One Click Is Enough: Satisfying FDA's Fair Balance in the Highly-Regulated Marketplace

By Gray, Randy | Rutgers Computer & Technology Law Journal, Spring 2013 | Go to article overview

One Click Is Enough: Satisfying FDA's Fair Balance in the Highly-Regulated Marketplace


Gray, Randy, Rutgers Computer & Technology Law Journal


I.   INTRODUCTION
II.  BACKGROUND & DISCUSSION
        A. FOOD AND DRUG ADMINISTRATION REGULATION
           EXPLAINED
        B. THE ONE-CLICK RULE AND THE ADVENT OF
           WARNING LETTERS
        C. GENESIS OF THE ONE-CLICK RULE
        D. WARNING LETTERS
        E. FRA's PUBLIC MEETINGS REGARDING INTERNET
           ADVERTISING
        F. FDA GUIDANCE ON THE PRESENTATION OF RISK
           INFORMATION IN DIRECT-TO-CUSTOMER
           ADVERTISING
        G. FDA's FIRST SOCIAL MEDIA GUIDANCE
III. OTHER HIGHLY-REGULATED INDUSTRY MODELS
        A. FINANCIAL SERVICES
        B. INSURANCE
        C. COMMUNICATIONS
CONCLUSION

"Our social [media] tools are not an improvement to modern society; they are a challenge to it." (1)

I. INTRODUCTION

As famously stated in Mark Zuckerberg's 2008 F8 Conference keynote address, and posted on every press release since, "Facebook's mission is to give people the power to share and make the world more open and connected." (2) It is primarily this interconnectedness and sharing mentality that has taken over the United States and the world. Facebook boasts that over one billion people actively use its social network. (3) Twitter reports 100 million active users. (4) LinkedIn touts 187 million active users, (5) And upstart location-based check-in social network Foursquare announced 25 million active users. (6) The implication of all of this: social media is here to stay.

Social media has lasting power not only due to the numbers of large players and upstarts, but also because it has permeated our society and the way we interact with each other. (7) Social communication is part of almost every modern industry, from financial services with Bank of America's "Small Business Community," (8) to telecommunications customer service with "@ComcastCares," (9) to medical services with the advent of a private social network for physicians like Sermo. (10) Companies have rushed into social media to communicate better with consumers. (11) Consumers not only expect companies to operate in social spaces, (12) but according to The Center for Client Retention survey, consumers look more favorably upon those who provide information and respond to social media-based inquiries. (13)

This Note will first lay out the history of social media in the highly-regulated pharmaceutical and medical device manufacturing industry. This Note will describe the background of the Food and Drug Administration's (FDA) promised action regarding guidance or regulations associated with social media. This Note will also describe the backlash the industry has received from the FDA by way of stern warning letters requiring strict adherence to outdated regulations rather than innovative use of Internet-based technologies to apprise consumers of the adverse effects of pharmaceutical products. This Note will further describe the FDA's statutory remit, how they have carried it out to date, and will evaluate how other highly-regulated industries regulate social media in terms of information presentation and use of links. Throughout the entirety of this Note, the author will argue that the industry-initiated "One-Click Rule" should be enough to satisfy the FDA's specific statutory fair-balance advertising requirement. Further, this Note will distinguish the Internet from traditional advertising mediums, and advocate for the promulgation of an evolved regulatory scheme as opposed to guidance documents due to the unique character of the Internet.

II. BACKGROUND & DISCUSSION

Companies in highly-regulated industries have had a particularly difficult time engaging in social media from a legal and compliance perspective. (14) Highly-regulated companies have been more resistant than others to engage in social media as a result of the potential for noncompliance with existing laws and regulations. (15) Some industry regulatory bodies, like the Financial Industry Regulatory Authority (FINRA), have provided guidance to help the industry engage with consumers. …

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