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Executive Summary

Healthcare is embracing the online world and social media like never before. The rampant use of the Internet to answer all medical, drug and device-related questions such as drug benefits, side effects, and even product dosage has made medical, drug and device manufacturers extensively explore the online world. However, these companies need to be extremely cautious about the healthcare information disseminated through online channels. Miscommunication can lead to grave consequences on legal, regulatory, financial and ethical grounds.

The U.S. Food and Drug Administration (FDA) has proposed guidelines about how drug and device makers should cope with challenges and pitfalls posed by social and online media. It has developed two draft guidance that offers instructions on how companies should attempt to correct product information for drug and device makers. The first draft deals with benefit and risk information presented on social media, while the second one deals with correction of misinformation by third parties such as websites run by others and chat rooms.

This eBook aims to analyze the evolution of these guidelines, their outlines and representative examples.

Overview

With social media becoming a way of life, patients and healthcare providers regularly receive information about FDA-regulated medical products through the Internet and specifically through social media. Regardless of the online communication platform, critical issues like public health are best served by clear, accurate and explicit information.

With this in mind, the FDA has proposed two draft guidance for the healthcare industry. The guidance comes with recommendations to help manufacturers and their representatives accurately present online communication about prescription drugs and medical devices. These documents address the presentation of risk and benefit information for prescription drugs and devices in view of:

• Internet/social media platforms permitting limited character usage, such as Twitter • How a firm may correct misinformation shared by an independent third party about a product approved or cleared by the FDA

Table of Contents

• Executive summary

• Overview

• Evolution of Draft Guidance

• Details of Draft Guidance

• The Way Ahead

- First Guidance - Prescription Drugs or Medical Devices Using Social Media - Second Guidance - Third Party Information

First Guidance: Prescription Drugs or Medical Devices Using Social Media with Character Limitation

Evolution of Draft Guidance

Details of Draft Guidance

The guidance documents have been released nearly five years after the FDA held a public hearing to sift through Internet issues confronting drug and device makers. They come in response to stakeholders’ requests for specific guidelines on best practices from companies and other stakeholders, which can be applied to existing Internet sites. These draft guidance documents are the latest in a series, and the Agency is keen to receive comments from stakeholders.

The draft represents FDA's evolving thoughts on social media sites and other Intenet-related matters. FDA actively reviews, analyzes and develops approaches to a variety of topics related to labeling and advertising of medical products. These include the development of these and other guidance documents addressing use of social media platforms and the Internet.

This guidance recommends the presentation of risk and benefit information for prescription drugs or medical devices using Internet/social media sources with character space limitations, such as Twitter and paid search result links on Google and Yahoo. FDA reinforces regulatory requirements and concepts applicable to product promotion, and maintains that benefit information should be balanced by presenting content- and prominence-comparable risk information.

The Agency acknowledges the challenge medical drug and device firms may face in achieving the appropriate balance while presenting product information. At the outset of campaigns, FDA advises the promoting company to evaluate whether the platform is appropriate for promotion of that product. For example, products with complex indications or extensive serious risks may not be amenable to promotion via character-limited platforms.

FDA outlines three factors in promotion via Internet/social media platforms with character space limitations:

1. General factors: In each communication, benefit information must be accurate and reveal material facts. It should be accompanied by risk information. If adequate benefit and risk information as well as other required information cannot be communicated within the character limits, FDA encourages the firm to reconsider the platform's use.

2. Risk information disclosure factors: In each communication, risk information (at the minimum, the most serious risks) should be presented with benefit information. The audience should be given direct access to a complete discussion of risk information. This might be a hyperlink routing the audience to a non-promotional landing page dedicated to risk information.

3. Other product information recommendations: Two additional requirements include presenting the promoted product's established name and including at least one specific dosage form and quantitative ingredient information. FDA indicates that a firm should include the established name directly after the brand name, but accepts the use of recognized linguistic symbols in place of words and scientific abbreviations for chemical ingredients. It suggests the latter requirement will be satisfied by including at least one dosage form and quantitative ingredient information (with the brand and established names) on the hyperlinked risk information landing page.

This draft guidance does not address promotion via product websites, webpages on social media networking platforms (individual product pages on Facebook, Twitter and YouTube) and online web banners. The FDA believes that these platforms do not impose the same character space constraints as online microblog messaging and online paid search.

Also, this guidance does not address responsive web design or other technology-specific layout features that present different product promotions depending on the technology medium (desktop computer monitors, mobile devices and tablets) used.

Tom Abrams – Head, FDA Office of Prescription Drug Promotion

“These are intended to have a beneficial impact on public health. But these were not developed in a vacuum. They were developed with careful consideration and with input from industry and many other stakeholders. There was a lot of important consideration given to the issues.”

"Half of the world's 50 largestdrug makers still do not usesocial media to engage withtheir consumers or patients."

- IMS Institute for Health Informatics

In this example, the brand and established names are communicated together within the sponsored link format.Being consistent with Google’s link requirements, the firm creates four different landing pages to convey risk information. At the top of each landing page, the firm again communicates the brand and established namestogether with the dosage form and quantitative information in direct conjunction: Headhurtz (ouchafol) 200mg tablets.FDA would not intend to object to this sponsored link format for Headhurtz.

Scenario 1

Hypothetical Examples about Representation of Risk-Benefit Information

A firm wants to promote its prescription drug NoFocus on Twitter, using the mandatory 140 characters per tweet. NoFocus is indicated for mild to moder-ate memory loss. There are no boxed or other warnings and no known fatal or life-threatening risks in the product information. The most serious precaution is that it may cause seizures in patients with a seizure disorder. The FDA approved name is NoFocus (rememberine hydrochloride) capsules, and NoFocus is available as 200 mg capsules. The firm considers including the following product information, together with benefit and risk information about NoFocus, within the tweet as shown below:

Scenario 2

In this example, the brand and established names are communicated together. The firm uses a dash with no additional spaces to separate the benefit and risk information. They also include a direct hyperlink to the Important Safety Information webpage (within the product website) devoted to providing comprehensive risk information about NoFocus.

First Guidance does not address promotion via product websites, webpages on social media networking platforms (individual product pages on Facebook, Twitter and YouTube) and online web banners.

NoFocus (rememberine HCl) for mild to moderate memory loss-May cause seizures in patients with a seizure disorder www.nofocus.com/risk [134/140]

Headhurtz (ouchafol) [20/25] www.headhurtz.com [17/35] For severe headache from traumatic brain injury [47/70]Boxed warning [13/25] Warning [7/25]Potential for brain swelling [28/35] Potentially fatal drug reaction [31/35] Warning [7/25] Risk information [16/25] Life-threatening drop in heart rate [35/35] Important safety information [28/35]

A firm wants to promote its prescription drug Headhurtz using Google’s Sitelinks. Headhurtz is indicated for severe headache associated with traumatic brain injury. The product information for Headhurtz includes a boxed warning about the potential for brain swelling, potentially fatal drug reaction and a drop in heart rate that may be life-threatening. The FDA approved name is Headhurtz (ouchafol) tablets and Headhurtz is available in 200 mg tablets.In addition to communicating benefit and risk information, the firm should also communicate the brand and established names within the sponsored link format.The firm considers including the following within the sponsored link format:

Examples about Correction of Third Party Information or Misinformation

Second Guidance: Third Party Information

This guidance provides recommendations to companies that correct third-party information about their own prescription drugs and medical devices. It provides FDA's recommendations on correction of misinformation from independent third parties on the Internet and social media. FDA recommends that any correction should address all misinformation in a clearly defined portion of a forum on the Internet or social media. This misinformation might either be positive or negative.FDA states that while "the Internet has facilitated the transmission of information, allowing patients and other interested parties the opportunity to share experiences as well as to communicate with others about drugs and devices," such information "might not always be accurate and may be dangerous or harmful to the public health." FDA differentiates between "communications that are owned, controlled, created or influenced, or affirmatively adopted or endorsed by, or on behalf of, the firm" to which the guidance does not apply.

To facilitate the correction of misinformation by third parties, the draft guidance specifies three parameters:

1. Appropriate corrective action: The firm should provide information that is relevant, tailored to the misinformation, non-promotional, accurate, consistent with the product's labeling and discloses the affiliation of the provider to the firm.

2. Extent of misinformation corrected: Although a firm is not expected to correct all misinformation in a forum, it should identify the misinformation and portion of the forum it is correcting. This is to ensure that readers do not assume the firm has responded to the entire forum.

3. Approaches to corrective action: The firm may choose among several approaches to make the correction. These include correcting information directly in the forum, providing corrective information to the author of the misinformation or requesting the author to remove the misinformation or allow comments to be posted.

This guidance provides a safe harbor for firms correcting misinformation. FDA does not expect the firm correcting misinformation to continuously monitor the forum. As long as the correction is made in accordance with the guidance, "FDA does not intend to object if these voluntary corrections do not satisfy otherwise applicable regulatory requirements, if any." Finally, FDA does not expect firms to report corrections, but they should "keep records to assist in responding to questions that may come from the Agency."

Draft guidance applicable Draft guidance not applicable

As part of a firm’s marketing campaign, one of its marketing department members posts incorrect statements about a product’s safety or efficacy, compared to a competitor’s product on a discussion board hosted by an independent third party. The firm is responsible for content of the communication, because the member is acting on behalf of the firm.

A firm hosts a discussion group on its website and monitors the discussion for content that does not speak positively about its product. It removes or edits postings that portray its product negatively, and adds positive postings. This firm is exerting control over the user generated content and is responsible for the resulting content. Thus, its actions would not fall under the scope of this guidance.

A firm becomes aware of a blogger posting inaccurate information about its products. The blogger does not have a relationship with the firm. The firm does not compensate the blogger and is not responsible for the blog content. It may decide to correct the misinformation, but is not obligated to correct it.

A firm hosts a discussion forum about its drug’s or device’s FDA-approved use on its corporate website. It does not participate, but monitors the forum for profanity and obscenity. The forum includes a clear and conspicuous statement that the firm did not create the forum content. The firm is not responsible for information posted by independent third parties, and can correct misinformation according to this guidance.

References

FDA sees social media as an important resource for the industry and is committed to developing additional guidance for drug and device manufacturers that outline the Agency's current thinking.The FDA is in the process of inviting comments during which further inputs will be gathered before finalized versions are released. FDA officials will use the guidance as trial-and-error blueprints themselves, as they run across questions not answered or situations not anticipated. With the best interests of patients in mind, FDA’s guidance documents raise some important issues that might invite comments, inputs and feedback from industry experts before they are finalized and ready to be used.

• FDA issues draft guidances for industry on social media and Internet communications about medical products: Designed with patients in mind, July 2014

• FDA Releases Draft Guidance On Internet/Social Media Product Promotion And Correction Of Misinformation, June 2014

• The U.S. Food and Drug Administration, Draft Reports, June 2014

• FDA Finally Proposes Social Media Guidelines, The Wall Street Journal, June 2014

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The Way Ahead