[Federal Register Volume 85, Number 182 (Friday, September 18, 2020)]
[Notices]
[Pages 58366-58370]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-20614]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1644]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Medical Conference Attendees' Observations about 
Prescription Drug Promotion

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) 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 and to 
allow 60 days for public comment in response to the notice. This notice 
solicits comments on a proposed study entitled ``Medical Conference 
Attendees' Observations about Prescription Drug Promotion.''

DATES: Submit either electronic or written comments on the collection 
of information by November 17, 2020.

[[Page 58367]]


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 November 17, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of November 17, 2020. 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-2020-N-1644 for ``Medical Conference Attendees' Observations about 
Prescription Drug Promotion.'' Received comments, those filed in a 
timely manner (see ADDRESSES), will be placed 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, 240-402-7500.
     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.govinfo.gov/content/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, 240-402-7500.

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, 
Ila.Mizrachi@fda.hhs.gov.
    For copies of the questionnaire contact: Office of Prescription 
Drug Promotion (OPDP) Research Team, DTCResearch@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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.

Medical Conference Attendees' Observations About 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 the FDA to conduct research relating to health 
information. Section 1003(d)(2)(C) of the Federal Food, Drug, and 
Cosmetic Act (the 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 Office of Prescription Drug Promotion's (OPDP) mission is to 
protect the public health by helping to ensure that prescription drug 
promotion is truthful, balanced, and accurately communicated. OPDP's 
research program provides scientific evidence to help ensure that our 
policies related to prescription drug promotion will have the greatest 
benefit to public health. Toward that end, we have consistently 
conducted research to evaluate the

[[Page 58368]]

aspects of prescription drug promotion that are most central to our 
mission. Our research focuses in particular on three main topic areas: 
(1) Advertising features, including content and format; (2) target 
populations; and (3) research quality. Through the evaluation of 
advertising features we assess how elements such as graphics, format, 
and disease and product characteristics impact the communication and 
understanding of prescription drug risks and benefits. Focusing on 
target populations allows us to evaluate how understanding of 
prescription drug risks and benefits may vary as a function of 
audience. Our focus on research quality aims at maximizing the quality 
of our research data through analytical methodology development and 
investigation of sampling and response issues. This study will inform 
the first and second topic areas: Advertising features and target 
populations.
    Because we recognize the strength of data and the confidence in the 
robust nature of the findings is improved through the results of 
multiple converging studies, we continue to develop evidence to inform 
our thinking. We evaluate the results from our studies within the 
broader context of research and findings from other sources, and this 
larger body of knowledge collectively informs our policies as well as 
our research program. Our research is documented on our homepage, which 
can be found at: https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm090276.htm. The website 
includes links to the latest Federal Register notices and peer-reviewed 
publications produced by our office. The website maintains information 
on studies we have conducted, dating back to a survey of direct-to-
consumer (DTC) advertising conducted in 1999.
    The current study focuses on understanding the landscape of 
healthcare provider (HCP)-directed promotion of prescription drugs at 
medical conferences in general and, more specifically, how elements of 
pharmaceutical booths in medical conference exhibit halls impact HCP 
attendees' perceptions of the drugs that are promoted at those booths. 
We will first ask attendees, who are prescribers within different 
disciplines (primary care physicians, specialists, nurse practitioners, 
and physician assistants), general questions about their attendance at 
medical conferences, including: (1) Questions about their motivations 
for attending, (2) activities they participate in (e.g., symposia, 
poster sessions, social events, exhibit halls), and (3) their opinions 
about the prescription drug treatments promoted at medical conferences. 
These questions will allow us to capture the viewpoint of prescribers 
who attend medical conferences where prescription treatments are 
discussed and promoted.
    The second part of our study will allow us to get more detailed 
information about interactions in medical conference exhibit halls. A 
2006 study found that at least 80 percent of physicians attended at 
least 1 medical conference each year and spent an average of 7 hours on 
the exhibit hall floor at each event (Ref. 1). The length of time spent 
at each booth--between 12 and 21 minutes (Ref. 1)--was comparatively 
longer than detailing visits in HCP offices, which range from 5 to 10 
minutes on average (Refs. 2 and 3). Thus, medical conference exhibit 
booths provide opportunities for pharmaceutical companies to market to 
large numbers of HCPs and potentially engage in more lengthy 
interactions.
    Promotional booths for prescription drugs and the promotional 
materials disseminated at those booths fall within the regulatory 
purview of OPDP. As with other promotional materials for prescription 
drugs, pharmaceutical companies may voluntarily submit draft versions 
of their exhibit panels and exhibit materials for FDA review (Ref. 4). 
This study is designed to provide insights to inform the advisory 
comments that OPDP provides to pharmaceutical companies that 
voluntarily seek FDA review. OPDP also monitors prescription drug 
promotional booths and materials as part of its surveillance program. 
Recent compliance letters issued by OPDP described booth or panel 
displays that communicated misleading information regarding drug 
efficacy and safety, provided insufficient information on drug risks, 
and omitted ''material facts'' about the promoted drug (Ref. 5). A 
primary reason that physicians and other medical professionals report 
visiting specific exhibitors at conferences is to obtain product 
information (Ref. 1), and it is important that the information provided 
by exhibitors to HCPs regarding the risks and efficacy of prescription 
medications not be misleading. Thus, investigating the impact of 
pharmaceutical booth promotions among medical conference attendees has 
valuable practical implications for the public health.
    As part of our specific exhibit booth research, we will simulate 
interactions that HCPs may have at medical conference booths promoting 
prescription drugs, so that FDA can examine the effects of the booth 
representative's background (scientist/medical professional versus 
business professional) and disclosure of data limitations (present 
versus absent). In a recent survey, HCP conference attendees reported 
that interacting with company representatives was the most important 
element of their booth visits, followed by the availability and quality 
of clinical information (Ref. 4). Thus, the perceived credibility of 
the booth representative and the availability of information on data 
limitations could ultimately inform HCPs' perceptions of the risks and 
benefits of drugs presented at exhibit booths and their decisions to 
prescribe drugs to patients.
    Indeed, literature suggests that credibility and disclosures are 
relevant elements to study in the context of prescription drug 
conference booths. Credibility is linked to extrinsic (physical 
attractiveness, power) and intrinsic (delivery factors, linguistic 
cues) factors. For example, one extrinsic feature of source credibility 
is similarity between the source and recipient. Research on the effects 
of source similarity has been mixed, but a classic field experiment by 
Brock in 1965 found that customers buying paint were more likely to 
follow recommendations of a salesperson they perceived as having 
painting experiences similar to their own (Ref. 6). More recent studies 
have examined the effects of endorsers with professional expertise 
versus those with product experience on attitudes toward the brand and 
promotion (Refs. 7 and 8). These past studies are relevant to our 
manipulations of booth representative background in this study given 
that representatives with a medical/science background may reflect 
professional expertise, whereas representatives with a business 
background may reflect product experience.
    There is little empirical evidence on the impact of disclosing data 
limitations during promotional detailing or other sales promotion. On 
one hand, providing important information (e.g., key limitations) about 
the data/drug should help increase comprehension and decrease 
inaccurate or unjustified interpretations of the data. On the other 
hand, seeing the disclosure of data limitations--essentially tempering 
the study findings and providing a sort of two-sided information that 
is not necessarily in favor of the drug's effects--may improve the 
material's credibility and appeal by signifying more transparency on 
the sponsor's part (Ref. 9), and therefore lead to greater interest in 
the drug (regardless of accurate comprehension). Conversely, not seeing 
any qualifying or clarifying information could raise red flags among

[[Page 58369]]

providers, resulting in the lowest levels of perceived credibility. 
Whether the booth representative has a medical/science background or 
business background may shape perceptions of credibility even further, 
thereby influencing HCPs' perceptions of the drug. Thus, while 
disclosure of data limitations and credibility of the booth 
representative may have independent effects on HCPs' comprehension and 
perceptions, these variables could also interact in their effects.

I. Research Questions

    With this background in mind, we plan to address the issue of how 
firms communicate about prescription drugs from the perspective of 
medical conference/exhibit hall attendees. Specifically, we will ask 
for attendees' general observations of:
    1. Disclosures or disclaimers accompanying exhibit hall 
presentations and/or symposia (about data limitations, contrary data, 
FDA approval status, financial/affiliation sponsorship, etc.);
    2. publications or references accompanying the presentation of 
information (PI for approved indications, contrary data references, 
etc.);
    3. what type of studies are being reported (real world evidence, 
pharmacokinetic/pharmacodynamic studies, meta-analyses, etc.).
    4. who makes the presentations (field of study, training); and
    5. where the presentations are made (poster session, scientific 
floor, exhibit hall).
    We will also address exhibit hall pharmaceutical booth 
interactions, specifically:
    1. How does the presence or absence of information about the 
limitations of data influence perceptions of the promoted product?
    2. How does the background of the booth representative influence 
perceptions of the promoted product?
    3. Do these two variables interact?

II. Method

    To complete this research, we will recruit attendees of large 
medical conferences in the United States over the course of 1 year. 
These conferences will represent a variety of specialties to reflect 
medical areas that have prescription treatments that may be promoted to 
HCPs. Specifically, we will enroll HCPs who attended one of 12 selected 
medical conferences into an online survey within 7 days of conference 
attendance. Exhibit 1 summarizes our approach to: (1) Determining the 
conference sampling frame; (2) determining the attendee sampling frame; 
and (3) recruiting and enrolling the target sample in the online 
survey.
[GRAPHIC] [TIFF OMITTED] TN18SE20.299

    In the first step, we will select conferences that focused on 
therapeutic areas that have the following attributes:
     High number of currently promoted branded medications;
     high volume of prescriptions written;
     large patient population; and
     high amount of new drug development and promotional 
spending.
    Table 1 shows the final criterion for conference inclusion. 
Conferences that meet these criteria will be selected based on an 
environmental scan.

                Table 1--Conference Eligibility Criteria
------------------------------------------------------------------------
               Criterion                            Parameters
------------------------------------------------------------------------
Therapeutic area.......................  Associated with one of the
                                          prioritized therapeutic areas.
Conference attendance..................  Estimated attendance of 5,000
                                          or more individuals.
Target audience........................  Focused on prescribers and
                                          clinicians (e.g., not
                                          insurers).
Event date.............................  Scheduled during August 2021--
                                          August 2022.
Event location.........................  Domestic (within United
                                          States).
------------------------------------------------------------------------

    Following conference selection, medical conference attendees at 
each conference will be randomly selected, invited to participate, and 
screened to ensure they are HCPs with prescribing authority who 
responded to the survey invitation within 7 days of attending the 
target conference. HCPs will be limited to physicians, nurse 
practitioners, and physician assistants who spend 20 percent or more 
time in direct patient care, are able to read and speak English, are 
not currently employed by the Federal government or a pharmaceutical 
company (not including occasional consulting), and have not 
participated in another wave of the project.

[[Page 58370]]

    The online survey will be broken into two main parts: (1) A cross-
sectional survey designed to capture HCP observations from the medical 
conference and (2) an experimental study designed to assess how data 
disclosures and exhibit booth representative background influence HCP 
perceptions of promoted prescription drugs. The cross-sectional part of 
the survey will contain a series of close- and open-ended questions. 
The experimental study part of the survey will ask participants to view 
a brief video simulating a conference exhibit hall interaction between 
an HCP attendee and a booth employee and then answer questions about a 
fictitious prescription drug featured in the video. Table 2 shows our 
proposed study design and sample size across 12 conferences.

              Table 2--Study Design and Target Sample Sizes
------------------------------------------------------------------------
                                              Booth employee
                                                background
                Disclosure                ----------------------  Total
                                            Business   Medical
------------------------------------------------------------------------
Present..................................     n = 92     n = 92      184
Absent...................................     n = 92     n = 92      184
    Total................................        184        184      368
------------------------------------------------------------------------

    FDA estimates the burden of this collection of information as 
follows:

                                 Table 3--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
           Activity                Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
\Screener\....................           \933\             \1\           \933\  \.08\ \(5                \74.64\
                                                                                 minutes)\.
\Pretest\.....................            \25\             \1\            \25\  \0.33\ \(20               \8.25\
                                                                                 minutes)\.
\Main test\...................           \368\             \1\           \368\  \0.33\ \(20             \121.44\
                                                                                 minutes)\.
                               ---------------------------------------------------------------------------------
    \Total\...................  ..............  ..............  ..............  ................        \204.33\
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

III. References

    The following references marked with an asterisk (*) are on display 
at 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 also are available electronically at https://www.regulations.gov. References without asterisks are not on public 
display at https://www.regulations.gov because they have copyright 
restriction. Some may be available at the website address, if listed. 
References without asterisks are available for viewing only at the 
Dockets Management Staff. 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. Mack, J. (March 2006). ``Effective Physician Marketing at Medical 
Meeting Exhibits.'' Pharma Marketing News, 5(3).
2. *Industry Standard Report (2014). ``Pharmaceutical Detailing: In-
Person vs. Electronic vs. Phone.'' Retrieved from https://www.isrreports.com/wp-content/uploads/2014/08/ISR-Pharmaceutical-Detailing-In-Person-vs.-Electronic-vs.-Phone-Preview-Aug2014.pdf.
3. Steinman, M. A., G. M. Harper, M. M. Chren, et al (April 2007). 
``Characteristics and Impact of Drug Detailing for Gabapentin.'' 
PLoS Med, 4(4), e134. http://dx.doi.org/10.1371/journal.pmed.0040134.
4. Adler, D., A. Sherman, and M. Walz (2017). ``Medical Conference 
Presence: Is it Worth it for Your Brand?'' Retrieved from https://www.pharmavoice.com/article/2017-9-medical-conferences/.
5. *FDA. Warning letters and notice of violation letters to 
pharmaceutical companies. Retrieved from https://www.fda.gov/drugs/enforcement-activities-fda/warning-letters-and-notice-violation-letters-pharmaceutical-companies.
6. Brock, T. C. (June 1965). ``Communicator-Recipient Similarity and 
Decision Change.'' Journal of Personality & Social Psychology, 1, 
650-654.
7. Braunsberger, K. and J. M. Munch (1998). ``Source Expertise 
Versus Experience Effects in Hospital Advertising.'' Journal of 
Services Marketing, 12(1), 23-38.
8. Siemens, J. C., S. Smith, D. Fisher, and T. D. Jensen, (2008). 
``Product Expertise Versus Professional Expertise: Congruency 
Between an Endorser's Chosen Profession and the Endorsed Product.'' 
Journal of Targeting, Measurement and Analysis for Marketing, 16(3), 
159-168.
9. Pechmann, C. (1992). ``Predicting When Two-Sided Ads Will be More 
Effective Than One-Sided Ads: The Role of Correlational and 
Correspondent Inferences.'' Journal of Marketing Research, 29(4), 
441-453.

    Dated: September 14, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-20614 Filed 9-17-20; 8:45 am]
BILLING CODE 4164-01-P


