FR Doc E9-7471

[Federal Register: April 3, 2009 (Volume 74, Number 63)]
[Notices]
[Page 15293-15295]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03ap09-38]

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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 oira_submission@omb.eop.gov. 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