[Federal Register Volume 74, Number 63 (Friday, April 3, 2009)]
[Notices]
[Pages 15293-15295]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-7471]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0589]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Mental Models Study 
of Health Care Providers' Understanding of Prescription Drug 
Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by May 4, 
2009.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-6974, or e-mailed to <a href="/cdn-cgi/l/email-protection#452a2c37241a363027282c36362c2a2b052a28276b202a356b222a33"><span class="__cf_email__" data-cfemail="402f2932211f3335222d293333292f2e002f2d226e252f306e272f36">[email protected]</span></a>. All 
comments should be identified with the OMB control number 0910-NEW and 
title ``Mental Models Study of Health Care Providers' Understanding of 
Prescription Drug Effectiveness.'' Also include the FDA 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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Mental Models Study of Health Care Providers' Understanding of 
Prescription Drug Effectiveness

    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.\1\ By its nature, the presentation 
of this risk information is likely to evoke active trade-offs by 
consumers and physicians, i.e., comparisons with the perceived risks of 
not taking a treatment, and comparisons with the perceived benefits of 
taking a treatment.\2\ The FDA has an interest in fostering safe and 
proper use of prescription drugs, which is an activity that 
necessitates understanding of both risks and benefits. Thus, an indepth 
understanding of physicians' processing of this information, their 
thinking on relevant topics, and their informational needs are central 
to this regulatory task.
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    \1\ 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)).
    \2\ See Swartz, L., Woloshin, S., Black, W., and Welch, H.G., 
``The role of numeracy in understanding the benefit of screening 
mammography,''Annals of Internal Medicine, 127(11), 966-72, 1997.
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    Under the act, FDA engages in a variety of communication activities 
to ensure that patients and health care providers have the information 
they need to make informed decisions about treatment options, including 
the use of prescription drugs. FDA regulations (21

[[Page 15294]]

CFR 201.57) describe the content of required product labeling, and FDA 
reviewers ensure that labeling contains accurate and complete 
information about the known risks and benefits of each drug.
    This proposed data collection will provide FDA with insight for 
evaluating and improving current communication procedures. It is 
designed to identify knowledge gaps for FDA to address, which would 
ultimately improve practitioner decisionmaking and hence the health 
outcomes of the affected patients. This new information collection uses 
``Mental Modeling,'' which is a qualitative research method that 
compares a model of the decisionmaking processes of a group or groups 
to a model of the same process developed from expert knowledge and 
experience. In this study, the decision models of health care providers 
concerning their understanding of drug product efficacy and how they 
communicate their understanding to their patients will be compared to a 
model derived from the knowledge and experience of experts who review 
product labeling for the purpose of ensuring that prescribers get the 
information they need to make optimal prescribing decisions. FDA will 
use telephone interviews to determine from the health care providers 
the factors that influence their understanding of drug product efficacy 
and how they communicate their understanding to their patients. 
Comparing expert and health care provider responses will allow for a 
richer understanding of decisions determining drug product efficacy 
from labeling and other sources and how this understanding is 
communicated to their patients.
    FDA regulations require that prescription drug advertisements that 
make (promotional) claims about a product also include risk information 
in a ``balanced'' manner (21 CFR 202.1(e)(5)(ii)), both in terms of the 
content and presentation of the information. This balance applies to 
both the front display page of an advertisement and the brief summary 
page. However, beyond the ``balance'' requirement there is limited 
guidance and research to direct or encourage sponsors to present 
benefit claims that are informative, specific, and reflect clinical 
effectiveness data.
    Research and guidance to sponsors on how to present benefit and 
efficacy information in prescription drug advertisements is limited. 
For example, ``benefit claims,'' broadly defined, appearing in 
advertisements are often presented in general language that does not 
inform patients of the likelihood of efficacy and are often simply 
variants of an ``intended use'' statement.\3\ In a study involving a 
content analysis of direct-to-consumer (DTC) advertising, the 
researchers classified the ``promotional techniques'' used in the 
advertisements. Emotional appeals were observed in 67 percent of the 
ads while vague and qualitative benefit terminology was found in 87 
percent of the ads. Only 9 percent contained data. However, for risk 
information, half the advertisements used data to describe side-
effects, typically with lists of side-effects that generally occurred 
infrequently.
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    \3\ Woloshin, S. and Schwartz, L., ``Direct to consumer 
advertisements for prescription drugs: what are Americans being 
told,'' Lancet, 358, 1141-46, 2001.
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    Additional research is necessary to uncover important information 
about how consumers understand effectiveness information about 
prescription drug products from DTC advertisements. This particular 
understanding is crucial to the risk-benefit tradeoff that patients 
must make with the consultation of a health care professional in order 
to achieve the best health outcomes. The qualitative information in 
this Mental Models phase of the research will provide a preliminary 
framework and help FDA craft subsequent quantitative studies.
    Overview. The proposed information collection will use ``mental 
modeling,'' a qualitative research method wherein the decisionmaking 
processes of a group of physician respondents concerning the 
effectiveness of various prescription drug products are modeled and 
compared to a model based on expert labeling knowledge and clinical 
experience in drug effectiveness. The information will be collected by 
telephone interviews concerning the factors that influence perceptions 
and decisions related to drug effectiveness. This method will help 
identify physicians' beliefs, priorities, informational needs, visions 
and conceptualizations about how well particular drugs work. A 
comparison between expert and physician models based on the collected 
information may identify ``consequential knowledge gaps'' that can be 
redressed through labeling changes as well as helping FDA focus future 
quantitative research on the communication of drug benefit information. 
Thus, the information to be collected will be used by FDA to develop 
and strengthen research materials and design in future planned 
quantitative experiments.
    The first step in the mental models process is to conduct 
background research to develop a model based on both experts' current 
knowledge and extant literature on drug effectiveness. The resulting 
``simple expert model'' is a mapping of decisionmaking factors, 
relationships and influences, and is used to develop an interview 
protocol for a day-long workshop with experts, hereafter referred to as 
the ``expert elicitation.''
    The expert elicitation was conducted November 28, 2007. It included 
nine experts from a variety of medical fields, including those versed 
in drug labeling issues and others with extensive clinical experience, 
particularly involving two medical conditions (insomnia, a medical 
condition frequently treated by general practitioners, and rheumatoid 
arthritis, a condition likely treated by specialists). Six experts were 
internal to FDA, two experts were from the National Institutes of 
Health, and one expert was external to the Federal Government, from the 
Association of Medical Colleges. The expert elicitation process does 
not solicit advice, opinions, or recommendations from the group, but 
instead tries to determine how each expert perceives the factors 
related to consumer decisionmaking, from their particular expert field. 
Results from the expert elicitation were used to develop the expert 
model, which generally includes adding new concepts and supporting 
details to the existing simple expert model. The new draft expert model 
was validated during a subsequent teleconference with the research team 
about a month following the initial elicitation. Following the 
validation, the project team finalized the expert model.
    The expert model informs the development of the physician interview 
guide for physician telephone interviews. Mental models research is 
typically conducted with cohorts of respondents who represent 
categories of people whose mental models are to be compared, both 
individually with the expert model and between cohorts, identifying the 
potential for significant differences among cohorts. Interviews will be 
conducted with 40 health care providers to develop a mental model 
describing how each of 2 cohorts learns about drug product efficacy and 
how their understanding about efficacy is communicated to their 
patients. The cohorts are as follows:
    (1) Primary care providers. This cohort includes office-based 
practitioners in primary care (general practice, family practice, and 
internal medicine) with at least 3 years of experience and who engage 
in patient care at least 50 percent of the time.

[[Page 15295]]

    (2) Specialists. This cohort includes office-based practitioners in 
rheumatology with at least 3 years of experience and who engage in 
patient care at least 50 percent of the time.
    Cohorts will be identified and recruited to represent a reasonable 
range of age, gender, and ethnicity.
    Within each cohort, 20 practitioners will be interviewed by trained 
interviewers in one-on-one in-depth telephone interviews. A sample size 
of 40 (approximately 20 primary care providers and 20 rheumatologists) 
is sufficiently large for the qualitative findings to capture a wide 
depth and range of people's thinking. The interviews will take 
approximately 45 minutes. The health care provider interviews will be 
used to create a mental model of physician decisionmaking factors with 
respect to drug product effectiveness.
    Potential physician participants will be randomly identified 
through a purchased list based on the American Medical Association's 
(AMA) Physician Masterfile. This list tracks all physicians, M.D. 
(doctor of medicine) and DO (doctor of osteopathic medicine), 
practicing in the United States, not only members of the AMA.
    FDA intends this collection to be used as formative research. As 
with our focus group research (OMB control number 0910-0360), the 
results of this formative research will provide direction toward 
potential areas of focus. Further research is necessary, and planned, 
to test concepts obtained from these results. This research will be 
useful in designing survey questions for the next phases of this 
research project (which will be submitted for approval at a later 
date).
    In the Federal Register of November 24, 2008 (73 FR 71006), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.

                                                      Table 1--Estimated Annual Reporting Burden\1\
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                                                           No. of        Annual Frequency  per      Total Annual        Hours Per
                   21 CFR Section                       Respondents             Response             Responses           Response         Total Hours
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21 U.S.C. 393(b)(2)(c) Questionnaire, Pretesting                     4                        1                  4                .75                  3
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21 U.S.C. 393(b)(2)(c) Questionnaire, Study                         40                        1                 40                .75                 30
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Total                                                .................  .......................  .................  .................                 33
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: March 27, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-7471 Filed 4-2-09; 8:45 am]
BILLING CODE 4160-01-S


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