web site: http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090276.htm.
    (Comment 2) This comment had several suggestions regarding the 
physician study. First, it recommended that we show physicians the 
Prescribing Information (PI) in a manner consistent with how physicians 
usually view sections of it, particularly since how each physician 
views the PI may be highly individualized. We agree. Because there is 
likely much variability in the way physicians view prescription drug 
information, we have designed this part of the study to examine 
specifically those habits. To do so, we will show physicians a 
highlights section that is hyperlinked to the more complete sections of 
the PI. We will record the order in which physicians access each 
section and how much time they spend there. This will provide us with 
information to gauge how physicians view the information in the PI, 
something that we currently have no data on.
    Second, this comment recommends that we show physicians final 
magazine ads rather than conceptual ads. We agree and, as discussed in 
the response to the previous comment, we have contracted with an 
organization that produces professional-quality ads.
    Third, this comment recommends increasing the sample size from 500 
to 800 individuals. We agree that a larger sample would be desirable, 
however, given resource constraints we are not able to increase the 
sample size. Moreover, we have conducted a power analysis and have 
determined that our current sample size is adequate to answer our 
research questions.
    Fourth, the comment recommends the removal of statements in the 
questionnaire that the drug is fictitious and instead label it a 
``potentially new drug.'' FDA had many internal discussions regarding 
this issue and decided that because of the particular sample, it is 
necessary to be upfront with them about the nature of the drug. 
Physicians will be more savvy about the particulars of the chemical 
entities and the realism of the clinical benefits and we do not wish to 
make them skeptical of our purposes. We agree that this approach is 
preferable for consumers and so we will inform them that this is a 
potentially new drug in that part of the study.
    Fifth, we agree that the characteristics of participants who are at 
risk and those who are or are not treating with a prescription drug may 
differ and we will include these variables in our analyses.
    Sixth, the comment recommends altering question 17 of the 
questionnaire to reflect the physicians' use of the DTC ad versus their 
guess as to the understandability of the ad for patients. We agree that 
we are asking physicians to estimate the level of understanding their 
patients have. These perceptions are of specific interest to us as they 
relate to physicians' perceptions of DTC advertising and of the 
presentation of information in the ads. Physicians who have been in 
practice for any length of time may have a sense of how their patients 
will understand materials. This is a question that we will also 
investigate in relation to the number of years physicians have been in 
practice.
    Seventh, the comment recommends that question 30 be split into two 
questions to separately assess the effect of DTC advertising on 
patients and the effect of DTC advertising on their practice. We agree 
and will make that change.
    This comment also had two suggestions for the consumer part of the 
study. First, the comment recommended against delivering this study on 
a handheld device, as the viewing of the ad may render the concept 
unclear. We agree and have struggled with this issue, but due to the 
constraints of the internet panel, we cannot specify the type of device 
on which participants must take the survey. We have included a question 
to assess this variable, and we will analyze it to determine if there 
are sizable differences based on viewing medium.
    Second, the comment recommends that the questionnaire avoid medical 
terminology and reference to the ``prescribing information.'' We have 
attempted to make the questionnaire clear for consumers and do not see 
the word ``prescribing information'' in the questionnaire. The 
questionnaire provided for comment includes programming notes that the 
respondent will not see.
    (Comment 3) First, this comment recommends evaluating the benefits 
and risks together and in a similar format so as not to bias the 
results. We agree that the benefits and risks should be evaluated 
together and have several measures to investigate both. We are keeping 
the risk information constant across all of our conditions specifically 
so as not to bias the results. Our research questions involve the 
conveyance of information about benefits. Because of the complexity of 
DTC ads, we cannot manipulate both benefits and risks at the same time. 
We are conducting other studies examining the presentation of risk 
information (For example, FDA-2010-N-0417 (August 26, 2010), 
``Experimental Study of Format Variations in the Brief Summary of 
Direct-to-Consumer Print Advertisements'') and collectively, this body 
of research will answer questions of benefit and risk presentation. To 
clarify, risk information will be presented similarly to how it is 
currently presented in DTC print ads.
    Second, the comment recommends the introduction of a control arm 
that is similar to what is currently being used in the marketplace. Our 
design includes control conditions that do not present placebo 
information. These ads will look identical to the ads for products that 
are currently on the market.
    Third, the comment questions the use of comparative benefit and 
comparative safety questions. We are using these measures for 
reliability as another way to assess consumers' perceived risk and 
benefits. As recommended in the comment, we are using them for 
informational purposes only and not as a specific, separate measure of 
comparative advertising.
    Fourth, the comment recognizes the complexity of the data that are 
available to be conveyed in DTC ads. We agree that there are a number 
of questions to be answered that cannot be addressed in the current 
study: E.g., variations in clinical study designs, instruments used, 
populations studied, and varying degrees of severity of illness. We 
cannot address all questions in one study and have chosen to focus on 
the issues of placebo and framing in a treatment and prevention 
approach. We hope that the results of this study will spur additional 
follow on studies conducted by FDA and others. Although the issue of 
different therapeutic areas is also relevant, and a study looking at 
the two ends of the disease-seriousness spectrum would be a great 
follow on, the basic concepts of information processing should not 
differ depending on drug class. Although we agree that replication is 
valuable and necessary, we do not believe that limiting the study to 
two therapeutic areas impugns the internal validity of the study.
    Fifth, the comment recommends wording changes to the question about 
taking the drug if the doctor prescribed it. Although we understand the 
rationale for changing this question, it is a measure of behavioral 
intention and as such, we wanted to have a more blunt measure of 
intention. It will not be used to assess doctor-patient interaction 
issues.
    Sixth, the comment questions the inclusion of physicians in the 
study, citing concerns that consumer responses

[[Page 80823]]

cannot be compared to physician responses and that this comparison is 
not relevant to the regulation of DTC advertisements. Indeed, the 
primary reason for conducting the study with physicians is to explore 
their processing of the prescribing information (PI), wholly separate 
from the consumer study. Nevertheless, since we have the two samples, 
we are conducting some exploratory analyses to compare the responses of 
consumers to information about a drug to the physicians' understanding 
of the drug. While this does have relevance to the regulation of DTC 
advertising (e.g., a DTC ad that features a presentation of information 
that brings consumers closer to the assessment of the physician will be 
preferred over that same ad with a presentation of information that 
moves them farther away), we are approaching this comparison as a 
first, exploratory attempt at this type of analysis.

    Dated: December 20, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-32278 Filed 12-22-10; 8:45 am]
BILLING CODE 4160-01-P