Presenting Quantitative 
Efficacy and Risk 
Information in  
Direct-to-Consumer (DTC) 
Promotional Labeling and 
Advertisements 
 
Guidance for Industry
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
Center for Biologics Evaluation and Research (CBER)  
Center for Veterinary Medicine (CVM)  
 
December 2023 
Advertising 
Revision 1 
 
OMB Control Number 0910-0686  
Current expiration date available at https://www.reginfo.gov 
(Search ICR and enter OMB control number) 
 
See additional PRA statement in section IV of this guidance.   
 
 
56628108fnlrv1.docx   
Presenting Quantitative 
Efficacy and Risk Information 
in Direct-to-Consumer (DTC) 
Promotional Labeling and 
Advertisements  
Guidance for Industry 
 
Additional copies are available from: 
Office of Communications, Division of Drug Information  
Center for Drug Evaluation and Research 
Food and Drug Administration 
10001 New Hampshire Ave., Hillandale Bldg., 4th Floor  
Silver Spring, MD 20993-0002  
Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353 
Email: druginfo@fda.hhs.gov 
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs  
and/or 
Office of Communication, Outreach and Development  
Center for Biologics Evaluation and Research 
 Food and Drug Administration 
10903 New Hampshire Ave., Bldg. 71, Room 3128 
Silver Spring, MD 20993-0002 
Phone: 800-835-4709 or 240-402-8010 
Email: ocod@fda.hhs.gov 
https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances     
and/or 
Policy and Regulations Staff, HFV-6 
Center for Veterinary Medicine 
Food and Drug Administration 
7500 Standish Place, Rockville, MD  20855 
https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
Center for Biologics Evaluation and Research (CBER)  
Center for Veterinary Medicine (CVM)  
 
December 2023 
Advertising 
Revision 1 
  Contains Nonbinding Recommendations 
 
TABLE OF CONTENTS 
 
 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  BACKGROUND ............................................................................................................... 2 
III.  RECOMMENDATIONS FOR PRESENTING QUANTITATIVE EFFICACY AND 
RISK INFORMATION IN DIRECT-TO-CONSUMER PROMOTIONAL LABELING 
AND ADVERTISEMENTS ..................................................................................................... 3 
A.  Quantitative Efficacy or Risk Information From the Control Group ...................................... 3 
B.  Probability Presentations .............................................................................................................. 4 
1. Absolute Frequencies and Percentages ........................................................................................... 4 
2. Relative Frequencies ........................................................................................................................ 5 
C.  Formatting Quantitative Efficacy or Risk Information ............................................................. 6 
D.  Visual Aids ...................................................................................................................................... 8 
IV.  PAPERWORK REDUCTION ACT OF 1995 ................................................................ 9 
REFERENCES ............................................................................................................................ 11 
  Contains Nonbinding Recommendations 
 
Presenting Quantitative Efficacy and Risk Information in Direct-to- 
Consumer (DTC) Promotional Labeling and Advertisements 
Guidance for Industry1 
 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on 
this topic.  It does not establish any rights for any person and is not binding on FDA or the public.  You 
can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.  
To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the 
title page.   
 
 
 
 
I.  INTRODUCTION  
 
This guidance provides recommendations for presenting quantitative efficacy and risk 
information2 in direct-to-consumer (DTC) promotional labeling and advertisements for 
prescription human drug and biological products and prescription animal drugs and in DTC 
promotional labeling for  nonprescription animal drugs3 (collectively, promotional 
communications).4  For the purposes of this guidance, quantitative efficacy and risk information 
refers to information that numerically addresses the likelihood or magnitude of a drugs efficacy 
or risks. 
 
 
1 This guidance has been prepared by the Office of Prescription Drug Promotion in the Center for Drug Evaluation 
and Research in consultation with the Center for Biologics Evaluation and Research and the Center for Veterinary 
Medicine at the Food and Drug Administration.  You may submit comments on this guidance at any time.  Submit 
comments to Docket No. FDA-2018-D-2613 (available at https://www.regulations.gov/docket/FDA-2018-D-2613). 
 
2 While this guidance focuses on quantitative presentations of efficacy and risk information, firms may wish to refer 
to the principles and recommendations for quantitative presentations of other product benefits (keeping in mind that 
any such presentation of other product benefits otherwise must comply with applicable statutory and regulatory 
requirements).  
 
3 The term drugs in this guidance refers to prescription human drug and biological products and to prescription and 
nonprescription (veterinary feed directive (VFD) and over-the-counter) animal drugs.  
 
4 Promotional labeling is generally any labeling other than the FDA-required labeling.  Promotional labeling can 
include printed, audio, or visual matter descriptive of a drug that is disseminated by or on behalf of that drugs 
manufacturer, packer, or distributor (21 CFR 202.1(l)(2)).  The Federal Food, Drug, and Cosmetic Act (FD&C Act) 
does not define what constitutes an advertisement for a prescription drug, but FDA regulations provide several 
examples (21 CFR 202.1(l)(1)). 
  1  Contains Nonbinding Recommendations 
 
The guidance outlines FDAs recommendations for how firms5 that include quantitative efficacy 
or risk information in DTC promotional communications for their drugs can make the language 
and presentation more consumer-friendly.6  The guidance covers the following topics:  
   
  Providing quantitative efficacy or risk information for the control group, when applicable 
 
  Presenting probability information in terms of absolute frequencies, percentages, and 
relative frequencies 
 
  Formatting quantitative efficacy or risk information  
 
  Using visual aids to illustrate quantitative efficacy or risk information 
 
In general, FDAs guidance documents do not establish legally enforceable responsibilities.  
Instead, guidances describe the Agencys current thinking on a topic and should be viewed only 
as recommendations, unless specific regulatory or statutory requirements are cited. The use of 
the word should in Agency guidances means that something is suggested or recommended, but 
not required. 
 
 
II.  BACKGROUND 
 
Under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDAs implementing 
regulations, drug promotional labeling and prescription drug advertising must be truthful and 
non-misleading, convey information about the drugs efficacy and its risks in a balanced manner, 
and reveal material facts about the drug.7  Firms generally have flexibility with respect to the 
presentation of efficacy and risk information about their products as long as the presentation is 
not false or misleading and complies with other applicable statutory and regulatory requirements.  
When firms develop DTC promotional communications, they should consider how to best 
convey information about a drugs efficacy and risks so the audience understands the 
information.  This includes consideration of whether to provide efficacy and risk information by 
using words, numbers, or visual aids, or a combination of these elements.   
 
 
5 The term firms in this guidance refers to manufacturers, packers, and distributors of prescription drugs (as 
described in this guidance) and nonprescription animal drugs, including their representatives.  
  
6 This guidance is not intended to describe whether or when a presentation of quantitative efficacy or risk 
information would be truthful or non-misleading.  FDA reminds firms that they are responsible for ensuring that 
their promotional materials are truthful and non-misleading and that they comply with applicable statutory and 
regulatory requirements.  See, for example, sections 201(n) and 502(a) and (n) of the FD&C Act (21 U.S.C. 321(n), 
352(a) and (n)); 21 CFR 1.21(a) and 202.1(e)(5).  Additionally, we note that there may be ways other than the 
recommendations provided in this guidance that would make presentations of quantitative efficacy or risk 
information consumer-friendly. 
 
7 See sections 201(n) and 502(a) and (n) of the FD&C Act (21 U.S.C. 321(n), 352(a) and (n)); 21 CFR 1.21(a) and 
202.1(e)(5). 
  2  Contains Nonbinding Recommendations 
 
FDA has observed an increase in quantitative presentations of efficacy and risk information in 
DTC promotional communications submitted to the Agency.  Research on the communication of 
treatment information suggests that consumers can recall and comprehend efficacy and risk 
information when it is provided quantitatively (Buchter et al. 2014; ODonoghue et al. 2014b; 
Schwartz et al. 2007; Schwartz et al. 2009; Sullivan et al. 2015; Sullivan et al. 2019; Trevena et 
al. 2013; West et al. 2013; Woloshin et al. 2004).  When compared to qualitative descriptions of 
efficacy and risk information, quantitative information can improve consumers accuracy in 
estimating the drugs benefits and risks (Sullivan et al. 2015; West et al. 2013).  This is due in 
part to how consumers differ in their interpretations of qualitative descriptors (e.g., rare, 
common, most) and how the context in which qualitative terms are presented can affect how 
consumers understand them (Buchter et al. 2014; Fagerlin et al. 2007; Lipkus 2007; Visschers et 
al. 2009).  Quantitative efficacy or risk information may offer more precision than qualitative 
information; therefore, consumers can use quantitative efficacy and risk information to form 
more accurate perceptions about the drug (Lipkus 2007). 
 
DTC promotional communications containing quantitative efficacy or risk information should be 
accurate and understandable.  FDA recognizes that firms may experience challenges when 
determining how to present this kind of quantitative information in DTC promotional 
communications.  For these reasons, FDA is issuing this guidance to provide recommendations 
for presenting quantitative efficacy and risk information in DTC promotional communications 
and to encourage firms to follow these recommendations when including such information in 
their DTC promotional communications.   
 
The recommendations in this guidance generally apply to quantitative efficacy and risk 
presentations in DTC promotional communications across various media types (e.g., print, 
electronic, audiovisual).  Firms should consider the amount of space or time available and any 
other factors specific to the media type in which their presentation will appear when determining 
how to present quantitative efficacy or risk information in their DTC promotional 
communications so that consumers have an opportunity to attend to and understand it.  
 
The examples in this guidance are intended to illustrate recommended approaches to presenting 
quantitative efficacy and risk information in DTC promotional communications.  Each example 
is meant to address a specific concept described in the guidance; a given example may not 
illustrate every recommendation outlined.  The examples do not encompass every potential 
promotional scenario or consideration and do not necessarily reflect an evaluation of a complete 
promotional piece, including whether the piece complies with other applicable requirements.  All 
recommendations discussed in this guidance should be taken into consideration even if not 
expressly illustrated in an example. 
 
 
III.  RECOMMENDATIONS FOR PRESENTING QUANTITATIVE EFFICACY AND 
RISK INFORMATION IN DIRECT-TO-CONSUMER PROMOTIONAL 
LABELING AND ADVERTISEMENTS 
 
A.  Quantitative Efficacy or Risk Information From the Control Group 
 
  3  Contains Nonbinding Recommendations 
 
When a study includes a control group, firms that provide quantitative efficacy or risk 
information about a drug in DTC promotional communications should provide quantitative 
information from both the treatment group and the relevant control group.  Information from the 
control group plays an important role in evaluating a drugs benefits and risks (ODonoghue et 
al. 2014a).  Including quantitative benefit or risk measures observed in the control group when 
providing corresponding quantitative measures observed in the treatment group improves 
consumers ability to process and comprehend the drugs benefits and risks and can lead to more 
informed decision making (ODonoghue et al. 2014a; Schwartz et al. 2009).  Research suggests 
that consumers can use the information about the control group to form accurate perceptions 
about a drugs benefits (including efficacy) and risks (ODonoghue et al. 2014a; Schwartz et al. 
2009; Sullivan et al. 2013).  Promotional communications that include control group information 
should accurately describe the comparator used in the control group.   
 
Example8 1:  In a clinical trial of 173 participants, 68% of patients who were treated with Drug 
X plus a sulfonylurea experienced a reduction in blood glucose levels, while 33% 
of patients treated with a sulfonylurea alone experienced a reduction in blood 
glucose levels.   
 
    The firm is developing a social media web page for Drug X and includes a 
presentation that 68% of patients treated with Drug X plus a sulfonylurea 
experienced a reduction in blood glucose levels.   
 
    To improve consumers ability to comprehend the drugs effect on blood glucose 
levels, the firm should also include that 33% of patients treated with a 
sulfonylurea alone experienced a reduction in blood glucose levels.  
 
B.  Probability Presentations 
 
Firms should consider the following recommendations when presenting quantitative probability 
information about their drugs efficacy and risks.  
 
1.  Absolute Frequencies and Percentages 
 
Firms presenting quantitative efficacy or risk probabilities in DTC promotional communications 
should convey the information in terms of absolute frequencies (e.g., 57 out of 100) or 
percentages (57%).  Research suggests that using these formats to express probabilities when 
communicating health information can improve consumers comprehension and ability to recall 
the information (Lipkus 2007; Zipkin et al. 2014).  Additionally, consumers receiving 
information about a drugs efficacy and risk rates in terms of absolute frequencies or percentages 
can more easily process and evaluate the information than when the same information is in a 
format that requires them to perform a calculation to interpret the probabilities (Lipkus 2007; 
ODonoghue et al. 2014b; Sullivan et al. 2015).   
 
 
8 Each of the examples in this guidance is intended to stand on its own, and the use of Drug X represents a 
different fictitious drug in each example. 
  4  Contains Nonbinding Recommendations 
 
Example 2:  A firm is developing a magazine advertisement and includes a presentation 
showing that in clinical trials, most patients experienced a response after 
  12 weeks of treatment with Drug X.    
 
  The firm wants to add numeric values to the presentation to help consumers 
understand this information.   
 
  To communicate this information in a manner that will facilitate consumer 
comprehension, the firm presents the information as an absolute frequency:  In a 
clinical trial, 78 out of 100 patients experienced a response after 12 weeks of 
treatment with Drug X, compared to 20 out of 100 patients on placebo. 
   
Example 3:    A firm plans to include quantitative information in a patient mailer for Drug X 
about the most common adverse reaction reported in its clinical trial that 
compared Drug X to Drug Y:  nausea.   
 
To allow consumers to easily process this information, the firm presents the 
information as a percentage:  In a clinical trial, 45% of patients experienced 
nausea during 20 weeks of treatment with Drug X, compared to 18% of patients 
during treatment with Drug Y.    
 
2.  Relative Frequencies 
 
Research suggests that consumers do not understand relative frequencies (e.g., 33% reduction in 
symptoms; 3 times as likely to experience a side effect) in health communications as easily as 
they understand other formats for presenting probabilities, such as absolute frequencies or 
percentages (Covey 2007; Fagerlin et al. 2007; Zipkin et al. 2014).  Consumers may also find the 
efficacy or risk probability described as a relative frequency harder to comprehend and more 
favorable as compared to the absolute frequency, which could lead to consumers over- or 
underestimating how well the drug works or the magnitude of the risk associated with the drug 
(Ancker et al. 2006; Covey 2007; Zipkin et al. 2014).  
 
If firms choose to present efficacy or risk probabilities as relative frequencies, they should add 
context to the relative frequency presentation to improve consumers ability to accurately 
understand the efficacy or risk information.  Specifically, firms should include the corresponding 
absolute probability measures in presentations of relative frequency measures to provide the 
information in a way that does not require further calculation about the effect being 
communicated (Covey 2007; ODonoghue et al. 2014b; Sullivan et al. 2015).  Firms should 
present the absolute probability measure prominently and in direct conjunction with the relative 
frequency measure.   
 
Example 4:    A firm is developing a DTC television advertisement for Drug X, which is 
indicated to reduce the risk of stroke.  In a clinical trial, the following absolute 
risk reductions were observed:  1% of patients treated with Drug X had a stroke, 
compared to 2% of patients in the control group.  This represents a 50% relative 
reduction in risk of stroke.   
  5  Contains Nonbinding Recommendations 
 
 
  The firm wants to include this information in the DTC television advertisement. 
 
To communicate this information in the DTC television advertisement in a 
manner that will facilitate consumer comprehension, the firm presents the 
absolute risk percentages in direct conjunction with the 50% relative risk 
reduction information and with equal prominence:  In a clinical trial, Drug X 
reduced the risk of stroke by 50% (1% of patients treated with Drug X had a 
stroke, compared to 2% of patients in the control group).  
 
C.  Formatting Quantitative Efficacy or Risk Information 
 
Firms that provide quantitative efficacy or risk information about their drugs in DTC 
promotional communications should incorporate the following formatting recommendations: 
 
  Present the information in the same numerical format throughout a promotional 
communication (Lipkus 2007; Trevena et al. 2013).  For example, firms providing two 
probabilities about two efficacy outcomes should provide both probabilities as absolute 
frequencies or provide both probabilities as percentages.  Firms should also consistently 
characterize efficacy or risk information quantitatively throughout a promotional piece, 
rather than alternating between qualitative descriptors and quantitative information to 
describe similar information or concepts.  
  
  Use frequencies with the same denominator when providing more than one absolute 
frequency and consider using denominators that are multiples of 10 (Fagerlin et al. 2007; 
Lipkus 2007; Trevena, et al. 2013; Visschers et al. 2009).  
 
  Express probabilities using whole numbers to the extent that the probabilities in whole 
numbers accurately reflect the numerical value being described in the promotional piece 
(Lipkus 2007; Zipkin et al. 2014).9  Where a whole number would not be appropriate, 
firms should express the value as is (e.g., as a decimal) instead of rounding the value up 
or down to the nearest whole number.  For example, firms should not round probabilities 
less than 1 to the nearest whole number.  Similarly, firms should not round probabilities 
to the nearest whole number when comparing probabilities that are so close in value that 
the difference between the probabilities would be lost if the values were expressed as a 
whole number or numbers.   
 
  Promotional communications should present quantitative probability information about a 
particular risk in a manner that does not minimize or detract from information about the 
severity of the risk.  Promotional communications should avoid presentations that focus 
attention on the low probability of a serious risk occurring, that characterize the 
 
9 For values greater than 1, to express a value to the nearest whole number, the following principles should be 
followed:  For amounts falling exactly halfway between two whole numbers or higher (e.g., 2.5 to 2.99), round up 
(i.e., 3); for values less than halfway between two whole numbers (e.g., 2.01 to 2.49), round down (i.e., 2). 
  6  Contains Nonbinding Recommendations 
 
probability of that risk occurring as insignificant, or that otherwise suggest that the risk is 
not important based on its probability of occurring. 
  
Example 5:    A firm is developing a consumer brochure for Drug X and is considering whether 
to describe quantitative information about moderate symptom relief in patients 
treated with Drug X and treated with placebo in terms of absolute frequencies (9 
out of 10 and 3 out of 10, respectively) or as percentages (90% and 30%, 
respectively).  
 
Although either probability measure would be appropriate to describe these 
outcomes, to help consumers process the information, the firm should provide the 
outcomes for both the treatment and placebo groups in the same format (i.e., both 
outcomes as absolute frequencies or both outcomes as percentages):  In patients 
treated with Drug X, 9 out of 10 patients experienced moderate symptom relief, 
compared to 3 out of 10 patients who received placebo.  Alternatively:  In 
patients treated with Drug X, 90% of patients experienced moderate symptom 
relief, compared to 30% of patients who received placebo.   
 
Example 6:    In a clinical trial for Drug X, 54% of patients treated with Drug X experienced 
moderate symptom relief and 19% of patients treated with Drug X experienced 
complete symptom relief, compared to 28% of patients treated with placebo and 
2% of patients treated with placebo, respectively.   
 
  The firm is developing a patient booklet for Drug X that contains the following 
information:  In a clinical trial, the majority of patients experienced moderate 
symptom relief after treatment with Drug X, and 19% of patients experienced 
complete symptom relief.  In patients treated with placebo, less than half of 
patients experienced moderate symptom relief and 2% of patients experienced 
complete symptom relief. 
 
To present the information consistently, the firm should include the majority of 
patients (54%) and less than half of patients (28%) in the proposed patient 
booklet.  Alternatively, the firm could consistently present only the quantitative 
information throughout the piece (e.g., ...54% of patients treated with Drug X 
experienced moderate symptom relief..., ...28% of patients treated with placebo 
experienced moderate symptom relief...). 
 
Example 7:    According to the FDA-approved labeling for Drug X, 2% of clinical trial  
participants on Drug X experienced bleeding that required hospitalization.   
 
In its promotional communications for Drug X, the firm includes the statement, 
In a clinical trial, only 2% of patients experienced bleeding that required 
hospitalization.  
 
By including the qualifier only in the description of the percentage of patients 
who experienced bleeding that required hospitalization, the presentation 
  7  Contains Nonbinding Recommendations 
 
characterizes the percentage of patients who experienced this risk in a way that 
could suggest it is not important and may also undermine audience understanding 
of the serious nature of the risk.  To avoid these possibilities, the firm should 
revise this presentation to remove the qualifier only.  
 
D.  Visual Aids 
 
When DTC promotional communications contain quantitative efficacy or risk information, visual 
aids such as graphs, tables, and icon arrays are often used to illustrate the information and put the 
numerical values in context.  Visual representations of efficacy and risk in DTC promotional 
communications improve consumer comprehension of numeric values by illustrating patterns, 
summarizing the data, and reducing the amount of mental calculations the consumer must 
perform to extract meaning from the quantitative information (Ancker et al. 2006; Fagerlin et al. 
2007; Lipkus 2007).  Moreover, visual aids can improve consumers ability to accurately 
understand how well a drug works and support decision making (Fagerlin et al. 2007; Garcia-
Retamero and Cokely 2013; Sullivan et al. 2016; Zipkin et al. 2014).   
 
Visual aids in DTC promotional communications help consumers comprehend quantitative 
efficacy and risk information, but all visual aid designs are not equally effective in conveying all 
types of information (Fagerlin et al. 2007; Sullivan et al. 2016).  Therefore, we recommend that 
firms select the visual aid design that best communicates the quantitative efficacy or risk 
information being presented.  When choosing a visual aid to express quantitative efficacy or risk 
information about a drug, firms should carefully consider the communications purpose and 
objectives (Ancker et al. 2006; Fagerlin et al. 2007).  For example, a bar graph is an appropriate 
format for visually depicting comparisons between probabilities, whereas a line graph is more 
useful for illustrating trends or changes over time (Ancker et al. 2006; Fagerlin et al. 2007; 
Lipkus 2007).  Additionally, firms should consider the following general recommendations when 
designing visual aids to illustrate quantitative efficacy or risk information in their DTC 
promotional communications: 
 
  Explain the purpose of the visual aid clearly and accurately, and define the elements 
displayed (Garcia-Retamero and Cokely 2013; Lipkus 2007).  For example, firms should 
include a title, header, or caption (written or oral depending on the media) and identify 
the visual aids variables, scales, and axes (when applicable). 
 
  Make visual displays of numeric information proportionate to the quantity being 
described and ensure the scaling of axes is appropriate to accurately represent effect sizes 
(Ancker et al. 2006; Lipkus 2007).  For example, the height of each bar on a vertical bar 
graph should be proportionate to the numerical value it represents and the scaling of the y 
axis should ensure the difference in heights between bars is proportional to the difference 
in value. 
 
  Include visual representations of both the numerator and denominator of ratios or 
frequencies (Ancker et al. 2006).  For example, an icon array, graph, or other visual aid 
depicting an absolute frequency should represent the people who experienced the effect 
  8  Contains Nonbinding Recommendations 
 
(numerator) and the total people studied (denominator).  When possible, firms should 
also consider illustrating the denominator as a multiple of 10 in the display.   
 
Example 8:   Drug X is used to treat a serious condition.  Infection is a risk associated with the 
use of Drug X.   
 
  The firm intends to include a visual aid on Drug Xs consumer website to 
communicate information from Drug Xs FDA-approved labeling about the 
percentage of patients who experienced a mild to moderate infection and those 
who experienced a severe to life-threatening infection after treatment with Drug X 
compared to patients treated with placebo.     
 
The firm prepares a bar graph to present this information because it facilitates 
the comprehension of visual comparisons between probabilities.  As illustrated 
below, the firm includes a title that describes what the bar graph portrays, labels 
the scales and variables, does not truncate the y axis, and ensures that the values 
graphically displayed are proportionate to the quantities being described.  
 
 
 
 
IV.  PAPERWORK REDUCTION ACT OF 1995 
 
This guidance contains information collection provisions that are subject to review by the Office 
of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 
3501-3521).   
  9  Contains Nonbinding Recommendations 
 
 
The time required to complete this information collection is estimated to average 2 hours per 
response, including the time to review instructions, search existing data sources, gather the data 
needed, and complete and review the information collection.  Send comments regarding this 
burden estimate or suggestions for reducing this burden to: 
 
Office of Prescription Drug Promotion, Center for Drug Evaluation and Research, Food 
and Drug Administration, 10903 New Hampshire Avenue, Bldg. 51, Silver Spring, MD 
20993-0002. 
 
This guidance also refers to previously approved FDA collections of information.  The 
collections of information in 21 CFR 202.1 have been approved under OMB control number 
0910-0686. 
 
An Agency may not conduct or sponsor, and a person is not required to respond to, a collection 
of information unless it displays a currently valid OMB control number.  The OMB control 
number for this information collection is 0910-0686.  The current expiration date is available at 
https://www.reginfo.gov (search ICR and enter OMB control number).   
  10  Contains Nonbinding Recommendations 
 
REFERENCES 
 
Ancker, JS, Y Senathirajah, R Kukafka, and JB Starren, 2006, Design Features of Graphs in 
Health Risk Communication: A Systematic Review, J Am Med Inform Assoc, 13(6):608618. 
 
Buchter, RB, D Fechtelpeter, M Knelangen, M Ehrlich, and A Waltering, 2014, Words or 
numbers? Communicating Risk of Adverse Effects in Written Consumer Health Information: A 
Systematic Review and Meta-Analysis, BMC Med Inform Decis Mak, 14:76. 
 
Covey J, 2007, A Meta-Analysis of the Effects of Presenting Treatment Benefits in Different 
Formats, Med Decis Making, 27(5):638654. 
 
Fagerlin, A, PA Ubel, DM Smith, and BJ Zikmund-Fisher, 2007, Making Numbers Matter: 
Present and Future Research in Risk Communication, Am J Health Behav, 31(Suppl 1):S4756. 
 
Garcia-Retamero, R and ET Cokely, 2013, Communicating Health Risks with Visual Aids, Curr 
Dir Psychol Sci, 22(5):392399. 
 
Lipkus, IM, 2007, Numeric, Verbal, and Visual Formats of Conveying Health Risks: Suggested 
Best Practices and Future Recommendations, Med Decis Making, 27(5):696713. 
 
ODonoghue, AC, HW Sullivan, and KJ Aikin, 2014a, Randomized Study of Placebo and 
Framing Information in Direct-to-Consumer Print Advertisements for Prescription Drugs, Ann 
Behav Med, 48(3):311322.  
 
O'Donoghue, AC, HW Sullivan, KJ Aikin, D Chowdhury, RR Moultrie, and DJ Rupert, 2014b, 
Presenting Efficacy Information in Direct-to-Consumer Prescription Drug Advertisements, 
Patient Educ Couns, 95(2):271280.  
 
Schwartz, LM, S Woloshin, and HG Welch, 2007, The Drug Facts Box: Providing Consumers 
with Simple Tabular Data on Drug Benefit and Harm, Med Decis Making, 27:655662. 
 
Schwartz, LM, S Woloshin, and HG Welch, 2009, Using a Drug Facts Box to Communicate 
Drug Benefits and Harms: Two Randomized Trials, Ann Intern Med, 150(8):516527. 
 
Sullivan, HW, AC ODonoghue, and KJ Aikin, 2013, Presenting Quantitative Information About 
Placebo Rates to Patients, JAMA Intern Med, 173(21):20062007.  
 
Sullivan, HW, AC ODonoghue, and KJ Aikin, 2015, Communicating Benefit and Risk 
Information in Direct-to-Consumer Print Advertisements: A Randomized Study, Ther Innov 
Regul Sci, 49(4):493502.   
 
Sullivan, HW, AC ODonoghue, KJ Aikin, D Chowdhury, RR Moultrie, and DJ Rupert, 2016, 
Visual Presentations of Efficacy Data in Direct-to-Consumer Prescription Drug Print and 
Television Advertisements: A Randomized Study, Patient Educ Couns, 99:790799.  
 
  11  Contains Nonbinding Recommendations 
 
Sullivan, HW, AC ODonoghue, M Lynch, Mihela Johnson, C Davis, and DJ Rupert, 2019, The 
Effect of Including Quantitative Information on Multiple Endpoints in Direct-to-Consumer 
Prescription Drug Television Advertisements, Med Decis Making, 39(8):975985.   
 
Trevena, LJ, BJ Zikmund-Fisher, A Edwards, W Gaissmaier, M Galesic, PKJ Han, J King, ML 
Lawson, SK Linder, I Lipkus, E Ozanne, E Peters, D Timmermans, and S Woloshin, 2013, 
Presenting Quantitative Information About Decision Outcomes: A Risk Communication Primer 
for Patient Decision Aid Developers, BMC Med Inform Decis Mak, 13(Supple 2):S7. 
 
Visschers, VH, RM Meertens, WW Passchier, NN De Vries, 2009, Probability Information in 
Risk Communication: A Review of the Research Literature, Risk Anal, 29(2):267287. 
 
West, SL, LB Squiers, L McCormack, BG Southwell, ES Brouwer, M Ashok, L Lux, V 
Boudewyns, A O'Donoghue, and HW Sullivan, 2013, Communicating Quantitative Risks and 
Benefits in Promotional Prescription Drug Labeling or Print Advertising, Pharmacoepidemiol 
Drug Saf, 22(5):447458. 
 
Woloshin, S, LM Schwartz, and HG Welch, 2004, The Value of Benefit Data in Direct-to-
Consumer Drug Ads, Health Aff, Suppl Web Exclusives, W4:234245. 
 
Zipkin, DA, CA Umscheid, NL Keating, E Allen, K Aung, R Beyth, S Kaatz, DM Mann, JB 
Sussman, D Korenstein, C Schardt, A Nagi, R Sloane, and DA Feldstein, 2014, Evidence-Based 
Risk Communication: A Systematic Review, Ann Intern Med, 161(4):270280.  
  12