United States: FDA Compliance And Social Media - Data Smog, Digital Strangers And FDA’s Road Not Taken

Last Updated: April 18 2012
Article by Michael A. Walsh

The Internet revolutionized how we obtain information, and social media has revolutionized how we share it. Yet the current regulatory landscape created by the Food and Drug Administration (FDA) for medical product manufacturers is comprised of rules designed for old media, wherein a medical product manufacturer's on-line speech and active participation in the dissemination of truthful product information creates an enormous risk of civil and criminal prosecution. The lack of clear regulatory guidance constrains manufacturers from providing meaningful and reliable product information.

For medical product manufacturers, three questions arise concerning their use of the Internet and social media: (1) what can they say?; (2) what are they responsible for (i.e., third-party content and adverse event reporting)?; and (3) what are the consequences of not participating?

In 2009, approximately 158 million users looked online for health information, and 50 million people used the Internet as their first source for health care information.  (Click here to view the original research findings.) In the last quarter of 2007 alone, there were "4.6 billion health-related searches across all search engines in the U.S." (Click here to view the presentation written by Google's Health division.) As patients are increasingly managing their healthcare online, social media are quickly surpassing television and print media as the primary source of health-related information.

Overwhelmingly, consumer health-related searches are driven by medical events, with users looking for a "truth-risk value proposition," and "personal experience" where two-thirds of them say online information has improved the physician-patient dialogue. Id. at 418 (statements of Larry Mickelberg). Patients are not the only ones managing health information online. According to survey data, 90 percent of physicians are online, and 75 percent are online daily. Physicians no longer simply rely on professional society meetings, journals, sales representatives, and interactions with colleagues in hospital hallways to gain information. Now, this exchange of information is being conducted on a grand scale online.

Consumers and healthcare professionals are not changing how they think because of social media – rather, social media is adapting to work the way people think. Health-related communities are forming and evolving, making interactions more productive, informative, and immediate.
In 1996, FDA held hearings to address the then newly-forming Internet, which was capable of delivering health information without the time limitations of TV or the space limitations of print media. Since 1996, the Internet has become the primary choice of both consumers and health care professionals seeking health and medical product information.

Thirteen years later, in November 2009, FDA held additional hearings regarding the use of the Internet and social media by manufacturers of FDA-regulated products. In connection with those hearings, FDA stated that "[p]olicy and guidance development for promotion of FDA-regulated medical products using the Internet and social media tools are among our highest priorities." Among the date presented to FDA at those hearings included:

  • Manufacturers should correct third-party content survey data reflected that 59 percent of the public agree
    • "companies are big enough and have enough money to make sure the Internet is accurate."
    • "End the culture of fear" – reverse the "see no evil hear no evil" approach to avoiding Federal enforcement

Since that time, and despite being "among [FDA's] highest priorities," FDA has done little to update the regulatory landscape to (1) allow manufacturers to disseminate truthful health-related information regarding its products or (2) provide guidance on what, if anything, a manufacturer must do to monitor third-party information concerning its products.

In December 2011, FDA issued its draft Guidance on Unsolicited Requests, which addressed new media but provided minimal guidance in this regard. Also in December 2011, FDA posted two notices: (1) Examination of On-Line Direct-to-Consumer Drug Promotion, which is an effort designed to conduct a series of studies to determine how best to present risk and benefit information on branded drug websites; and (2) Communications and Activities Related to Off-Label Uses of Marketed Products and Use of Products not Yet Legally Marketed (i.e., Scientific Exchange). While these current initiatives may bear on the use of the Internet and social media by manufacturers of FDA-regulated products, it is uncertain when, or if, FDA will take meaningful action. Because FDA cannot regulate the online communications or content of the consuming public or healthcare professionals, "the vacuum created by the absence of manufacturer activity within the social media ecosystem has been quickly filled by...user-generated [content]." FDA is fidgeting on the sidelines, confounded by how to fashion new rules to allow its most potent participant, the manufacturer, to participate meaningfully.

This regulatory void hinders the most potent source of reliable health information specific to medical products, both for consumers and healthcare professionals.

Industry should be an active participant in any dialogue concerning its products. But fear of FDA's criminal and civil enforcement and penalties has led the industry to take the FDA's threats seriously and manufacturers anxiously sit as bystanders. Rather than permitting industry to step in, (no matter how imperfectly), to inject truthful, reliable, scientific information, the regulations instead restrict participation and punish missteps. (See, for example, the 14 Notices of Violation issued by FDA on April 2, 2009 claiming "misbranding" (a crime under the FDCA) where risk information was a scroll or click away.

While FDA's concern for "fair balance" in presenting risk and benefit information may intuitively seem to promote the public health, a recent study surveyed 20 years of literature on the impact of FDA risk communications on health care utilization that suggests that injecting too much risk data can be as harmful as providing no risk data at all:

"[U]nintended consequences from regulatory warnings...demonstrate[] the challenge that [FDA] face[s] to design risk messages...that don't become risks themselves." Dusetzina SB, et al. Impact of FDA Drug Risk Communications on Health Care Utilization and Health Behaviors: A Systematic Review, Med Care, Jan. 18, 2012.

While consumers expect manufacturers to not only know what is being said about their products online but also to provide useful information, consumers are unaware that manufacturers are constrained from meaningfully participating in the online dialogue. The absence of reliable product information results in the public trusting "digital strangers" to provide important health care information and further fosters the public's distrust of manufacturers.

As FDA ponders its options, the Internet has morphed into a platform for personal interaction regarding health care issues on a global scale. With no new guidance from FDA in sight, industry is left with rules designed for old world media that restrict and severely punish "incorrect" participation, where both the public and manufacturers must read tea leaves when navigating their way through online health information.

Because the electronic communication frontier cannot be contained, FDA will eventually pave the way and establish rules to allow those who know the most about their health care products to provide truthful, reliable information to those who have a real and immediate need for it. The scope and tools for social media are changing more quickly than FDA can act, and the resulting absence of manufacturer presence in social media may represent a lost opportunity to an entire generation of Americans for advancement in providing important health information.

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
Michael A. Walsh
 
In association with
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Register for Access and our Free Biweekly Alert
Email Address
Company Name
Password
Confirm Password
Mondaq Topics -- Select your Interests
Accounting and Audit
Anti-trust/Competition Law
Consumer Protection
Corporate/Commercial Law
Criminal Law
Employment and HR
Energy and Natural Resources
Environment
Family and Matrimonial
Finance and Banking
Food, Drugs, Healthcare, Life Sciences
Government, Public Sector
Immigration
Insolvency/Bankruptcy, Re-structuring
Insurance
Intellectual Property
International Law
Litigation, Mediation & Arbitration
Media, Telecoms, IT, Entertainment
Privacy
Real Estate and Construction
Strategy
Tax
Transport
Wealth Management
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
United States
Worldwide Updates

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.

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 by clicking here .

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.

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.