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Web 2.0 generally refers to the second generation of uses of the internet. It is not characterized as much by new technology, but rather by new uses of current technology and resulting new behaviors for users, i.e., sharing and collaboration tools for users as well as user-generated content. We are all familiar with blogs, wikis, FaceBook, MySpace, YouTube, and Twitter. In 2009 no company can rely solely on traditional broadcast and print media to get its message out. Industry is increasingly figuring out how to further incorporate the internet and emerging social networking media into its promotional activities, and FDA-regulated companies are no exception.
    
Web 2.0 is reality, and “it is here to stay,” said Dr. Jean Ah Kang of the Food and Drug Administration’s (FDA) Division for Drug Marketing, Advertising and Communications (DDMAC). Having recognized this, pharmaceutical, biotech and medical device companies are poised to make full use of the internet and Web 2.0 advances in the marketing and promotion of their products. However, the uncertainty surrounding FDA regulations and their applications to new media may be deterring these companies from taking full advantage of these new opportunities. In crafting their marketing and promotional plans using the internet and Web 2.0, without clear guidance, these companies are left to piece together what little advice DDMAC has offered.    

DDMAC has not issued explicit guidance on how it might adapt current regulations to the changing landscape nor on how companies can comply with regulations in regards to Web 2.0 promotion and advertising. However, three recent developments by DDMAC illustrate how the current regulations may play out in the Web 2.0 landscape. On March 17, 2009, Dr. Jean Ah Kang, Special Assistant to Tom Abrams at DDMAC in charge of Web 2.0 policy development, issued some preliminary guidance on the application of the FDA’s regulations to new media.¹ Ironically, her guidance was issued in a podcast. On March 26, 2009, the FDA issued letters to fourteen major pharmaceutical companies warning of violations to the Federal Food, Drug, and Cosmetic Act and the FDA implementing regulations arising from pharmaceutical companies’ use of internet search ads.² Finally, in May 2009, the FDA issued draft guidance for the industry titled “Presenting Risk Information in Prescription Drug and Medical Device Promotion.”³ Taken together, these three developments begin to illustrate how pharmaceutical companies may proceed in implementing and utilizing Web 2.0 advertising and promotion campaigns.   

In moving to integrate internet promotions and social media into their campaigns, pharmaceutical, biotech and medical device companies must still tread cautiously. While the FDA has not set out explicit guidelines for compliance, we can tease out some principles that will provide guidance in complying with FDA regulations. Above all, the net impression of promotional material must be accurate and not misleading. Even in the face of space constraints, promotional material must balance the presentation of efficacy information with the presentation of risk information in both prominence and content in a single view.          Beyond these principles, Dr. Kang articulated the FDA’s and DDMAC’s concern with the level of involvement by the company. If a company or someone on behalf of a company created the promotion, it will be expected to comply with the regulations. If a company or someone on behalf of a companyany part of the activity, including prompting someone else to communicate, it will be expected to comply with the regulations. But, on the other hand, a company is not responsible for what other people do with the content it posts in a public forum. However, what constitutes a company’s control of the activity may still be an open question. Several factors in determining control include – who generated the content, who (if anyone) paid for the content, and whether the company permits and monitors user-generated content.     The FDA and DDMAC will likely continue to clarify their thinking on these issues. But, in the meantime, pharmaceutical, biotech and medical device companies' use of Web 2.0 media will continue to expand. As always, companies are well advised to keep current with FDA guidance and recent warning letters in developing promotional materials and in expanding their use of social networking media.

¹Eye on FDA, A Conversation with FDA/DDMAC About Pharma, Social Media and Web 2.0, (March 17, 2009), http://www.eyeonfda.com/eye_on_fda/2009/03/a-conversation-with-fdaddmac-about-pharma-social-media-and-web-20.html

²  Food and Drug Administration, Warning Letters,  http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM055773

³Food and Drug Administration, Draft Guidance, Presenting Risk Information in Prescription Drug and Medical Device Promotion (May 2009), http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM155480.pdf

This advisory was prepared by the Life Sciences practice group at Nutter McClennen & Fish LLP. Assistance on the drafting of this advisory was provided by Nutter summer associate Erica Carroll. Please call your Nutter attorney (617-439-2000) if you have any questions or need assistance in reviewing your materials or promotional strategy.

This update is for information purposes only and should not be construed as legal advice on any specific facts or circumstances. Under the rules of the Supreme Judicial Court of Massachusetts, this material may be considered as advertising.