[Federal Register Volume 83, Number 51 (Thursday, March 15, 2018)]
[Notices]
[Pages 11539-11542]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-05235]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0215]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
announcing an opportunity for public comment on the proposed collection 
of certain information by the Agency. Under the Paperwork Reduction Act 
of 1995 (PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on ``Health Care Professional 
Survey of Professional Prescription Drug Promotion.'' This study will 
examine how health care professionals experience and perceive 
prescription drug promotion directed to them.

DATES: Submit either electronic or written comments on the collection 
of information by May 14, 2018.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before May 14, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of May 14, 2018. Comments received by 
mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2018-N-0215 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Health Care Professional Survey 
of Professional Prescription Drug Promotion.'' Received comments, those 
filed in a timely manner (see ADDRESSES), will be placed

[[Page 11540]]

in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through 
Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    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, including each 
proposed extension of an existing 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.

Health Care Professional Survey of Professional Prescription Drug 
Promotion

OMB Control Number 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 1003(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.
    As part of its federal mandate, FDA regulates whether direct-to-
consumer (DTC) advertising of prescription drug products is truthful, 
balanced, and accurately communicated (see 21 U.S.C. 352(n)). 
Similarly, the FD&C Act prohibits the dissemination of false or 
misleading information about medications in consumer-directed and 
professional prescription drug promotion. FDA regulates within the 
framework of free speech and due process principles of the United 
States Constitution. To inform current and future policies, and to seek 
to enhance audience comprehension, the Office of Prescription Drug 
Promotion conducts research focusing on (1) advertising features 
including content and format, (2) target populations, and (3) research 
quality. This proposed research focuses on the physician target 
population. FDA surveyed physicians about their attitudes toward DTC 
advertising and its role in their relationships with their patients in 
2002 (Ref. 1) and again in 2013 (Refs. 2 and 3). The 2013 survey 
included multiple types of prescribers: Primary care physicians, 
specialists, nurse practitioners, and physician assistants. Whereas the 
focus of both previous FDA surveys was on DTC advertising and 
promotion, the current study is designed to address issues related to 
professional prescription drug promotion. The goal is to query a 
representative sample of health care professionals (HCPs) about their 
opinions of promotional materials and procedures targeted at HCPs, 
clinical trial design and knowledge, and FDA approval status. We will 
also take this opportunity to ask HCPs briefly about their knowledge of 
abuse-deterrent formulations for opioid products.
    To educate themselves about prescription drugs, HCPs sometimes rely 
on professionally directed promotional information (Refs. 4-8). In 
2012, pharmaceutical companies spent more than $24 billion on marketing 
to physicians (Ref. 9). The industry exposes health care professionals 
to promotional materials through a variety of mechanisms, including 
communication with pharmaceutical representatives, journal ads, 
prescribing software, presentations at sponsored meetings, and direct 
mail ads (Ref. 10). Several studies indicate that data presented in 
promotional materials may not be fully comprehended and may even 
potentially be misleading due to a variety of causes, such as 
insufficient information, unsupported claims, or a failure to disclose 
limitations of the information presented (Refs. 11-15).
    Although HCPs are learned intermediaries, like most people, they 
may rely on heuristics in making decisions and may have cognitive 
biases in the type of information they attend to at any given time. 
They may be persuaded by strong statements and may not have the time to 
ascertain accuracy of such information (Ref. 16). The proposed survey 
will provide further insights about how professionally targeted 
prescription drug promotion might influence health care professionals' 
decision-making processes and practices and how

[[Page 11541]]

information may be communicated more effectively. It is important to 
note that FDA does not regulate the practice of medicine. However, as 
previously mentioned, FDA does regulate prescription drug promotion. 
This survey is designed to inform FDA of various responses to and 
impacts of prescription drug promotion of prescription drugs.
    The general research questions in the survey are as follows:
    1. What methods and/or channels are used to disseminate 
prescription drug promotional information to health care professionals/
prescribers?
    2. How knowledgeable and interested are HCPs in clinical trial data 
and its presence in prescription drug promotion?
    3. How familiar are HCPs with the FDA approval of prescription 
drugs and how does this translate into practice?
    In addition, given the critical nature of the opioid situation in 
the United States at this time, we plan to ask several questions about 
prescription drug promotion of opioid products.
    HCPs who fall into one of four categories will be recruited online 
through WebMD's Medscape subscriber network. We propose to complete 700 
primary care physician, 600 specialist, 350 nurse practitioner, and 350 
physician assistant surveys. HCPs will be included if they see patients 
at least 50 percent of the time. Both Doctors of Medicine and Doctors 
of Osteopathy will be included. Primary care physicians will include 
those who indicate they work in general, family, or internal medicine. 
Specialties were chosen based on prevalence in the United States and 
prescription drug promotional activity. Specialists will include 
cardiologists, dermatologists, endocrinologists, neurologists, 
obstetrician/gynecologists, oncologists, ophthalmologists, 
psychiatrists, rheumatologists, and urologists. The data will be 
weighted to adjust for differential coverage of select characteristics 
such as region and respondent age and gender. Pretesting with 25 
respondents will take place before the main study to evaluate the 
procedures and measures used in the main study.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
           Activity                Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
                                                  Pretest Study
----------------------------------------------------------------------------------------------------------------
HCP screener..................              63               1              63  0.08 (5 minutes)               5
Informed Consent..............              25               1              25  0.08 (5 minutes)               2
HCP Survey....................              25               1              25  0.33 (20                       8
                                                                                 minutes).
----------------------------------------------------------------------------------------------------------------
                                                   Main Study
----------------------------------------------------------------------------------------------------------------
HCP screener..................           5,037               1           5,037  0.08 (5 minutes)             403
Informed Consent..............           2,000               1           2,000  0.08 (5 minutes)             160
HCP Survey....................           2,000               1           2,000  0.33 (20                     660
                                                                                 minutes).
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................           1,238
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs and maintenance costs associated with this collection of information.

II. References

    The following references are on display in the Dockets Management 
Staff (see ADDRESSES) and are available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also 
available electronically at https://www.regulations.gov. FDA has 
verified the website addresses, as of the date this document publishes 
in the Federal Register, but websites are subject to change over time.

1. Available at: https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm090276.htm. Last accessed 
January 26, 2018.
2. Betts, K.R., A.C. O'Donoghue, K.J. Aikin, et al. (2016). 
``Healthcare Professional Social Media Membership and Participation: 
Findings From a Nationally Representative Sample,'' Journal of the 
American Association of Nurse Practitioners. Doi: 10.1002/2327-
6924.12383.
3. O'Donoghue, A.C., V. Boudewyns, K.J. Aikin, et al. (2015). 
``Awareness of FDA's Bad Ad Program and Education Regarding 
Pharmaceutical Advertising: A National Survey of Prescribers in 
Ambulatory Care Settings,'' Journal of Health Communication, vol. 
20(11), pp. 1330-1336.
4. Crigger, N.J. (2005). ``Pharmaceutical Promotions and Conflict of 
Interest in Nurse Practitioner's Decision Making: The Undiscovered 
Country,'' Journal of the American Academy of Nurse Practitioners, 
vol. 17(6), pp. 207-212.
5. Fischer, M.A., M.E. Keough, J.L. Baril, et al. (2009). 
``Prescribers and Pharmaceutical Representatives: Why Are We Still 
Meeting?'' Journal of General Internal Medicine, vol. 24(7), pp. 
795-801.
6. C. Robertson, S. Rose, and A.S. Kesselheim. (2012). ``Effect of 
Financial Relationships on the Behaviors of Health Care 
Professionals: A Review of the Evidence,'' The Journal of Law, 
Medicine & Ethics, vol. 40(3), pp. 452-466.
7. Srivastava, V., M. Handa, and A. Vohra. (2014). ``Promotional 
Tools: Do Physicians Really Bite the Hook?'' Drishtikon: A 
Management Journal, vol. 5(2).
8. Austad, K.E., J. Avorn, J.M. Franklin, et al. (2014). 
``Association of Marketing Interactions With Medical Trainees' 
Knowledge About Evidence-Based Prescribing: Results From a National 
Survey,'' JAMA Internal Medicine, vol. 174(8), pp. 1283-1290.
9. Cegedim Strategic Data. (2013). ``2012 U.S. Pharmaceutical 
Company Promotion Spending.'' Available at: http://www.skainfo.com/health_care_market_reports/2012_promotional_spending.pdf.
10. Spurling, G.K., P.R. Mansfield, B.D. Montgomery, et al. (2010). 
``Information From Pharmaceutical Companies and the Quality, 
Quantity, and Cost of Physicians' Prescribing: A Systematic 
Review,'' PLoS Medicine, vol. 7(10), e1000352. doi: 10.1371/
jounal.pmed. 1000352.
11. Villanueva, P., S. Peir[oacute], J. Librero, et al. (2003). 
``Accuracy of Pharmaceutical Advertisements in Medical Journals,'' 
Lancet, vol. 361(9351), pp. 27-32.
12. Cooper, R.J. and D.L. Schriger. (2005). ``The Availability of 
References and the Sponsorship of Original Research Cited in 
Pharmaceutical Advertisements,'' Canadian Medical Association 
Journal, vol. 172(4), pp. 487-491.
13. Jureidini, J.N., L.B. McHenry, and P.R. Mansfield. (2008). 
``Clinical Trials and Drug Promotion: Selective Reporting of

[[Page 11542]]

Study 329,'' International Journal of Risk & Safety in Medicine, 
vol. 20(1-2), pp. 73-81.
14. Garcia-Retamero, R. and M. Galesic. (2010). ``Who Profits From 
Visual Aids: Overcoming Challenges in People's Understanding of 
Risks,'' Social Science & Medicine, vol. 70(7), pp. 1019-1025.
15. Cooper, R.J., D.L. Schriger, R.C. Wallace, et al. (2003). ``The 
Quantity and Quality of Scientific Graphs in Pharmaceutical 
Advertisements,'' Journal of General Internal Medicine, vol. 18(4), 
pp. 294-297.
16. Sah, S. and A. Fugh-Berman. (2013). ``Physicians Under the 
Influence: Social Psychology and Industry Marketing Strategies,'' 
The Journal of Law, Medicine & Ethics, vol. 41(3), pp. 665-672. doi: 
10.1111/jlme.12076.

    Dated: March 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-05235 Filed 3-14-18; 8:45 am]
 BILLING CODE 4164-01-P


