A Legal Guide to the Commercial Risks and Rewards ... - Reed Smith

More documents

Recommendations

Info

Network Interference: A Legal Guide to the Commercial Risks and Rewards of the Social Media Phenomenon— CHAPTER 7 —Food and Drug AdministrationChapter Authors 281Colleen T. Davies, Partner – cdavies@reedsmith.comKevin M. Madagan, Associate – kmadagan@reedsmith.comIntroductionSocial media, the now-entrenched Internet phenomenon, enables decentralized, real-time communication among small and largegroups of individuals, organizations and businesses. Social media is a fast-paced, immediately gratifying interactivecommunication venue that allows website content to evolve and be transmitted instantaneously to an audience of anonymous,active or passive observers.The ability to communicate so fluidly, however, renders social media communications reliably unpredictable and illusive, thusposing unique challenges for regulatory authorities as well as the companies they regulate, especially with regard to advertising.One of those regulatory authorities, the Food and Drug Administration (“FDA”), has jurisdiction over companies involved with themanufacturing of medical products, such as drugs, biologics, medical devices, and emerging biotechnology products.This chapter explains why even though various business sectors have fervently embraced social media as a product marketingtool, the FDA-regulated industry has been slow to adopt this practice. It also explores FDA’s emerging policy on Internetmarketing activities, and specifically the potential risks associated with using social media to disseminate promotional messagesand scientific information about FDA-regulated prescription drugs and devices. It then provides suggestions on how to proceednow, before FDA issues a guidance document on social media and product promotion.Social Media in Action in FDA-RegulatedIndustryEverybody’s Talking But the ExpertsConversations through online social media communitiesamong health care professionals, consumers, and others,about FDA-regulated prescription products and diseasestateshave been taking place for some time. Sermo, forexample, one of the largest online physician socialnetworks spanning 68 specialties in 50 states, waslaunched in 2006 and now provides a venue for more than112,000 physicians to exchange observations in real-timeabout drugs, devices and clinical issues. Consumers areequally active. More than 60 million consumers used socialmedia to communicate and research health and medicalinformation in 2008. 282What is lacking in many of these social mediacommunications, however, is an authoritative source ofinformation about prescription products and the conditionsand diseases for which they are used. As experts on theirproducts, many companies want to serve in this capacity.They want to use social media to disseminate informationabout their products to ensure that accurate, transparent,high-quality information is being communicated to socialmedia participants. Many feel this could be one of the bestways to reach target audiences effectively.But companies are concerned about the not-insignificantconsequences of improper marketing, which can vary, butwhich may include the cost of remedial advertising,damage to reputation, and civil fines. 283 The government,for example, has collected billions of dollars in fines,forfeitures, and disgorgements from drug companies overtheir practice of marketing products for unapproved, or “offlabel,”uses. 284 In the worst case, violating the Food, Drug,and Cosmetic Act (“FDCA”) may be considered a strictFood and Drug Administration 57
Network Interference: A Legal Guide to the Commercial Risks and Rewards of the Social Media Phenomenonliability misdemeanor, which becomes a felony when thereis intent to defraud or mislead. 285Not surprisingly, then, without some guidance from FDA,companies are not using social media to market theirprescription products. Prescription product marketing hasbeen restricted to more controlled, non-interactivestrategies using conventional Internet outlets, such as fixedwebsites, and links to and from websites—which, bytoday’s standards, are antiquated avenues for advertising.To be fair, companies are not avoiding social mediaentirely; many have a social media presence throughcompany blogs, Facebook pages, YouTube channels,LinkedIn profiles, and Twitter accounts. But the informationdisseminated through these venues is mostly limited toinformation about corporate developments and healthconditions or diseases. To the extent that these venues arebeing used to disseminate information about prescriptionproducts, such as a YouTube video, for example, the veryfeatures that make the media “social” have been disabled(e.g., the ability to post comments under a YouTube video).Current Legal and Regulatory FrameworkFDA’s Emerging Social Media PolicyFDA’s rules were written long, long before the Internet waseven a word. They contemplate large, cohesive swaths ofinformation, uninterrupted by others’ comments, reactions,or discussion, and require careful attention to ensure thatpromotional messages are truthful, non-misleading, andfairly balanced between the benefits and risks associatedwith a particular product. 286 When these regulations areapplied to any activity on the Internet, determining what ispromotional and how to apply the regulations can bechallenging. FDA held public hearings on Internetadvertising and promotion in 1996, 287 but then failed toissue any guidelines and subsequently halted all suchwork, presumably because the agency was not ready orprepared, or even knew how to act. In 1999, FDA furtherdelayed taking a position by informing the industry that itwould “look at [Internet] issues on a case-by-case basis,”while reserving the right to revaluate the need forregulations in the future. 288 As a result, in order to gleanFDA’s Internet and social media policy, the industry hasbeen forced to scrutinize individual enforcement actionsagainst companies that have created and used Internetwebsites for improper promotion of their products. 289Yet, in many ways, these enforcement actions have beensimilar to more traditional advertising actions in that thewebsite owner had control of the content, its display, andaccess to it. In 2008, for example, FDA issueda Warning Letter concerning a YouTube videoadvertisement, but the fact that the video was posted onYouTube was irrelevant; the Warning Letter would havebeen the same had the video been broadcast in apromotional conference hall.There are some exceptions, however, including few actionsthat highlight challenges particular to the Internet, such asdetermining when a link from page-to-page or fromwebsite-to-website is a continuation of the advertisementand, thus, also subject to the many regulatory contentrequirements and restrictions. For instance, over the pastfew years, the industry had developed a theory commonlyreferred to as the “one-click” rule under which FDA’srequirement to provide comprehensive product information,including safety information, in promotional material can besatisfied if such information is directly accessible from alink in the original promotional piece (i.e., no more than oneclick away). This rule was placed into question when FDAissued enforcement letters last year to 14 companies fortheir failure to include risk information in Google banneradvertisements. 290 These letters first revealed FDA’s newthinking on the matter, and sent shock waves throughoutthe industry, causing many companies to reassess theirInternet marketing strategies. FDA has subsequently statedthat it “never had what some are referring to as a ‘one-clickrule.’” 291Recent DevelopmentsLike a giant awakening from a 100-year nap, FDA recentlyacknowledged the special nature of the Internet as amarketing tool and venue, and has renewed its interest inaddressing Internet communications. FDA held a publichearing in November 2009 and solicited written commentsthrough a public docket that was open from September2009 to February 2010. These actions are intended to helpFDA determine how the statutory provisions, regulations,and policies concerning advertising and promotionallabeling should be applied to product-related information onthe Internet and newer technologies. 292 Recently, FDAmade the following statement about social media andcompliance:We believe it is a good idea for companies to have arobust policy in place for any type of promotion abouttheir products, including social media promotion. Wewould advise them to carefully review their materialsand processes to ensure that their promotion iscompliant with the regulations. Consumers andhealthcare professionals deserve an accurate andFood and Drug Administration 58
Page 1 and 2:
(Second Edition)- 1 -US_ADMIN-78068
Page 3 and 4:
Network Interference: A Legal Guide
Page 5:
Page 8 and 9:
Page 10 and 11: Network Interference: A Legal Guide
Page 110 and 111:
Page 112 and 113:
Page 114 and 115:
Page 116 and 117:
Page 118 and 119:
Page 120 and 121:
Page 122 and 123:
Page 124 and 125:
Page 126 and 127:
Page 128 and 129:
Page 130 and 131:
Page 132 and 133:
Page 134:
show all

A Legal Guide to the Commercial Risks and Rewards ... - Reed Smith

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?