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Presenting Risk Information Overview

Presenting Risk Information Overview

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Published by Dale Cooke
I prepared this overview of the 2009 FDA draft guidance on Presenting Risk Information several years ago. The guidance continues to be extremely relevant, and I thought others might be interested. This overview is not intended to replace reading the guidance itself, but is instead intended to help understanding the guidance.
I prepared this overview of the 2009 FDA draft guidance on Presenting Risk Information several years ago. The guidance continues to be extremely relevant, and I thought others might be interested. This overview is not intended to replace reading the guidance itself, but is instead intended to help understanding the guidance.

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Published by: Dale Cooke on Nov 14, 2011
Copyright:Attribution Non-commercial


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An Overview of FDA’s Guidance for Industry:Presenting Risk Information in Prescription Drug andMedical Device Promotion
What is a Guidance for Industry?
From the FDA website: “Guidance documents represent the Agency's current thinking on aparticular subject. They do not create or confer any rights for or on any person and do not operate tobind FDA or the public. An alternative approach may be used if such approach satisfies therequirements of the applicable statute, regulations, or both.”In other words, a guidance provides insight into how the FDA will interpret/enforce regulations, butthe Agency is not committed to following the exact specifications of a guidance. The agency is alsonot ruling out the possibility that there are alternative ways (different from those discussed in theguidance) to comply with the regulations. It is, of course, advisable to follow a guidance when theAgency issues one, and pharmaceutical companies do not deviate from guidances lightly.
What is the difference between a Draft Guidance and a Final Guidance?
A guidance for industry is first published as a “draft.” Within a specified period after being published,comments are accepted from the public (including industry professionals, advocacy groups,concerned citizens, etc.). After receiving that feedback, FDA will update the guidance and release itas final. Releasing a draft guidance does NOT commit FDA to producing a final guidance, and manydraft guidances have lingered in that state for years. Currently, the oldest draft guidance aboutadvertising on FDA’s website has a draft date of January 1999. Even when not finalized, guidancesare relied upon by industry because they provide the latest official comment from the agency aboutthe subject.
How well does current advertising present risk information?
In this guidance, the FDA cites some findings of their recent research, which is itself worthconsulting.K. Aikin, J. Swasy & A. Braman, Patient and Physician Attitudes and Behaviors AssociatedWith DTC Promotion of Prescription Drugs – Summary of FDA Survey Research Results,Final Report, November 19, 2004, available at:
According to this research, “60 percent of patients believe ads directed at them do not provideenough information about risks, 60 percent of physicians believe that patients have little or nounderstanding from these ads about what the possible risks and negative effects of the productsare, and 72 percent of physicians believe that patients have little or no understanding from theseads about who should not use the product.” (page 3)
The overarching principle for all evaluations of risk information is the principle of Fair Balance. Thisprinciple entails that the overall presentation of information about a prescription drug must fairlybalance the information about the benefits and risks of using a drug. This guidance makes clear thatin addition to looking at specific claims and corresponding risk-related statements, the FDA alsoconsiders the
net impression
of the piece as a whole. It is possible for every sentence/word to beappropriate while conveying overall less risk than FDA requires. There are two examples of suchfailure to present risk information appropriately presented in the guidance:
© 2009 Digitas Health Page 1 of 3
a.A TV spot with factually correct risk information superimposed on images of peopleenjoying the benefits of the drug. “In this case, the audio disclosure may not adequatelycommunicate risks because of the accompanying discordant visuals and distractingmusic.”b.Large, bolded prominent claims in a print ad accompanied by fine print disclosures of risk.
What does this Guidance imply should be done or avoided?
This guidance has a summary of the factors that govern the presentation of risk information. Below Ihave presented some of the factors that I consider most likely to affect presentation of riskinformation in digital contexts.
FDA emphasizes the importance of what is called “
.” Materiality is the relevanceand importance of risk information to a particular audience. The information that a particular drug should not be used by pregnant women is not material to me because I’m a man. Butinformation that the same drug might cause impotence or erectile dysfunction is material tome (though not to a pregnant woman).This guidance devotes significant space to the combined issues of materiality andcomprehensiveness (pages 11-14). Under the heading “Consideration of Target Audience”there is a summary of the requirements for presenting risk information, which I think providesa nice set of criteria to keep in mind regarding the success of any presentation of Fair Balance that we develop:“Consumer-directed communications should generally convey the following:— What the drug or device is used for — Who should or should not take a drug or use a device— What can be expected from a drug or device— What patients should ask their healthcare professionals about a drug or device— What patients should tell their healthcare professionals about before or whiletaking a drug or using a device” (page 12)Balancing the emphasis on materiality is the associated factor of comprehensiveness.Omission of risk information is the most common violation cited by the FDA in enforcementletters (page 3), and this guidance makes clear that the FDA considers that, “[t]he mostserious risks set forth in a product’s labeling are generally material to
presentation of efficacy.” (page 12, emphasis in original)
There is a “
hierarchy of risk information
” (page 9) related to any drug that FDA considerswhen determining whether a piece is in compliance with the risk presentation requirement.Which risks are presented first (and last) matters and should reflect the relative importance of the risks (e.g., organ failure comes before mild nausea).3.Relating to the presentation of risk information in video and/or audio, the following factors arecalled out:a.On-screen supers must be readable, comprehensible, and tied closely enough to benefitinformation.
On-screen text should be presented so that a reasonable reader can read andunderstand it (e.g., scrolling speed of copy or length of time on screen).c.Graphics should not detract or distract from any supers on screen.d.Audio and video should complement each other, not compete with different messages.
©2009 Digitas HealthPage 2 of 3

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