
[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]


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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.

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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 
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.

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    (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.

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    (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

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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). http://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


