Companies that make or market FDA-regulated products are increasingly using Internet and social media tools such as Google searches, Twitter, Facebook and Wikipedia to promote their products and to provide other important information to consumers and health care professionals. While the Internet and social media provide significant benefits to consumers, industry, healthcare professionals and the public as a whole, these forms of media present new legal and regulatory challenges with respect to promotional labeling and advertising, third-party communications about a company’s products, and potential adverse events identified in blogs, chat rooms, and other forms of social media.
On November 12-13, 2009, FDA held a public hearing on the promotion of FDA-regulated medical products using the Internet and social media tools to hear from industry leaders, consumers, public interest groups, and media professionals. The hearing followed a panel-style format in which pre-selected speakers gave prepared remarks with accompanying slide presentations. FDA panel members asked questions of the speakers, but did not otherwise provide prepared remarks or invite participation from the audience.
Internet companies and regulated industry representatives discussed the need to differentiate Internet and social media from other forms of labeling or advertising because, unlike traditional promotional labeling and print or broadcast advertisements, Internet and social media users have a greater ability to control, alter and respond to the promotional messages and other product information they receive. Speakers such as Eli Lilly, sanofi-aventis, and Pharmaceutical Research and Manufacturers of America (PhRMA) agreed that manufacturers should be accountable for online content they control, but noted that manufacturers should not have a broad obligation to police or remove all forms of third-party content about their products.
The prevailing view was that manufacturers should be responsible for any content located on company sites, third-party sites on which they have a company page (e.g., Facebook), and information on any other third-party sites sponsored by the manufacturer or over which the manufacturer exerts any influence or control, financial or otherwise. On the other hand, manufacturers should not be responsible for content on independent third-party sites over which the manufacturer has no influence or control.
Speakers also acknowledged that, given the amount of information available on the Internet, it is important to be able to identify reputable information. PhRMA, among others, suggested use of an FDA-approved logo or seal of approval that could be affixed to a sponsored link, web page, or particular information on a web page, indicating that FDA had reviewed and approved that information.
Consumer and non-profit groups expressed contrasting views from those of industry and on-line marketing agencies. For instance, Consumers Union noted that pharmaceutical companies should not be engaged in promotion through blast emails or chat rooms, and that the regulations that exist for monitoring promotion through traditional media should also apply on-line, and perhaps even more stringently. Its representative stated that the limited space provided in blog or chat room formats is not a valid reason to not comply with the relevant regulations. He also stated that search engine use should be reviewed by FDA.
With respect to issues related to postmarketing reporting of adverse events (AEs), speakers acknowledged uniformly that the Internet presents a range of difficulties. Numerous speakers stated that drug manufacturers are hesitant to fully engage in online social media specifically because they want to avoid learning about potential AEs and the resulting reporting obligations, particularly because the guidance in this area is unclear. Several speakers recommended that FDA shift its focus on AE reporting from manufacturers to patients or consumers, who are currently able to report AE information on the FDA website. Speakers noted, however, that the current reporting form for patients and consumers is very technical and not user-friendly, and recommended that FDA revise the reporting form for patients and consumers.
Thomas Abrams, Director of FDA’s Division of Drug Marketing, Advertising, and Communication, concluded the two-day hearing by noting that FDA has much work to do on the issue of Internet and social networking.
Pending further guidance, companies should prepare for further FDA scrutiny of this area by developing compliance policies to address the challenges of involvement in Internet and social media tools, including but not limited to:
- Policies relating to employee involvement in social media, and in particular statements regarding company products;
- Company involvement in physician and patient-focused social media, including both company-sponsored sites and third-party sites run by third-party organizations (and particularly those receiving manufacturer support through grants or other funding);
- Addressing the challenge of Google SideWiki and similar functions that make third-party generated information directly available in conjunction with company websites;
- Updating promotional review policies to ensure consistency with developing FDA approaches to risk communication on the Internet, including sponsored links;
- Policies regarding statements that company-affiliated parties (e.g., investigators, patients) may make on the Internet, which may constitute endorsements or testimonials requiring both review and specific disclosures; and
- Ensuring a consistent and compliant approach to pharmacovigilance with respect to Internet-reported adverse events.
The archived webcast of the hearing can be found here.
UPDATE: A more in-depth write-up of this issue can be found here.
- Daniel Kracov, Vernessa Pollard, Joshua Glasser, and Jennifer Newberger
