United States: FDA Releases Draft Guidance On Internet/Social Media Product Promotion And Correction Of Misinformation

Last Updated: June 23 2014
Article by Colleen Heisey

On June 18, the U.S. Food and Drug Administration ("FDA" or the "Agency") issued draft guidance documents addressing the presentation of risk and benefit information for prescription drugs and devices on internet/social media platforms permitting limited character usage, such as Twitter, and regarding how a firm may correct misinformation disseminated by an independent third party concerning a product approved or cleared by FDA. The highly anticipated draft guidance documents come in response to stakeholder requests for specific guidelines.

Guidance for Industry: Internet/Social Media Platforms with Character Space Limitations—Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices

FDA initiates its discussion of character-limited product promotion by reinforcing regulatory requirements and concepts broadly applicable to product promotion and by maintaining the standard that benefit information should be balanced by the presentation of content- and prominence-comparable risk information. The Agency, however, acknowledges the challenge firms may have in achieving the appropriate balance while also presenting necessary product information. Therefore, at the outset of any such campaign, FDA advises the promoting company to undertake the fundamental evaluation of whether the platform is appropriate for promotion of the particular product. For example, products with complex indications or extensive serious risks may not be amenable to promotion via character-limited platforms.

FDA outlines three components for inclusion in promotion via internet/social media platforms with character space limitations, namely: general factors, risk information disclosure factors, and other product information recommendations.

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

Risk Information Disclosure Factors. In each communication, risk information should be presented in conjunction with benefit information, at a minimum disclose the most serious risks for the product, and be presented with comparable prominence to benefit information. Additionally, direct access to a more complete discussion of risk information should be provided to the audience, e.g., a hyperlink routing the audience to a nonpromotional landing page dedicated solely to risk information.

Other Product Information Recommendations. Two additional requirements to be met within the character limitations include the presentation of the promoted product's established name and inclusion of 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 commonly recognized linguistic symbols in place of words and the use of scientific abbreviations for chemical ingredients to reduce character usage. FDA suggests the latter requirement will be satisfied by inclusion of at least one dosage form and quantitative ingredient information (in conjunction with the brand and established names) on the hyperlinked risk information landing page.

The draft guidance document makes effective use of examples in detailing particular promotion through Twitter and Sitelink extensions of hypothetical drugs. If the prescribed guidelines are followed, the Agency asserts it does not intend to object to promotion via these and similarly character-constrained platforms.

FDA explicitly provides that the draft guidance document is not intended to address product promotion through websites, webpages on social media platforms, online web banners, or responsive web design, maintaining these platforms do not impose the same character constraints as those contemplated by the draft guidance document.

Guidance for Industry: Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices

FDA initiates its discussion of dissemination of misinformation by summarizing the problem facing stakeholders. It 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 makes a point to differentiate "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 for how a firm may voluntarily correct the misinformation "in a truthful and non-misleading manner."

Appropriate Corrective Action. The firm should provide information that is relevant, tailored to the misinformation, nonpromotional, accurate, consistent with the product's labeling, and discloses the affiliation of the provider to the firm.

Extent of Misinformation Corrected. Although a firm is not expected to correct all misinformation in a particular forum, the firm should clearly identify the misinformation and the portion of the forum it is correcting, to ensure that readers do not assume the firm has necessarily responded to the entire forum.

Approaches to Corrective Action. The firm may choose among several approaches to making the correction, including correcting information directly on 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.

Ultimately, the draft guidance provides a safe harbor of sorts for firms correcting misinformation. First, FDA does not expect the firm seeking to correct misinformation to continue to monitor the forum that contained misinformation. Second, 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."

FDA is accepting comments on both draft guidance documents. Comments are due by September 16.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Authors
Colleen Heisey
 
In association with
Related Video
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
 
Email Address
Company Name
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
United States
Worldwide Updates
Registration
Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:
  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.
  • Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.
    If you do not want us to provide your name and email address you may opt out by clicking here
    If you do not wish to receive any future announcements of products and services offered by Mondaq you may opt out by clicking here

    Terms & Conditions and Privacy Statement

    Mondaq.com (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

    Use of www.mondaq.com

    You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these terms & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about Mondaq.com’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.

    Disclaimer

    Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use or performance of information available from this server.

    The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.

    Registration

    Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

    • To allow you to personalize the Mondaq websites you are visiting.
    • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
    • To produce demographic feedback for our information providers who provide information free for your use.

    Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

    Information Collection and Use

    We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

    We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to unsubscribe@mondaq.com with “no disclosure” in the subject heading

    Mondaq News Alerts

    In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.

    Cookies

    A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

    Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

    Log Files

    We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.

    Links

    This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

    Surveys & Contests

    From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.

    Mail-A-Friend

    If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.

    Emails

    From time to time Mondaq may send you emails promoting Mondaq services including new services. You may opt out of receiving such emails by clicking below.

    *** If you do not wish to receive any future announcements of services offered by Mondaq you may opt out by clicking here .

    Security

    This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to webmaster@mondaq.com.

    Correcting/Updating Personal Information

    If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to EditorialAdvisor@mondaq.com.

    Notification of Changes

    If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

    How to contact Mondaq

    You can contact us with comments or queries at enquiries@mondaq.com.

    If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at problems@mondaq.com and we will use commercially reasonable efforts to determine and correct the problem promptly.

    By clicking Register you state you have read and agree to our Terms and Conditions