[Federal Register Volume 77, Number 10 (Tuesday, January 17, 2012)]
[Notices]
[Pages 2299-2301]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-638]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0018]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Healthcare Professional Survey of Prescription Drug 
Promotion

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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[[Page 2300]]

SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on the Healthcare Professional Survey of 
Prescription Drug Promotion. This survey is designed to explore the 
opinions and perceptions of physicians, nurse practitioners, and 
physician assistants with regard to the promotion of prescription drugs 
to consumers and healthcare providers.

DATES: Submit either electronic or written comments on the collection 
of information by March 19, 2012.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Juanmanuel Vilela, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr. 
PI50-400B, Rockville, MD 20850, (301) 796-7651, 
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information before 
submitting the collection to OMB for approval. To comply with this 
requirement, FDA is publishing notice of the proposed collection of 
information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Healthcare Professional Survey of Prescription Drug Promotion--(OMB 
Control Number 0910--New)

I. Regulatory Background

    Section 1701(a)(4) of the Public Health Service Act (42 U.S.C. 
300u(a)(4)) authorizes the Food and Drug Administration (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.

II. Description

    The rise of direct-to-consumer (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 
advertising 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 advertising (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 advertising 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 2011 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 providers 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 advertising. Murray and colleagues (Ref. 7) also 
conducted a large-scale survey of U.S. physicians regarding their 
perceptions of DTC advertising, but they also did not include nurse 
practitioners or physician assistants in their sample. Because DTC 
advertising 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 advertising 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 advertising 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 advertising 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

[[Page 2301]]

survey found that roughly as many physicians thought DTC advertising 
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 advertising had 
essentially no influence on their practice. The question of whether a 
similar pattern will emerge now, despite the growth of DTC advertising, 
is a vital one. Furthermore, FDA will benefit from knowing more detail 
about the various types of perceived effects DTC advertising might 
have. For example, some healthcare professionals might be ambivalent 
rather than strongly in favor of or opposed to DTC advertising. 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.

III. Method 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 variation between different types of healthcare 
professionals. This sample will be recruited from a national Internet 
healthcare professional panel that includes over 70,000 individuals 
originating from the American Medical Association master file and other 
medical organizations. Because there are not enough individuals in this 
panel to satisfy the needs of the proposed project, nurse practitioners 
and physician assistants will be specially recruited from relevant 
professional organizations.
    Healthcare providers are a difficult group to recruit, and so 
several strategies will be put into place to achieve a high response 
rate. These include sending prenotification letters before online 
invitation, lengthening the data collection period to 8 weeks (from the 
more typical 4 weeks), tailoring contact materials, disclosing FDA 
sponsorship on survey materials, and conducting reminder telephone 
calls. Appropriate weighting will be applied to adjust for any survey 
nonresponse as well as any noncoverage or undersampling and 
oversampling resulting from the sample design.
    Participants who agree to participate will answer questions online. 
The survey is expected to take no longer than 20 minutes. This will be 
a one-time (versus annual) data collection.
    FDA estimates the burden of this collection of information as 
follows: The total respondent sample for this data collection is 2,025. 
We will sample 25 respondents for basic programming pretesting and 
2,000 respondents for the full study. We estimate the response burden 
to be 20 minutes, for a burden of 1,008 hours.

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of                    Average burden
            Activity                 Number of     responses per   Total annual    per response     Total hours
                                    respondents     respondent       responses      (in hours)
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Screener........................          10,000               1          10,000            2/60             333
Pretest.........................              25               1              25           20/60               8
Main Study......................           2,000               1           2,000           20/60             667
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    Total.......................  ..............  ..............  ..............  ..............           1,008
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There are no capital costs or operating and maintenance costs associated with this collection of information.

IV. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES) and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday.

    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, et al., ``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, et al., ``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, et al., ``A Physician 
Survey of the Effect of Drug Sample Availability on Physician's 
Behavior,'' Journal of General Internal Medicine, 15, 478-483, 2000.


    Dated: January 10, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-638 Filed 1-13-12; 8:45 am]
BILLING CODE 4160-01-P