Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Healthcare Professional Survey of Prescription Drug Promotion, 61761-61767 [2012-24973]
Download as PDF
<![CDATA[
Federal Register / Vol. 77, No. 197 / Thursday, October 11, 2012 / Notices
studies and provides associated
technical advice in the areas of study
design, sampling, and the collection,
management, analysis, and
interpretation of injury data; (4)
coordinates, manages, maintains and
provides tabulations and maps from
national surveillance systems and other
data sources that contain national, state
and local data on injury morbidity,
mortality and economic costs; (5)
prepares and produces high quality
statistical, economic and policy reports
and publications material for
information presentation and
dissemination by NCIPC staff; (6)
advises the Office of the Director,
NCIPC, in the area of data and systems
management and on surveillance and
statistical analysis issues relevant to
injury program planning and evaluation;
and (7) carries out functions listed in
numbers (1) to (6) to collaborate with
other Divisions/Offices in NCIPC, CDC
C/I/Os, PHS agencies, other federal
departments and agencies, and private
organizations as appropriate.
Practice Integration and Evaluation
Branch (CUHFC). (1) Monitors and
evaluates programs and policies and
disseminates findings to promote
program accountability and program
improvement; (2) promotes an enhanced
and sustained infrastructure for a public
health approach to injury and violence
prevention at state, local and tribal
levels; (3) generates and moves practice
based knowledge into program practice
and research fields; (4) provides
expertise in science based public health
practice, state-level injury surveillance,
and evaluation to state and local health
departments; and (5) collaborates with
NCIPC OD offices, Division of
Community Safety and Trauma
Systems, and the Division of Violence
Prevention on cross-cutting injury and
violence prevention programs, policies,
state-level surveillance, and evaluation.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
American Programs Act of 1974 (NAPA), 42
U.S.C. 2991b.
Administration for Children and
Families
Lillian A. Sparks,
Commissioner, Administration for Native
Americans.
[FR Doc. 2012–25018 Filed 10–10–12; 8:45 am]
[CFDA Number: 93.612]
BILLING CODE 4184–34–P
Announcement of the Award of a
Single-Source Grant to the Native
American Fatherhood and Families
Association (NAFFA) in Mesa, AZ
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Community Living
Administration for Native
Americans, ACF, HHS.
AGENCY:
Delegation of Authority
DATES:
Notice is hereby given that I have
delegated to the Administrator,
Administration for Community Living
(ACL), the authority vested in the
Secretary to execute the competitive
grant program under Section 1110 of the
Social Security Act, 42 U.S.C. 1310, as
appropriate. This authority may be redelegated.
This delegation does not supersede
previous delegations of the authority
contained herein, including the
delegation to the Administrator, Centers
for Medicare & Medicaid Services,
‘‘Delegation of Authority Under Title XI
of the Social Security Act, as
Amended,’’ dated March 4, 2011.
This delegation excludes the authority
to issue regulations, to establish
advisory committees and councils and
appoint their members, and to submit
reports to Congress and shall be
exercised in accordance with the
Department’s applicable policies,
procedures, and guidelines. I hereby
affirm and ratify any actions taken by
the Administrator, or his or her
subordinates, involving the exercise of
these authorities prior to the effective
date of this delegation. This delegation
is effective upon date of signature.
FOR FURTHER INFORMATION CONTACT:
Dated: October 3, 2012.
Kathleen Sebelius,
Secretary.
Announcement of the award of
a single-source grant to Native American
Fatherhood and Families Association
(NAFFA) in Mesa, AZ, to support
activities promoting Responsible
Fatherhood in Native American
communities.
ACTION:
The Administration for
Children and Families (ACF),
Administration for Native Americans
(ANA) announces the award of a
cooperative agreement in the amount of
$250,000 to the Native American
Fatherhood and Families Association
(NAFFA) in Mesa, AZ to conduct a
national outreach campaign focused on
promoting the importance of fatherhood
in Native communities. Included in the
national outreach campaign will be a
national conference, regional
workshops, webinars, and a Native
American Responsible Fatherhood Day
that will be promoted and implemented
throughout Native American
communities during the month of June
2013. The award will be made under
ANA’s program for Social and Economic
Development Strategies.
SUMMARY:
The award will be issued for the
time period of September 30, 2012 to
September 29, 2013.
Carmelia Strickland, Director, Division
of Program Operations, Administration
for Native Americans, 370 L’Enfant
Promenade SW., Washington, DC 20047.
Telephone: 877–922–9262; Email:
Carmelia.strickland@acf.hhs.gov.
[FR Doc. 2012–25013 Filed 10–10–12; 8:45 am]
NAFFA,
located in Mesa, Arizona, is a Native
non-profit organization whose mission
is to strengthen Native Families by
responsibly involving fathers in the
lives of their children, families, and
communities and partnering with
mothers to provide happy and safe
families.
Food and Drug Administration
Statutory Authority: This program is
authorized under § 803(a) of the Native
Dated September 25, 2012.
Sherri A. Berger,
Chief Operating Officer, Centers for Disease
Control and Prevention.
AGENCY:
[FR Doc. 2012–24771 Filed 10–10–12; 8:45 am]
SUPPLEMENTARY INFORMATION:
BILLING CODE 4160–18–M
pmangrum on DSK3VPTVN1PROD with NOTICES
61761
VerDate Mar<15>2010
14:03 Oct 10, 2012
Jkt 229001
PO 00000
Frm 00026
Fmt 4703
Sfmt 4703
BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2012–N–0018]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Healthcare
Professional Survey of Prescription
Drug Promotion
Food and Drug Administration,
HHS.
E:\FR\FM\11OCN1.SGM
11OCN1
61762
ACTION:
Federal Register / Vol. 77, No. 197 / Thursday, October 11, 2012 / Notices
Notice.
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 November
13, 2012.
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–
395–7285, or emailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–New and
title, ‘‘Healthcare Professional Survey of
Prescription Drug Promotion.’’ Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, Daniel.Gittleson@fda.hhs.gov.
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.
pmangrum on DSK3VPTVN1PROD with NOTICES
SUMMARY:
Healthcare Professional Survey of
Prescription Drug Promotion (0910–
New)
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(d)(2)(c) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 393(d)(2)(c)) authorizes FDA to
conduct research relating to drugs and
other FDA regulated products in
carrying out the provisions of the FD&C
Act.
The pharmaceutical industry spends
millions of dollars a year promoting
their products to American healthcare
professionals and to consumers. FDA
regulates the promotion of prescription
drugs to both professionals and
consumers. As such, FDA has an
interest in determining the attitudes,
perceptions, and opinions of healthcare
professionals with prescribing authority
regarding such promotion. Direct to
consumer (DTC) advertising captures
the most public attention, making it an
important topic of interest to FDA, but
the bulk of industry resources are spent
VerDate Mar<15>2010
14:03 Oct 10, 2012
Jkt 229001
in professional promotion, making this
an equally important topic for
investigation. The current research is
designed to explore prescriber opinions
of professional and DTC advertising and
promotion as well as other aspects of
prescriber experience that relate to the
promotion of prescription drugs.
The rise of DTC drug advertising and
prescription drug promotion has
affected healthcare professionals in a
number of ways. First, healthcare
professionals regularly encounter
patients who have been exposed to DTC
ads. Second, healthcare professionals
also see and hear such ads directly as
mass media consumers themselves.
Since clarification of the adequate
provision requirement for prescription
drug broadcast ads in 1997, FDA has
faced numerous questions about the
influence of DTC pharmaceutical
marketing because such advertising
directly engages consumers and
potentially affects interactions between
patients and their physicians (Refs. 1
and 2). Those questions have grown
more urgent with the growth of DTC in
recent years (Refs. 3 and 4). In 2002,
FDA considered this form of promotion
sufficiently important as a force in the
physician-patient interaction that they
surveyed both patients and physicians
regarding their perceptions of DTC (Ref.
5). Now, nearly a decade later, there are
critical reasons to return to the field to
gather more evidence on the influence
of DTC in the examination room and on
the relationships between healthcare
professionals and patients.
One of the most noteworthy aspects of
the current healthcare environment in
2012 is the role now played by various
physician extenders. Naylor and
Kurtzman (Ref. 6) recently noted that
nurses are the single largest group of
healthcare professionals in the United
States and they argue that nurse
practitioners will play an increasingly
vital role in primary care delivery.
Similarly, physician assistants also
bolster the ability of our healthcare
system to offer some types of care at
lower cost. The aforementioned 2002
FDA study did not include nurse
practitioners or physician assistants in
the sample; that study focused on
general practitioners and specialists in
several key areas targeted by DTC.
Murray and colleagues (Ref. 7) also
conducted a large-scale survey of U.S.
physicians regarding their perceptions
of DTC, but they also did not include
nurse practitioners or physician
assistants in their sample. Because DTC
likely affects daily interactions between
patients and nurse practitioners and
physician assistants—similar to the
2002 FDA study that suggested the
PO 00000
Frm 00027
Fmt 4703
Sfmt 4703
influence of advertising on physicians’
work lives—including these groups in
the new sample will further
understanding of DTC in the healthcare
system.
Another limitation of the 2002 FDA
study was the extent to which the
results were nationally representative.
As FDA has acknowledged, the initial
set of results as reported were
applicable to survey respondents but
were not weighted to reflect national
statistics as to the age, sex, and racial
composition of the healthcare
professional population. Similar to
many types of surveys that have
struggled in recent decades with
declines in cooperation rates (Ref. 8),
surveys of healthcare professionals in
general often can benefit from weighting
to reduce nonresponse bias. The current
survey will include weighted responses
from respondents that will reflect
national demographic patterns.
Over the past decade, researchers
have been able to better assess how DTC
has unfolded in the United States and
determine the questions that warrant
further survey work. For example,
researchers have worried for a number
of years that DTC might produce
adverse outcomes, such as clinically
inappropriate patient requests for drugs
or patient overestimation of the efficacy
of advertised medications (Refs. 5, 7, 9,
and 10). At the same time, the 2002 FDA
survey found that roughly as many
physicians thought DTC had a positive
effect on their practice as those who
thought there had been a negative
influence. Moreover, the 2002 FDA
survey found that roughly a third of
physicians surveyed thought that DTC
had essentially no influence on their
practice. The question of whether a
similar pattern will emerge now, despite
the growth of DTC, is a vital one.
In addition, with the proliferation of
social media platforms, the emergence
of online pharmaceutical marketing, and
the evolution of office detailing
practices (Refs. 11 and 12), FDA will
benefit by knowing more about
healthcare professionals’ awareness of
new and emerging drug promotion sites
and practices. The proposed survey will
address these issues.
Design Overview
We propose a nationally
representative sample of healthcare
professionals that will yield 2,000
responses from 500 general
practitioners, 500 specialists, 500 nurse
practitioners, and 500 physician
assistants. Such a design will help to
ensure our ability to discuss not only
healthcare professional perceptions
generally but also to assess potential
E:\FR\FM\11OCN1.SGM
11OCN1
pmangrum on DSK3VPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 197 / Thursday, October 11, 2012 / Notices
variation between different types of
healthcare professionals. The data will
be weighted to the national population
of physicians, nurse practitioners, and
physician assistants who have
prescribing authority. We will develop
weights to adjust for known unequal
selection probabilities, for unequal
response rates, and for any remaining
deviations between the sample and
population distributions. In the final
step, we will use poststratification to
calibrate the sample distribution to
known population distribution to
reduce the bias due to frame
undercoverage. We believe that
poststratification should reduce
undercoverage bias to some extent for
the same reasons that weighting
adjustment reduces nonresponse bias.
Population counts for use in
poststratification will be obtained from
the American Medical Association
Master List and Medical Marketing
Service lists for nurse practitioners and
physician assistants. Available variables
on which to weight include: State of
practice and specialty for nurse
practitioners and physician assistants.
For physicians, these variables include:
Age, gender, specialty, office based/
hospital based; degree (MD or DO) and
year of medical school graduation.
All parts of this study will be
administered over the Internet.
Participants will answer questions about
their attitudes about DTC and
professional prescription drug
promotion, their perceptions of the Bad
Ad program, and their usage of new
technologies, including social media
(for complete questionnaire contact
Daniel Gittleson (see FOR FURTHER
INFORMATION CONTACT). Demographic
information will also be collected. The
entire procedure is expected to last
approximately 20 minutes. This will be
a one-time (rather than annual)
information collection.
In the Federal Register of January 17,
2012 (77 FR 2299), FDA published a 60day notice requesting public comment
on the proposed collection of
information. FDA received five public
comment submissions which included
over 50 comments embedded. In the
following section, we outline the
observations and suggestions raised in
the comments and provide our
responses:
(Comment 1) Two comments
recommended surveying pharmacists in
addition to the health care professionals
described in the notice (i.e., general
practitioners, specialists, nurse
practitioners, and physician assistants).
(Response) We respectfully
acknowledge the large role played by
pharmacists in the health care system.
VerDate Mar<15>2010
14:03 Oct 10, 2012
Jkt 229001
However, the purpose of our survey is
to query health care professionals with
prescribing privileges. One comment
noted that pharmacists have some
limited prescribing privileges in certain
States. This is true; pharmacists have
certain privileges in Florida, can
prescribe controlled substances under
Collaborative Drug Therapy
Management agreements in seven
States, and with specific advanced
training can prescribe within the
Veterans Administration system. This
contrasts with the nearly universal
prescribing privileges of nurse
practitioners and physician assistants,
with varying levels of physician
supervision. To maximize our resources,
we propose to maintain our current
distribution of health care professionals.
Given the variety of prescribing
privilege rights among physician
extenders in different states, however,
we will add a screening question to
ensure that our respondents do have
prescribing privileges.
(Comment 2) One comment
mentioned adding a variety of different
types of prescribers to our sample,
including dentists, doctors of
osteopathy, and podiatrists.
(Response) The comment incorrectly
notes that the 2002 survey did not
include a variety of prescribers.
Contrary to the comment, the 2002
survey did include a range of
specialties, reflecting those therapeutic
areas with the highest amount of DTC
advertising at that time. The current
survey will include specialists who
practice in therapeutic areas for which
DTC advertising is or has recently been
active: Dermatologists; endocrinologists;
allergists/pulmonologists, psychiatrists
(all of whom were sampled in 2002);
rheumatologists; cardiologists; ear, nose,
and throat doctors; urologists;
neurologists; and pain specialists.
(Comment 3) One comment
recommended that demographic
questions be added to the beginning of
the survey to attain adequate
representation, instead of occurring at
the end.
(Response) The Internet panel from
which this data will be collected already
contains much of the demographic
information we need to ensure that
participants represent a balanced
stratification of demographic variables.
When relevant information is not
available from the panel, screening
questions will be asked prior to the
questionnaire to obtain the desired
information. We prefer to keep other
demographic variables at the end of the
survey to avoid distracting participants
with questions about personal
information before they have answered
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
61763
substantive survey questions. We also
prefer to ask our most important
questions first to avoid any respondent
fatigue that may occur throughout the
survey. We expect that respondents will
have an easier time answering questions
about themselves; therefore, these
questions will be less subject to
participant fatigue.
(Comment 4) One comment
recommended adding open-ended
questions in several locations in the
survey.
(Response) We appreciate this
suggestion and agree that open-ended
questions could provide extra,
unprompted information from
respondents. However, given the current
length of the survey, it is likely that
adding many open-ended questions
would increase respondent demand
and, therefore, result in more
respondents quitting before completion.
Moreover, the addition of several openended questions would increase coding
burden without adding a commensurate
value to our data. Thus, we do not plan
to incorporate additional open-ended
questions. If we find data that we would
like to pursue further, we can
incorporate this approach into future
studies.
(Comment 5) One comment
recommended that we provide ‘‘don’t
know’’ and ‘‘it depends’’ responses for
many questions.
(Response) We understand the value
of providing such responses for items of
a factual nature and for items to which
health care professionals might not
know the answer (our items fall into the
second category). The drawback to
providing such response options,
however, is that we may lose
information by allowing respondents to
choose an easy response instead of
giving the item some thought. Research
by Krosnick et al. (Ref. 13) demonstrated
that providing ‘‘no opinion’’ options
likely results in the loss of data without
any corresponding increase in the data
quality. Thus, we prefer not to add these
options to the survey. We plan to
cognitively test the questionnaire before
fielding the survey, so we will observe
whether participants have particular
difficulty with any of the questions.
(Comment 6) A comment
recommended interpreting the results of
this survey cautiously and in tandem
with other ongoing research areas.
(Response) We agree that careful
interpretation of the data is crucial. We
plan to apply the most rigorous
standards of analysis and to interpret
the findings based on those analyses
alone. When relevant, we will assimilate
the findings from this project with other
research projects we conduct.
E:\FR\FM\11OCN1.SGM
11OCN1
pmangrum on DSK3VPTVN1PROD with NOTICES
61764
Federal Register / Vol. 77, No. 197 / Thursday, October 11, 2012 / Notices
(Comment 7) One comment suggested
that Q2 (now Q1) be asked as a
screening question.
(Response) We intend to screen based
on percentage of time prescribers spend
with patients. We do not believe
additional screening based on the
number of patients seen per week is
necessary. We will ask only one of the
three options provided in the draft
questionnaire. Other comments have
recommended asking respondents to
recall the last week in time, so we will
use that question to assess their patient
volume.
(Comment 8) One comment
recommended asking about ‘‘health and
lifestyle changes’’ as an additional
question in Q3 (now Q2).
(Response) We have added this item
to the questionnaire.
(Comment 9) This comment
recommended eliminating the ‘‘almost
always’’ option from Q3 (now Q2)
because it may confuse respondents in
terms of exactly what we are asking.
(Response) We have removed this
option and have changed the other
responses so now the only responses are
‘‘never,’’ ‘‘rarely,’’ ‘‘sometimes,’’ and
‘‘often.’’ We believe this better
represents the range of options available
to answer this question and will make
the question easier to answer.
(Comment 10) One comment
recommended that we add a response
option to Q4 for in-office programming
that occurs in waiting rooms.
(Response) We have deleted this
question entirely because of survey time
constraints.
(Comment 11) Two comments stated
that 1 week is a reasonable amount of
time to ask prescribers to recall
information in Q5 (now Q3).
(Response) As we have done in the
screener and as suggested by these
comments, we will use 1 week as the
time period.
(Comment 12) This comment
recommended that we use a more
specific probe in Q6 (now Q4) to gather
information on why prescribers feel
positively or negatively about patients
mentioning advertised prescription
drugs.
(Response) We have added a followup
probe (Q4a) to address why respondents
chose their answer.
(Comment 13) This comment
recommended asking prescribers how
their patients reference advertisements,
for example, whether they specifically
mention the drug’s name, the condition
the drug treats, or some element in the
ad such as a butterfly or bee (Q8; now
Q5).
(Response) While this is a very
interesting question, it is more relevant
VerDate Mar<15>2010
14:03 Oct 10, 2012
Jkt 229001
to marketers of these products and
outside the scope of what FDA hopes to
accomplish with this survey. Given the
number of questions in the survey, we
respectfully decline to add this
question.
(Comment 14) This comment
recommended shortening the timeframe
in Q9 (now Q6) from 1 month to 1 week.
(Response) Given the feedback from
this and other comments, we agree that
1 week is a reasonable amount of time
to reference when answering these
questions, and we have adjusted the
questionnaire to reflect this change.
(Comment 15) One comment
recommended wording changes to Q7.
(Response) Q7 has been deleted
because of survey time constraints.
(Comment 16) This comment asked
that the nature of the request also be
added to Q10 (now Q7).
(Response) Although we agree that
asking about the nature of the request
would be interesting, additional
questions would increase the burden on
respondents, and we think that other
areas of inquiry are more relevant at this
time. Please note that we have altered
the response option in this one
question, which will yield additional
information.
(Comment 17) One comment
recommended specifying in Q10 (now
Q7) that patients have requested a drug
after seeing it advertised.
(Response) The purpose of the
question is to assess the prescribing
behavior of the prescriber, not the
source of the patient’s request, so we
prefer to keep the question as is.
(Comment 18) This comment
recommended a change in the response
options in Q10 (now Q7) to further
delineate the prescriber’s behavior.
(Response) We agree that this is a
useful change and have implemented
this response format. We have made
further changes based on peer review
comments.
(Comment 19) Two comments
indicated that it may be difficult for
health care professionals to answer Q12
(now Q9) as written.
(Response) We agree that it might be
difficult for prescribers to reliably assess
the feelings and emotions of members of
another group. We have changed the
emphasis in this question from the
patient’s expectation to the health care
professional’s feeling of obligation, thus
eliminating the issue over response
options in the original item. We have
altered the question to put the focus
back on what prescribers feel rather
than what their patients feel. Please note
that we have also altered the response
options for this question to make the
question easier to answer.
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
(Comment 20) This comment
recommended emphasizing the part of
the stem of Q13 and Q14 (now Q11) that
states, ‘‘As a result of discussion about
advertised prescription drugs.’’
(Response) Given the survey length,
we have deleted original Q13, but this
comment applies to current Q11. We
have attempted to emphasize the
appropriate part of the stem in this
question and will be cognizant of this
issue when working with the
programmers of the actual survey. We
will use bolding techniques and color as
necessary to make sure that this part of
the question is highlighted.
(Comment 21) One comment
questioned the utility of asking
prescribers about a variety of behaviors
they engage in as a result of a
conversation about advertised drugs
(Q14; now Q11). Their argument is that
the prescriber may respond ‘‘never’’
because the subject did not come up,
not because they did not want to
provide that action.
(Response) We agree that this is a
possible interpretation of that response
and will be careful to include that in
interpretations of the data. Nevertheless,
we are interested in obtaining
information on the number of times
these behaviors occur and believe this is
a useful measure.
(Comment 22) One comment
recommended changing Q14 (now Q11)
from ‘‘provided a brochure for the drug’’
to ‘‘provided a patient education
brochure for the drug.’’
(Response) We respectfully decline to
add this phrase because not all
brochures may be considered patient
education brochures, and the addition
does not improve or clarify the question.
(Comment 23) One comment
recommended making Q15 (now Q12)
more specific.
(Response) The purpose of this
question is to get a general reaction to
DTC advertising. Although we cannot
statistically compare the results of this
survey to FDA’s 2002 physician survey
for a number of reasons, we plan to
descriptively compare results from the
new survey with data obtained in 2002;
thus, we prefer to keep the question as
is. Although we did not make the
question more specific, we have altered
the wording slightly to make it clearer.
(Comment 24) This comment
recommended the addition of several
questions about what happens in the
prescriber-patient relationship when
patients are exposed to advertised
prescription drugs (Q16; now Q13).
(Response) We agree that these are
useful questions and have revised the
questionnaire accordingly.
E:\FR\FM\11OCN1.SGM
11OCN1
pmangrum on DSK3VPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 197 / Thursday, October 11, 2012 / Notices
(Comment 25) One comment
suggested adding a question to Q16
(now Q13) about whether DTC
advertising increases the likelihood of
conversations that the prescriber would
not have otherwise had with his or her
patients.
(Response) We have included this
suggestion in the revised questionnaire.
(Comment 26) This comment
recommended that we add ‘‘the patient
requests to be taken off the prescribed
medicine’’ to Q17 (now Q10).
(Response) We agree this is a useful
addition and have added it to the
revised questionnaire.
(Comment 27) The comment agreed
that the item in Q17 (now Q10) asking
about patient recall of aspects of
advertised drugs they discuss with their
prescribers is valuable, but questions
whether the item as worded will yield
interpretable results.
(Response) We have revised the
question and response options and will
pay close attention to this when we
conduct cognitive testing with nine
participants prior to pretesting the
instrument.
(Comment 28) The comment
recommended removal of the series of
questions in Q17 (now Q10) because
many factors may enter into the
responses to each question. Specifically,
the comment refers to personal
characteristics of a patient that may
influence these answers.
(Response) We agree that patient
characteristics may play a role, but we
are interested in the overall responses of
prescribers to these questions. Other
surveys capture patient characteristics
that may influence this question (Ref.
14). We have made minor improvements
in the wording of these items based on
peer review comments.
(Comment 29) Two comments
recommended adding questions to Q18,
one of which referred to the effect of
DTC advertising on prescription drugs
patients are already taking.
(Response) We have added questions
on these topics to Q18 (now Q14).
(Comment 30) The comment
recommended the addition of several
items related to cost to Q21 (now Q17).
(Response) These questions are
outside the scope of the current project
because FDA does not have authority
over the cost of prescription drugs.
Given the current length of the survey,
we have chosen not to include these
recommendations.
(Comment 31) One comment
recommended the addition of two
questions to the question series for Q22.
(Response) We have included the
recommendation in Q14 of the revised
questionnaire.
VerDate Mar<15>2010
14:03 Oct 10, 2012
Jkt 229001
(Comment 32) This comment
encouraged FDA to cautiously interpret
the results of Q22 (now Q14), which
asks whether prescribers believe that
DTC advertising caused their patients to
think drugs work better than they
actually do.
(Response) We agree that all
responses should be interpreted
cautiously and will take care to avoid
overinterpreting beyond the data.
(Comment 33) The comment
suggested removing the concept of ‘‘less
expensive treatments’’ from Q22 (now
Q15) about whether prescribers thought
DTC advertising caused patients to want
advertised drugs over others.
(Response) Although we have heard
this complaint frequently in focus
groups, we have modified this question
so that instead of the comparator in the
question being ‘‘less expensive
treatments,’’ the comparator is ‘‘other
recommended treatments.’’
(Comment 34) This comment
recommended deleting the question
about the cost of prescription drugs
(Q22).
(Response) We have deleted this
question from the questionnaire.
(Comment 35) One comment
suggested a change in wording to Q23
(now Q16).
(Response) We have replaced the
word ‘‘diagnoses’’ with the word
‘‘treatment,’’ as suggested by the
comment.
(Comment 36) This comment refers to
Q23 (now Q18) and the questions
following it that inquire about patients
bringing coupons to their doctors for
specific prescription drugs. Coupons
and other incentives are frequently used
in DTC promotion. This comment
recommended rewording the question to
assess whether patients are more likely
to ask prescribers for drugs with
coupons rather than those without.
(Response) We are unsure how
prescribers would know this
information because they are likely not
current with the range of active
advertising campaigns at any given
time. We maintain that the currently
worded question is a useful measure for
assessing prescribers’ general opinions
about the use of incentives in DTC
promotion.
(Comment 37) The comment
expressed concern about Q23–25 (now
Q18–20) because they believe that
without clarification we may miss
important nuances such as the
possibility that a coupon may initiate a
quality conversation about an illness.
(Response) As with all questions in
this survey, we will carefully interpret
the data, making sure not to draw
conclusions not supported by the data.
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
61765
Nevertheless, we believe that if the
presentation of a coupon resulted in a
good doctor-patient conversation, the
respondent would indeed select a
positive answer to this question.
(Comment 38) Two comments stated
that Q25 (now Q20) repeats Q24 (now
Q19) in the questionnaire.
(Response) Q24 (now Q19), asked
only of respondents who have
encountered a patient with a coupon,
asks how they did feel about that. Q25
(now Q20), asked only of respondents
who have not encountered a patient
with a coupon, asks how they would
feel about that. Respondents will only
see one of these two questions,
depending on whether a patient has
ever asked them about a prescription
drug that has been advertised with a
coupon. We like the suggested wording
in one comment for Q24 (Q19) and have
applied it to both questions.
(Comment 39) The comment
suggested modifying Q26 to ask whether
prescribers have ever had patients
become concerned about their
medication after seeing an ad for it.
(Response) We believe this would
have been a good introductory question
for the former Q26; however, because of
survey time constraints, we were forced
to limit the number of questions in this
area. Based on peer review comments,
we replaced these questions with a
question that more directly asks
whether prescribers have ever had a
patient refuse to take or to stop taking
their medication for these reasons (now
Q21).
(Comment 40) One comment
recommended adding a response of
‘‘depends on the condition’’ to the
question of whether there should be
more or less information about medical
conditions in DTC advertising (Q27).
(Response) Because of survey time
constraints, this question has been
deleted.
(Comment 41) One comment
recommended changing the order of
Q28 and Q29.
(Response) Because of survey time
constraints, all questions in this series
have been deleted except Q29b (now
Q22).
(Comment 42) This comment has
taken a subsection of the questions
about awareness of the Bad Ad program
(Q31–37; now Q23–30) and claimed that
FDA is using this forum as a way to
inform prescribers about the Bad Ad
program.
(Response) Looking at the entire set of
questions, it is clear that the goal of this
series is to assess whether prescribers
have heard about the program and to
explore their opinions about it. A
description of the Bad Ad program is
E:\FR\FM\11OCN1.SGM
11OCN1
pmangrum on DSK3VPTVN1PROD with NOTICES
61766
Federal Register / Vol. 77, No. 197 / Thursday, October 11, 2012 / Notices
provided in current Q24 because we
want to ask the subsequent questions of
all respondents and can only do so if
they know about the program. This
survey provides a logical vehicle for
assessing opinions about the Bad Ad
program. Furthermore, because the Bad
Ad program is directly related to
prescription drug promotion, we believe
it is clearly within the scope of the
survey. We recognize, however, that we
did not make this clear in the
introductory section of the Federal
Register notice, and we have included
additional verbiage to remedy this
omission. We note that no other
comments expressed concern about
these questions.
(Comment 43) One comment
recommended wording changes to the
followup open-ended item about the
Bad Ad program (Q34a; now Q27).
(Response) We agree that the revised
wording is preferable and have
incorporated it into the questionnaire.
(Comment 44) One comment
recommended wording changes to Q36/
Q37 (now Q29/Q30).
(Response) We agree that changing the
wording of these two questions may
make them easier for respondents to
understand and have done so in the
questionnaire.
(Comment 45) This comment
recommended deleting Q38–43 (now
Q31–36) regarding social media
membership and participation, citing
the justification that the survey is about
DTC advertising and these questions are
irrelevant.
(Response) We reiterate that the
purpose of the survey is to obtain
opinions and responses from a variety of
prescribers regarding prescription drug
promotion. This topic encompasses both
professional and DTC advertising and
labeling and a variety of different media
through which this promotion occurs.
The Agency has an interest in
determining the extent of promotion in
emerging technologies such as social
media, and various stakeholders have
pressed the Agency to produce guidance
related to new technologies. This survey
provides an opportunity to explore
prescribers’ use of social media sites in
order to assess whether future research
is warranted regarding these emerging
and potentially promotional venues. We
have added language to the introduction
section to clarify the scope of the
survey.
(Comment 46) One comment
recommended that we change the word
‘‘post’’ to ‘‘comment’’ in Q42/Q43 (now
Q35/36).
(Response) We have made this change
in these two questions. Please note that
we have also added a time period to
VerDate Mar<15>2010
14:03 Oct 10, 2012
Jkt 229001
help respondents answer the questions
more easily.
(Comment 47) One comment
recommended the addition of Internet
search engines to Q44 (now Q37a and
37b).
(Response) We have added search
engines as an option for this question.
We have also separated the question
into two parts based on peer review
comments to avoid a cognitively
demanding ranking task.
(Comment 48) This comment
expressed support for FDA’s data
collection from health care professionals
regarding prescription drug promotion.
One general issue raised by this
comment was the exclusion and
inclusion criteria for prescribers.
(Response) Prescribers must see
patients at least 50 percent of the time
in a non-hospital or non-inpatient
setting. Primary care physicians will
include internists, general practitioners,
family practitioners, and obstetricians/
gynecologists (all of whom were
sampled in 2002). We will exclude
pediatricians because relatively little
DTC advertising is aimed at children or
their parents. Specialists will include
those who practice in therapeutic areas
for which DTC advertising is or has
recently been active: Dermatologists;
endocrinologists; allergists/
pulmonologists; psychiatrists (all of
whom were sampled in 2002);
rheumatologists; cardiologists; ear, nose,
and throat doctors; urologists;
neurologists; and pain specialists. Nurse
practitioners and physician assistants
must have prescribing privileges.
(Comment 49) One comment raised
the issue of weighting.
(Response) Although we did not
provide details on weighting in the 60day Federal Register notice, we agree
and have implemented all suggestions
provided by this comment. For example,
this comment noted that FDA did not
explain at what level results will be
reported (i.e., aggregate versus each
group as a separate sample). Results will
be reported both in aggregate and for
each group separately, and weights will
be adjusted to produce national-level
estimates.
(Comment 50) This comment
supported FDA’s use of equal-sized
samples of four different types of health
care professionals (general practitioners,
specialists, nurse practitioners, and
physician assistants) although it
suggests that the artificial nature of
equal-sized samples may make it
difficult to find population parameters
and targets to use for weighting
purposes.
(Response) We note that the target
population is all health care
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
professionals with prescribing authority
in the United States. This is considered
the inferential population, which is
rarely achieved. The proposed sample
will be selected from the ‘‘responding
population.’’ The final survey weights
will be constructed to reduce the
coverage error and to compensate for
nonresponse error and unequal
probability of selection to represent the
target population.
(Comment 51) This comment
expressed skepticism that sample
weighting can adjust or correct for
noncoverage that results from
inadequacies in sampling frames.
(Response) We agree that frame
undercoverage cannot completely
eliminate noncoverage bias in an
estimator completely but will apply
poststratification as the primary method
for dealing with this undercoverage
(Ref. 15). We believe that
poststratification should reduce this
bias to some extent for the same reasons
that weighting adjustment reduces
nonresponse bias. We will consider
trimming extreme weights and
redistributing them to avoid losses in
precision.
(Comment 52) With regard to the
questionnaire, this comment
recommended adding specific questions
about the prescriber’s practice,
including the size of the practice,
whether it is part of a managed care
organization, whether it is part of an
integrated health system that involves
hospitals, and whether the practice has
a low- or no-access policy with regard
to pharmaceutical sales representatives.
(Response) We agree that these may
be relevant variables, and these
questions are represented in the
demographic section.
(Comment 53) One comment
suggested adding a series of questions to
assess the market dynamics that may
affect prescribing decisions.
(Response) Although these are
interesting questions, they are outside
the scope of the current project. Many
of the suggested questions deal with
issues of cost and reimbursement,
which FDA does not regulate.
(Comment 54) One comment
recommended that we should ask
particular questions of nurse
practitioners and physician assistants to
assess their characteristics.
(Response) We agree with the
comment and have several questions in
the questionnaire, asked of all
respondents, that will address some of
these questions. We have added a
question to the screener to ensure that
all respondents have at least some
prescribing authority, and we have
added a question to the questionnaire to
E:\FR\FM\11OCN1.SGM
11OCN1
61767
Federal Register / Vol. 77, No. 197 / Thursday, October 11, 2012 / Notices
delve further into how much authority
respondents have. We will also ask all
respondents how many prescriptions
they write in 1 week.
(Comment 55) One comment
suggested reexamining the
questionnaire from the Office of
Prescription Drug Promotion’s online
DTC promotion study (Docket No. FDA–
2011–N–0230) in light of this survey to
explore the possibility of comparing
responses on similar questions.
(Response) We appreciate this
suggestion and will examine the data
from both studies to see if any
descriptive comparisons can be made.
Please note that in response to all
comments received, whether we have
adapted the suggestions or not, we will
specifically examine the items
mentioned in cognitive testing. During
this testing, nine respondents will
participate in the survey while
explaining why and how they have
chosen their answers and which
questions they find difficult to respond
to or to understand.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Screener ...............................................................................
Pretest ..................................................................................
Main Study ...........................................................................
3,500
25
2,000
1
1
1
3,500
25
2,000
0.03
0.33
0.33
105
8
660
Total ..............................................................................
........................
........................
........................
........................
773
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
pmangrum on DSK3VPTVN1PROD with NOTICES
V. References
The following references have been
placed on display in the Division of
Dockets Management (FDA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday. FDA has verified the
Web site addresses, but FDA is not
responsible for any subsequent changes
to the Web sites after this document
publishes in the Federal Register.
1. Fintor, L., ‘‘Direct-to-Consumer Marketing:
How Has it Fared?’’ Journal of the
National Cancer Institute, 94, 329–331,
2002.
2. Palumbo, F.B., and C.D. Mullins, ‘‘The
Development of Direct-to-Consumer
Prescription Drug Advertising
Regulations.’’ Food and Drug Law
Journal, 57, 423–443, 2002.
3. Curry, T.J., J. Jarosch, and S. Pacholok,
‘‘Are Direct to Consumer Advertisements
of Prescription Drugs Educational?
Comparing 1992 to 2002.’’ Journal of
Drug Education, 35, 2172–2232, 2005.
4. Government Accountability Office (GAO).
‘‘Improvements Needed in FDA’s
Oversight of Direct-to-Consumer
Advertising.’’ GAO–07–54. Washington,
DC: GAO, November 16, 2006.
5. Aikin, K.J., J.L. Swasy, and A.C. Braman,
‘‘Patient and Physician Attitudes and
Behaviors Associated With DTC
Promotion of Prescription Drugs,’’
Washington, DC: Food and Drug
Administration, November 19, 2004.
6. Naylor, M.D., and E.T. Kurtman, ‘‘The Role
of Nurse Practitioners in Reinventing
Primary Care.’’ Health Affairs, 29, 893–
899, 2010.
7. Murray, E., B. Lo, L. Pollack, K. Donelan,
and K. Lee, ‘‘Direct-to-Consumer
Advertising: Physicians’ Views of its
Effects on Quality of Care and the
Doctor-Patient Relationship.’’ Journal of
the American Board of Family Practice,
VerDate Mar<15>2010
14:03 Oct 10, 2012
Jkt 229001
16, 513–524, 2003.
8. Dey, E.L., ‘‘Working With Low Survey
Response Rates: The Efficacy of
Weighting Adjustments.’’ Research in
Higher Education, 38, 215–227, 1997.
9. Mintzes, B., M.L. Barer, R.L. Kravitz, A.
Kazanjian, K. Bassett, J. Lexchin, R.G.
Evans, R. Pan, and S.A. Marion,
‘‘Influence of Direct to Consumer
Pharmaceutical Advertising and Patients’
Requests on Prescribing Decisions: Two
Site Cross Sectional Study.’’ British
Medical Journal, 324, 278–279, 2002.
10. Mitra, A., J. Swasy, and K. Aikin, ‘‘How
Do Consumers Interpret Market
Leadership Claims in Direct-toConsumer Advertising of Prescription
Drugs?’’ Advances in Consumer
Research, 33, 381–387, 2006.
11. Donohue, J.M., M. Cevasco, and M.B.
Rosenthal, ‘‘A Decade of Direct-toConsumer Advertising of Prescription
Drugs.’’ New England Journal of
Medicine, 357, 673–681, 2007.
12. Chew, L.D., T.S. O’Young, T.K. Hazlet,
K.A. Bradley, C. Maynard, and D.S.
Lessler, ‘‘A Physician Survey of the
Effect of Drug Sample Availability on
Physician’s Behavior.’’ Journal of
General Internal Medicine, 15, 478–483,
2000.
13. Krosnick, J.A., A.L. Holbrook, M.K.
Berent, R.T. Carson, W.M. Hanemann,
R.J. Kopp, M. Conaway, ‘‘The Impact of
‘No Opinion’ Response Options on Data
Quality: Non-attitude Reduction or an
Invitation to Satisfice?’’ Public Opinion
Quarterly, 66, 371–403, 2002.
14. Prevention Magazine. (2011). https://
www.rodaleinc.com/newsroom/12thannual-survey-iconsumer-reaction-dtcadvertising-prescription-drugsi-reveals.
Last accessed March 29, 2012.
15. Korn, E.L., and B.I. Graubard, ‘‘Analysis
of Health Surveys’’ (p. 42, lines 10–16).
John Wiley & Sons: New York, NY, 1999.
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
Dated: October 4, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–24973 Filed 10–10–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–1025]
The Science of Small Clinical Trials;
Notice of Course
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug Administration
(FDA), together with the National
Institutes of Health (NIH) Office of Rare
Diseases Research, National Center for
Advancing Translational Sciences, is
announcing a course entitled ‘‘The
Science of Small Clinical Trials.’’ The
course is intended to present an overall
framework and provide training in the
scientific aspects of designing and
analyzing clinical trials based on small
study populations. The course will
bring together subject experts and
stakeholders to identify when such
trials should be conducted, along with
strategies and trial designs that are
conducive to overcoming the challenges
they present.
The goal of this course is to engage
and educate FDA reviewers, NIH
scientists, clinicians, academics and
industry representatives with
experience in human subject research,
seeking to build upon their existing
knowledge and to obtain a broader
E:\FR\FM\11OCN1.SGM
11OCN1
]]>Agencies
[Federal Register Volume 77, Number 197 (Thursday, October 11, 2012)]
[Notices]
[Pages 61761-61767]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-24973]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0018]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Healthcare
Professional Survey of Prescription Drug Promotion
AGENCY: Food and Drug Administration, HHS.
[[Page 61762]]
ACTION: Notice.
-----------------------------------------------------------------------
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
November 13, 2012.
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: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-New and
title, ``Healthcare Professional Survey of Prescription Drug
Promotion.'' Also include the FDA docket number found in brackets in
the heading of this document.
FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-5156,
Daniel.Gittleson@fda.hhs.gov.
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.
Healthcare Professional Survey of Prescription Drug Promotion (0910-
New)
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(d)(2)(c) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 393(d)(2)(c)) authorizes FDA to
conduct research relating to drugs and other FDA regulated products in
carrying out the provisions of the FD&C Act.
The pharmaceutical industry spends millions of dollars a year
promoting their products to American healthcare professionals and to
consumers. FDA regulates the promotion of prescription drugs to both
professionals and consumers. As such, FDA has an interest in
determining the attitudes, perceptions, and opinions of healthcare
professionals with prescribing authority regarding such promotion.
Direct to consumer (DTC) advertising captures the most public
attention, making it an important topic of interest to FDA, but the
bulk of industry resources are spent in professional promotion, making
this an equally important topic for investigation. The current research
is designed to explore prescriber opinions of professional and DTC
advertising and promotion as well as other aspects of prescriber
experience that relate to the promotion of prescription drugs.
The rise of DTC drug advertising and prescription drug promotion
has affected healthcare professionals in a number of ways. First,
healthcare professionals regularly encounter patients who have been
exposed to DTC ads. Second, healthcare professionals also see and hear
such ads directly as mass media consumers themselves. Since
clarification of the adequate provision requirement for prescription
drug broadcast ads in 1997, FDA has faced numerous questions about the
influence of DTC pharmaceutical marketing because such advertising
directly engages consumers and potentially affects interactions between
patients and their physicians (Refs. 1 and 2). Those questions have
grown more urgent with the growth of DTC in recent years (Refs. 3 and
4). In 2002, FDA considered this form of promotion sufficiently
important as a force in the physician-patient interaction that they
surveyed both patients and physicians regarding their perceptions of
DTC (Ref. 5). Now, nearly a decade later, there are critical reasons to
return to the field to gather more evidence on the influence of DTC in
the examination room and on the relationships between healthcare
professionals and patients.
One of the most noteworthy aspects of the current healthcare
environment in 2012 is the role now played by various physician
extenders. Naylor and Kurtzman (Ref. 6) recently noted that nurses are
the single largest group of healthcare professionals in the United
States and they argue that nurse practitioners will play an
increasingly vital role in primary care delivery. Similarly, physician
assistants also bolster the ability of our healthcare system to offer
some types of care at lower cost. The aforementioned 2002 FDA study did
not include nurse practitioners or physician assistants in the sample;
that study focused on general practitioners and specialists in several
key areas targeted by DTC. Murray and colleagues (Ref. 7) also
conducted a large-scale survey of U.S. physicians regarding their
perceptions of DTC, but they also did not include nurse practitioners
or physician assistants in their sample. Because DTC likely affects
daily interactions between patients and nurse practitioners and
physician assistants--similar to the 2002 FDA study that suggested the
influence of advertising on physicians' work lives--including these
groups in the new sample will further understanding of DTC in the
healthcare system.
Another limitation of the 2002 FDA study was the extent to which
the results were nationally representative. As FDA has acknowledged,
the initial set of results as reported were applicable to survey
respondents but were not weighted to reflect national statistics as to
the age, sex, and racial composition of the healthcare professional
population. Similar to many types of surveys that have struggled in
recent decades with declines in cooperation rates (Ref. 8), surveys of
healthcare professionals in general often can benefit from weighting to
reduce nonresponse bias. The current survey will include weighted
responses from respondents that will reflect national demographic
patterns.
Over the past decade, researchers have been able to better assess
how DTC has unfolded in the United States and determine the questions
that warrant further survey work. For example, researchers have worried
for a number of years that DTC might produce adverse outcomes, such as
clinically inappropriate patient requests for drugs or patient
overestimation of the efficacy of advertised medications (Refs. 5, 7,
9, and 10). At the same time, the 2002 FDA survey found that roughly as
many physicians thought DTC had a positive effect on their practice as
those who thought there had been a negative influence. Moreover, the
2002 FDA survey found that roughly a third of physicians surveyed
thought that DTC had essentially no influence on their practice. The
question of whether a similar pattern will emerge now, despite the
growth of DTC, is a vital one.
In addition, with the proliferation of social media platforms, the
emergence of online pharmaceutical marketing, and the evolution of
office detailing practices (Refs. 11 and 12), FDA will benefit by
knowing more about healthcare professionals' awareness of new and
emerging drug promotion sites and practices. The proposed survey will
address these issues.
Design Overview
We propose a nationally representative sample of healthcare
professionals that will yield 2,000 responses from 500 general
practitioners, 500 specialists, 500 nurse practitioners, and 500
physician assistants. Such a design will help to ensure our ability to
discuss not only healthcare professional perceptions generally but also
to assess potential
[[Page 61763]]
variation between different types of healthcare professionals. The data
will be weighted to the national population of physicians, nurse
practitioners, and physician assistants who have prescribing authority.
We will develop weights to adjust for known unequal selection
probabilities, for unequal response rates, and for any remaining
deviations between the sample and population distributions. In the
final step, we will use poststratification to calibrate the sample
distribution to known population distribution to reduce the bias due to
frame undercoverage. We believe that poststratification should reduce
undercoverage bias to some extent for the same reasons that weighting
adjustment reduces nonresponse bias. Population counts for use in
poststratification will be obtained from the American Medical
Association Master List and Medical Marketing Service lists for nurse
practitioners and physician assistants. Available variables on which to
weight include: State of practice and specialty for nurse practitioners
and physician assistants. For physicians, these variables include: Age,
gender, specialty, office based/hospital based; degree (MD or DO) and
year of medical school graduation.
All parts of this study will be administered over the Internet.
Participants will answer questions about their attitudes about DTC and
professional prescription drug promotion, their perceptions of the Bad
Ad program, and their usage of new technologies, including social media
(for complete questionnaire contact Daniel Gittleson (see FOR FURTHER
INFORMATION CONTACT). Demographic information will also be collected.
The entire procedure is expected to last approximately 20 minutes. This
will be a one-time (rather than annual) information collection.
In the Federal Register of January 17, 2012 (77 FR 2299), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received five public comment submissions
which included over 50 comments embedded. In the following section, we
outline the observations and suggestions raised in the comments and
provide our responses:
(Comment 1) Two comments recommended surveying pharmacists in
addition to the health care professionals described in the notice
(i.e., general practitioners, specialists, nurse practitioners, and
physician assistants).
(Response) We respectfully acknowledge the large role played by
pharmacists in the health care system. However, the purpose of our
survey is to query health care professionals with prescribing
privileges. One comment noted that pharmacists have some limited
prescribing privileges in certain States. This is true; pharmacists
have certain privileges in Florida, can prescribe controlled substances
under Collaborative Drug Therapy Management agreements in seven States,
and with specific advanced training can prescribe within the Veterans
Administration system. This contrasts with the nearly universal
prescribing privileges of nurse practitioners and physician assistants,
with varying levels of physician supervision. To maximize our
resources, we propose to maintain our current distribution of health
care professionals. Given the variety of prescribing privilege rights
among physician extenders in different states, however, we will add a
screening question to ensure that our respondents do have prescribing
privileges.
(Comment 2) One comment mentioned adding a variety of different
types of prescribers to our sample, including dentists, doctors of
osteopathy, and podiatrists.
(Response) The comment incorrectly notes that the 2002 survey did
not include a variety of prescribers. Contrary to the comment, the 2002
survey did include a range of specialties, reflecting those therapeutic
areas with the highest amount of DTC advertising at that time. The
current survey will include specialists who practice in therapeutic
areas for which DTC advertising is or has recently been active:
Dermatologists; endocrinologists; allergists/pulmonologists,
psychiatrists (all of whom were sampled in 2002); rheumatologists;
cardiologists; ear, nose, and throat doctors; urologists; neurologists;
and pain specialists.
(Comment 3) One comment recommended that demographic questions be
added to the beginning of the survey to attain adequate representation,
instead of occurring at the end.
(Response) The Internet panel from which this data will be
collected already contains much of the demographic information we need
to ensure that participants represent a balanced stratification of
demographic variables. When relevant information is not available from
the panel, screening questions will be asked prior to the questionnaire
to obtain the desired information. We prefer to keep other demographic
variables at the end of the survey to avoid distracting participants
with questions about personal information before they have answered
substantive survey questions. We also prefer to ask our most important
questions first to avoid any respondent fatigue that may occur
throughout the survey. We expect that respondents will have an easier
time answering questions about themselves; therefore, these questions
will be less subject to participant fatigue.
(Comment 4) One comment recommended adding open-ended questions in
several locations in the survey.
(Response) We appreciate this suggestion and agree that open-ended
questions could provide extra, unprompted information from respondents.
However, given the current length of the survey, it is likely that
adding many open-ended questions would increase respondent demand and,
therefore, result in more respondents quitting before completion.
Moreover, the addition of several open-ended questions would increase
coding burden without adding a commensurate value to our data. Thus, we
do not plan to incorporate additional open-ended questions. If we find
data that we would like to pursue further, we can incorporate this
approach into future studies.
(Comment 5) One comment recommended that we provide ``don't know''
and ``it depends'' responses for many questions.
(Response) We understand the value of providing such responses for
items of a factual nature and for items to which health care
professionals might not know the answer (our items fall into the second
category). The drawback to providing such response options, however, is
that we may lose information by allowing respondents to choose an easy
response instead of giving the item some thought. Research by Krosnick
et al. (Ref. 13) demonstrated that providing ``no opinion'' options
likely results in the loss of data without any corresponding increase
in the data quality. Thus, we prefer not to add these options to the
survey. We plan to cognitively test the questionnaire before fielding
the survey, so we will observe whether participants have particular
difficulty with any of the questions.
(Comment 6) A comment recommended interpreting the results of this
survey cautiously and in tandem with other ongoing research areas.
(Response) We agree that careful interpretation of the data is
crucial. We plan to apply the most rigorous standards of analysis and
to interpret the findings based on those analyses alone. When relevant,
we will assimilate the findings from this project with other research
projects we conduct.
[[Page 61764]]
(Comment 7) One comment suggested that Q2 (now Q1) be asked as a
screening question.
(Response) We intend to screen based on percentage of time
prescribers spend with patients. We do not believe additional screening
based on the number of patients seen per week is necessary. We will ask
only one of the three options provided in the draft questionnaire.
Other comments have recommended asking respondents to recall the last
week in time, so we will use that question to assess their patient
volume.
(Comment 8) One comment recommended asking about ``health and
lifestyle changes'' as an additional question in Q3 (now Q2).
(Response) We have added this item to the questionnaire.
(Comment 9) This comment recommended eliminating the ``almost
always'' option from Q3 (now Q2) because it may confuse respondents in
terms of exactly what we are asking.
(Response) We have removed this option and have changed the other
responses so now the only responses are ``never,'' ``rarely,''
``sometimes,'' and ``often.'' We believe this better represents the
range of options available to answer this question and will make the
question easier to answer.
(Comment 10) One comment recommended that we add a response option
to Q4 for in-office programming that occurs in waiting rooms.
(Response) We have deleted this question entirely because of survey
time constraints.
(Comment 11) Two comments stated that 1 week is a reasonable amount
of time to ask prescribers to recall information in Q5 (now Q3).
(Response) As we have done in the screener and as suggested by
these comments, we will use 1 week as the time period.
(Comment 12) This comment recommended that we use a more specific
probe in Q6 (now Q4) to gather information on why prescribers feel
positively or negatively about patients mentioning advertised
prescription drugs.
(Response) We have added a followup probe (Q4a) to address why
respondents chose their answer.
(Comment 13) This comment recommended asking prescribers how their
patients reference advertisements, for example, whether they
specifically mention the drug's name, the condition the drug treats, or
some element in the ad such as a butterfly or bee (Q8; now Q5).
(Response) While this is a very interesting question, it is more
relevant to marketers of these products and outside the scope of what
FDA hopes to accomplish with this survey. Given the number of questions
in the survey, we respectfully decline to add this question.
(Comment 14) This comment recommended shortening the timeframe in
Q9 (now Q6) from 1 month to 1 week.
(Response) Given the feedback from this and other comments, we
agree that 1 week is a reasonable amount of time to reference when
answering these questions, and we have adjusted the questionnaire to
reflect this change.
(Comment 15) One comment recommended wording changes to Q7.
(Response) Q7 has been deleted because of survey time constraints.
(Comment 16) This comment asked that the nature of the request also
be added to Q10 (now Q7).
(Response) Although we agree that asking about the nature of the
request would be interesting, additional questions would increase the
burden on respondents, and we think that other areas of inquiry are
more relevant at this time. Please note that we have altered the
response option in this one question, which will yield additional
information.
(Comment 17) One comment recommended specifying in Q10 (now Q7)
that patients have requested a drug after seeing it advertised.
(Response) The purpose of the question is to assess the prescribing
behavior of the prescriber, not the source of the patient's request, so
we prefer to keep the question as is.
(Comment 18) This comment recommended a change in the response
options in Q10 (now Q7) to further delineate the prescriber's behavior.
(Response) We agree that this is a useful change and have
implemented this response format. We have made further changes based on
peer review comments.
(Comment 19) Two comments indicated that it may be difficult for
health care professionals to answer Q12 (now Q9) as written.
(Response) We agree that it might be difficult for prescribers to
reliably assess the feelings and emotions of members of another group.
We have changed the emphasis in this question from the patient's
expectation to the health care professional's feeling of obligation,
thus eliminating the issue over response options in the original item.
We have altered the question to put the focus back on what prescribers
feel rather than what their patients feel. Please note that we have
also altered the response options for this question to make the
question easier to answer.
(Comment 20) This comment recommended emphasizing the part of the
stem of Q13 and Q14 (now Q11) that states, ``As a result of discussion
about advertised prescription drugs.''
(Response) Given the survey length, we have deleted original Q13,
but this comment applies to current Q11. We have attempted to emphasize
the appropriate part of the stem in this question and will be cognizant
of this issue when working with the programmers of the actual survey.
We will use bolding techniques and color as necessary to make sure that
this part of the question is highlighted.
(Comment 21) One comment questioned the utility of asking
prescribers about a variety of behaviors they engage in as a result of
a conversation about advertised drugs (Q14; now Q11). Their argument is
that the prescriber may respond ``never'' because the subject did not
come up, not because they did not want to provide that action.
(Response) We agree that this is a possible interpretation of that
response and will be careful to include that in interpretations of the
data. Nevertheless, we are interested in obtaining information on the
number of times these behaviors occur and believe this is a useful
measure.
(Comment 22) One comment recommended changing Q14 (now Q11) from
``provided a brochure for the drug'' to ``provided a patient education
brochure for the drug.''
(Response) We respectfully decline to add this phrase because not
all brochures may be considered patient education brochures, and the
addition does not improve or clarify the question.
(Comment 23) One comment recommended making Q15 (now Q12) more
specific.
(Response) The purpose of this question is to get a general
reaction to DTC advertising. Although we cannot statistically compare
the results of this survey to FDA's 2002 physician survey for a number
of reasons, we plan to descriptively compare results from the new
survey with data obtained in 2002; thus, we prefer to keep the question
as is. Although we did not make the question more specific, we have
altered the wording slightly to make it clearer.
(Comment 24) This comment recommended the addition of several
questions about what happens in the prescriber-patient relationship
when patients are exposed to advertised prescription drugs (Q16; now
Q13).
(Response) We agree that these are useful questions and have
revised the questionnaire accordingly.
[[Page 61765]]
(Comment 25) One comment suggested adding a question to Q16 (now
Q13) about whether DTC advertising increases the likelihood of
conversations that the prescriber would not have otherwise had with his
or her patients.
(Response) We have included this suggestion in the revised
questionnaire.
(Comment 26) This comment recommended that we add ``the patient
requests to be taken off the prescribed medicine'' to Q17 (now Q10).
(Response) We agree this is a useful addition and have added it to
the revised questionnaire.
(Comment 27) The comment agreed that the item in Q17 (now Q10)
asking about patient recall of aspects of advertised drugs they discuss
with their prescribers is valuable, but questions whether the item as
worded will yield interpretable results.
(Response) We have revised the question and response options and
will pay close attention to this when we conduct cognitive testing with
nine participants prior to pretesting the instrument.
(Comment 28) The comment recommended removal of the series of
questions in Q17 (now Q10) because many factors may enter into the
responses to each question. Specifically, the comment refers to
personal characteristics of a patient that may influence these answers.
(Response) We agree that patient characteristics may play a role,
but we are interested in the overall responses of prescribers to these
questions. Other surveys capture patient characteristics that may
influence this question (Ref. 14). We have made minor improvements in
the wording of these items based on peer review comments.
(Comment 29) Two comments recommended adding questions to Q18, one
of which referred to the effect of DTC advertising on prescription
drugs patients are already taking.
(Response) We have added questions on these topics to Q18 (now
Q14).
(Comment 30) The comment recommended the addition of several items
related to cost to Q21 (now Q17).
(Response) These questions are outside the scope of the current
project because FDA does not have authority over the cost of
prescription drugs. Given the current length of the survey, we have
chosen not to include these recommendations.
(Comment 31) One comment recommended the addition of two questions
to the question series for Q22.
(Response) We have included the recommendation in Q14 of the
revised questionnaire.
(Comment 32) This comment encouraged FDA to cautiously interpret
the results of Q22 (now Q14), which asks whether prescribers believe
that DTC advertising caused their patients to think drugs work better
than they actually do.
(Response) We agree that all responses should be interpreted
cautiously and will take care to avoid overinterpreting beyond the
data.
(Comment 33) The comment suggested removing the concept of ``less
expensive treatments'' from Q22 (now Q15) about whether prescribers
thought DTC advertising caused patients to want advertised drugs over
others.
(Response) Although we have heard this complaint frequently in
focus groups, we have modified this question so that instead of the
comparator in the question being ``less expensive treatments,'' the
comparator is ``other recommended treatments.''
(Comment 34) This comment recommended deleting the question about
the cost of prescription drugs (Q22).
(Response) We have deleted this question from the questionnaire.
(Comment 35) One comment suggested a change in wording to Q23 (now
Q16).
(Response) We have replaced the word ``diagnoses'' with the word
``treatment,'' as suggested by the comment.
(Comment 36) This comment refers to Q23 (now Q18) and the questions
following it that inquire about patients bringing coupons to their
doctors for specific prescription drugs. Coupons and other incentives
are frequently used in DTC promotion. This comment recommended
rewording the question to assess whether patients are more likely to
ask prescribers for drugs with coupons rather than those without.
(Response) We are unsure how prescribers would know this
information because they are likely not current with the range of
active advertising campaigns at any given time. We maintain that the
currently worded question is a useful measure for assessing
prescribers' general opinions about the use of incentives in DTC
promotion.
(Comment 37) The comment expressed concern about Q23-25 (now Q18-
20) because they believe that without clarification we may miss
important nuances such as the possibility that a coupon may initiate a
quality conversation about an illness.
(Response) As with all questions in this survey, we will carefully
interpret the data, making sure not to draw conclusions not supported
by the data. Nevertheless, we believe that if the presentation of a
coupon resulted in a good doctor-patient conversation, the respondent
would indeed select a positive answer to this question.
(Comment 38) Two comments stated that Q25 (now Q20) repeats Q24
(now Q19) in the questionnaire.
(Response) Q24 (now Q19), asked only of respondents who have
encountered a patient with a coupon, asks how they did feel about that.
Q25 (now Q20), asked only of respondents who have not encountered a
patient with a coupon, asks how they would feel about that. Respondents
will only see one of these two questions, depending on whether a
patient has ever asked them about a prescription drug that has been
advertised with a coupon. We like the suggested wording in one comment
for Q24 (Q19) and have applied it to both questions.
(Comment 39) The comment suggested modifying Q26 to ask whether
prescribers have ever had patients become concerned about their
medication after seeing an ad for it.
(Response) We believe this would have been a good introductory
question for the former Q26; however, because of survey time
constraints, we were forced to limit the number of questions in this
area. Based on peer review comments, we replaced these questions with a
question that more directly asks whether prescribers have ever had a
patient refuse to take or to stop taking their medication for these
reasons (now Q21).
(Comment 40) One comment recommended adding a response of ``depends
on the condition'' to the question of whether there should be more or
less information about medical conditions in DTC advertising (Q27).
(Response) Because of survey time constraints, this question has
been deleted.
(Comment 41) One comment recommended changing the order of Q28 and
Q29.
(Response) Because of survey time constraints, all questions in
this series have been deleted except Q29b (now Q22).
(Comment 42) This comment has taken a subsection of the questions
about awareness of the Bad Ad program (Q31-37; now Q23-30) and claimed
that FDA is using this forum as a way to inform prescribers about the
Bad Ad program.
(Response) Looking at the entire set of questions, it is clear that
the goal of this series is to assess whether prescribers have heard
about the program and to explore their opinions about it. A description
of the Bad Ad program is
[[Page 61766]]
provided in current Q24 because we want to ask the subsequent questions
of all respondents and can only do so if they know about the program.
This survey provides a logical vehicle for assessing opinions about the
Bad Ad program. Furthermore, because the Bad Ad program is directly
related to prescription drug promotion, we believe it is clearly within
the scope of the survey. We recognize, however, that we did not make
this clear in the introductory section of the Federal Register notice,
and we have included additional verbiage to remedy this omission. We
note that no other comments expressed concern about these questions.
(Comment 43) One comment recommended wording changes to the
followup open-ended item about the Bad Ad program (Q34a; now Q27).
(Response) We agree that the revised wording is preferable and have
incorporated it into the questionnaire.
(Comment 44) One comment recommended wording changes to Q36/Q37
(now Q29/Q30).
(Response) We agree that changing the wording of these two
questions may make them easier for respondents to understand and have
done so in the questionnaire.
(Comment 45) This comment recommended deleting Q38-43 (now Q31-36)
regarding social media membership and participation, citing the
justification that the survey is about DTC advertising and these
questions are irrelevant.
(Response) We reiterate that the purpose of the survey is to obtain
opinions and responses from a variety of prescribers regarding
prescription drug promotion. This topic encompasses both professional
and DTC advertising and labeling and a variety of different media
through which this promotion occurs. The Agency has an interest in
determining the extent of promotion in emerging technologies such as
social media, and various stakeholders have pressed the Agency to
produce guidance related to new technologies. This survey provides an
opportunity to explore prescribers' use of social media sites in order
to assess whether future research is warranted regarding these emerging
and potentially promotional venues. We have added language to the
introduction section to clarify the scope of the survey.
(Comment 46) One comment recommended that we change the word
``post'' to ``comment'' in Q42/Q43 (now Q35/36).
(Response) We have made this change in these two questions. Please
note that we have also added a time period to help respondents answer
the questions more easily.
(Comment 47) One comment recommended the addition of Internet
search engines to Q44 (now Q37a and 37b).
(Response) We have added search engines as an option for this
question. We have also separated the question into two parts based on
peer review comments to avoid a cognitively demanding ranking task.
(Comment 48) This comment expressed support for FDA's data
collection from health care professionals regarding prescription drug
promotion. One general issue raised by this comment was the exclusion
and inclusion criteria for prescribers.
(Response) Prescribers must see patients at least 50 percent of the
time in a non-hospital or non-inpatient setting. Primary care
physicians will include internists, general practitioners, family
practitioners, and obstetricians/gynecologists (all of whom were
sampled in 2002). We will exclude pediatricians because relatively
little DTC advertising is aimed at children or their parents.
Specialists will include those who practice in therapeutic areas for
which DTC advertising is or has recently been active: Dermatologists;
endocrinologists; allergists/pulmonologists; psychiatrists (all of whom
were sampled in 2002); rheumatologists; cardiologists; ear, nose, and
throat doctors; urologists; neurologists; and pain specialists. Nurse
practitioners and physician assistants must have prescribing
privileges.
(Comment 49) One comment raised the issue of weighting.
(Response) Although we did not provide details on weighting in the
60-day Federal Register notice, we agree and have implemented all
suggestions provided by this comment. For example, this comment noted
that FDA did not explain at what level results will be reported (i.e.,
aggregate versus each group as a separate sample). Results will be
reported both in aggregate and for each group separately, and weights
will be adjusted to produce national-level estimates.
(Comment 50) This comment supported FDA's use of equal-sized
samples of four different types of health care professionals (general
practitioners, specialists, nurse practitioners, and physician
assistants) although it suggests that the artificial nature of equal-
sized samples may make it difficult to find population parameters and
targets to use for weighting purposes.
(Response) We note that the target population is all health care
professionals with prescribing authority in the United States. This is
considered the inferential population, which is rarely achieved. The
proposed sample will be selected from the ``responding population.''
The final survey weights will be constructed to reduce the coverage
error and to compensate for nonresponse error and unequal probability
of selection to represent the target population.
(Comment 51) This comment expressed skepticism that sample
weighting can adjust or correct for noncoverage that results from
inadequacies in sampling frames.
(Response) We agree that frame undercoverage cannot completely
eliminate noncoverage bias in an estimator completely but will apply
poststratification as the primary method for dealing with this
undercoverage (Ref. 15). We believe that poststratification should
reduce this bias to some extent for the same reasons that weighting
adjustment reduces nonresponse bias. We will consider trimming extreme
weights and redistributing them to avoid losses in precision.
(Comment 52) With regard to the questionnaire, this comment
recommended adding specific questions about the prescriber's practice,
including the size of the practice, whether it is part of a managed
care organization, whether it is part of an integrated health system
that involves hospitals, and whether the practice has a low- or no-
access policy with regard to pharmaceutical sales representatives.
(Response) We agree that these may be relevant variables, and these
questions are represented in the demographic section.
(Comment 53) One comment suggested adding a series of questions to
assess the market dynamics that may affect prescribing decisions.
(Response) Although these are interesting questions, they are
outside the scope of the current project. Many of the suggested
questions deal with issues of cost and reimbursement, which FDA does
not regulate.
(Comment 54) One comment recommended that we should ask particular
questions of nurse practitioners and physician assistants to assess
their characteristics.
(Response) We agree with the comment and have several questions in
the questionnaire, asked of all respondents, that will address some of
these questions. We have added a question to the screener to ensure
that all respondents have at least some prescribing authority, and we
have added a question to the questionnaire to
[[Page 61767]]
delve further into how much authority respondents have. We will also
ask all respondents how many prescriptions they write in 1 week.
(Comment 55) One comment suggested reexamining the questionnaire
from the Office of Prescription Drug Promotion's online DTC promotion
study (Docket No. FDA-2011-N-0230) in light of this survey to explore
the possibility of comparing responses on similar questions.
(Response) We appreciate this suggestion and will examine the data
from both studies to see if any descriptive comparisons can be made.
Please note that in response to all comments received, whether we
have adapted the suggestions or not, we will specifically examine the
items mentioned in cognitive testing. During this testing, nine
respondents will participate in the survey while explaining why and how
they have chosen their answers and which questions they find difficult
to respond to or to understand.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
Activity Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
Screener........................ 3,500 1 3,500 0.03 105
Pretest......................... 25 1 25 0.33 8
Main Study...................... 2,000 1 2,000 0.33 660
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 773
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
V. References
The following references have been placed on display in the
Division of Dockets Management (FDA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852 and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
FDA has verified the Web site addresses, but FDA is not responsible for
any subsequent changes to the Web sites after this document publishes
in the Federal Register.
1. Fintor, L., ``Direct-to-Consumer Marketing: How Has it Fared?''
Journal of the National Cancer Institute, 94, 329-331, 2002.
2. Palumbo, F.B., and C.D. Mullins, ``The Development of Direct-to-
Consumer Prescription Drug Advertising Regulations.'' Food and Drug
Law Journal, 57, 423-443, 2002.
3. Curry, T.J., J. Jarosch, and S. Pacholok, ``Are Direct to
Consumer Advertisements of Prescription Drugs Educational? Comparing
1992 to 2002.'' Journal of Drug Education, 35, 2172-2232, 2005.
4. Government Accountability Office (GAO). ``Improvements Needed in
FDA's Oversight of Direct-to-Consumer Advertising.'' GAO-07-54.
Washington, DC: GAO, November 16, 2006.
5. Aikin, K.J., J.L. Swasy, and A.C. Braman, ``Patient and Physician
Attitudes and Behaviors Associated With DTC Promotion of
Prescription Drugs,'' Washington, DC: Food and Drug Administration,
November 19, 2004.
6. Naylor, M.D., and E.T. Kurtman, ``The Role of Nurse Practitioners
in Reinventing Primary Care.'' Health Affairs, 29, 893-899, 2010.
7. Murray, E., B. Lo, L. Pollack, K. Donelan, and K. Lee, ``Direct-
to-Consumer Advertising: Physicians' Views of its Effects on Quality
of Care and the Doctor-Patient Relationship.'' Journal of the
American Board of Family Practice, 16, 513-524, 2003.
8. Dey, E.L., ``Working With Low Survey Response Rates: The Efficacy
of Weighting Adjustments.'' Research in Higher Education, 38, 215-
227, 1997.
9. Mintzes, B., M.L. Barer, R.L. Kravitz, A. Kazanjian, K. Bassett,
J. Lexchin, R.G. Evans, R. Pan, and S.A. Marion, ``Influence of
Direct to Consumer Pharmaceutical Advertising and Patients' Requests
on Prescribing Decisions: Two Site Cross Sectional Study.'' British
Medical Journal, 324, 278-279, 2002.
10. Mitra, A., J. Swasy, and K. Aikin, ``How Do Consumers Interpret
Market Leadership Claims in Direct-to-Consumer Advertising of
Prescription Drugs?'' Advances in Consumer Research, 33, 381-387,
2006.
11. Donohue, J.M., M. Cevasco, and M.B. Rosenthal, ``A Decade of
Direct-to-Consumer Advertising of Prescription Drugs.'' New England
Journal of Medicine, 357, 673-681, 2007.
12. Chew, L.D., T.S. O'Young, T.K. Hazlet, K.A. Bradley, C. Maynard,
and D.S. Lessler, ``A Physician Survey of the Effect of Drug Sample
Availability on Physician's Behavior.'' Journal of General Internal
Medicine, 15, 478-483, 2000.
13. Krosnick, J.A., A.L. Holbrook, M.K. Berent, R.T. Carson, W.M.
Hanemann, R.J. Kopp, M. Conaway, ``The Impact of `No Opinion'
Response Options on Data Quality: Non-attitude Reduction or an
Invitation to Satisfice?'' Public Opinion Quarterly, 66, 371-403,
2002.
14. Prevention Magazine. (2011). https://www.rodaleinc.com/newsroom/12th-annual-survey-iconsumer-reaction-dtc-advertising-prescription-drugsi-reveals. Last accessed March 29, 2012.
15. Korn, E.L., and B.I. Graubard, ``Analysis of Health Surveys''
(p. 42, lines 10-16). John Wiley & Sons: New York, NY, 1999.
Dated: October 4, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-24973 Filed 10-10-12; 8:45 am]
BILLING CODE 4160-01-P
