Drawing the web tighter

Q&A connects dots between FDA and social media

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2011 promises more activity in the social media arena in numerous areas. Currently, the U.S. Food and Drug Administration (FDA) holds pharmaceutical companies liable for false or misleading third-party statements and testimonials, but the regulatory agency has now specified that this guidance can apply to comments on Facebook and other social media sites. From recent court and regulatory rulings and hearings, it is becoming apparent that adverse event reporting obligations apply to social media as well. 

The FDA regards social media as an advertising tool for the pharma industry, which means that any company that doesn't have a social media policy in place, or has a policy deemed insufficient, puts itself (and the public) at potential risk.

Attorney Anand Agneshwar is a litigation partner in the New York office of the law firm Arnold & Porter. He heads the pharmaceutical subgroup of the firm's product liability practice group and also advises clients regulated by the FDA on compliance and litigation risks.

ddn recently posed a few questions to Agneshwar on the topic of pharma regulation and the evolving world of social media.

ddn: Describe the current situation with the regulation of pharma ads on the Internet.
Agneshwar: When a pharmaceutical company advertises or makes claims about a product on the Internet, the ad must comport with FDA labeling and advertising requirements. Plaintiffs' lawyers also rely on advertisements in product liability and consumer fraud suits against companies.

ddn: Is there a difference with social media?
Agneshwar: Candidly, yes and no.

ddn: Why or why not?
Agneshwar: Well, the FDA will look at the message the company gives consumers just as it looks at product advertisements in more traditional media. So in that sense, there is no difference. Social media is different, however, because it is interactive and spontaneous, raising questions as to when and whether companies should respond to information posted by others about their products, and when information posted by others can be attributed to the company.

ddn: Can you give some specific examples of something you have seen that causes concern?
Agneshwar: Chat rooms that contain user-generated content. What statements are and are not endorsed by the company can get very blurry.

ddn: What is your view of what consumer groups are saying about this issue?
Agneshwar: Consumer groups have always focused on direct-to-consumer advertising. They look at whether pharmaceutical companies are utilizing social media to directly target consumers.

ddn: Describe the adverse event reporting rulings and how they came about.
Agneshwar: Companies must report to FDA adverse events (AEs) that they become aware of regarding their products. The International Conference on Harmonization issued a Draft Guidance in 2003 which stated that "[companies] should regularly screen their websites for potential [Adverse Drug Reaction] information." The FDA likely will take the same position towards social media.

ddn: What do you see as happening next with that area? How long will action take?
Agneshwar: The FDA likely will address adverse event reporting in the social media guidance it will shortly issue.

ddn: You said that FDA regards social media as a form of advertising. Where is this dictated?
Agneshwar: The FDA's forthcoming social media guidance will likely address this directly. The FDA historically looks at everything a company says to the public about its products—regardless of the forum—to make sure it complies with its requirements. For example, in 2009, the FDA issued 14 warning letters to various pharmaceutical companies that had product-related information—but not risk information—in sponsored links. It is easy to see that the FDA extending this scrutiny to social media sites.

ddn: What are the possible penalties to pharmas who violate the FDA rules?
Agneshwar: The most likely scenario is a warning letter demanding corrective action. The FDA may also impose civil monetary penalties, withdraw approval or seize products.

ddn: How urgent is it that companies institute social media policies?
Agneshwar: In this rapidly evolving area, it's fairly urgent. Company professionals may be active on LinkedIn, employees may discuss company products—or their managers—on blogs, and whistleblowers undoubtedly will look to the Internet. Companies must have carefully thought-through policies to manage these and other eventualities.

ddn: What's the best way to do this—through a lawyer or the company's public relations function, or can companies look at best practices somewhere else and adopt one of those? Should human resources be involved?
Agneshwar: I've seen it effectively done in a number of ways. For example, one group can be given oversight, or a multi-departmental group can be set up. In all events, a social media policy should reflect the input of human resources, as well as regulatory, litigation and intellectual property counsel.

ddn: What are the important items that should be included in a sound social media policy?
Agneshwar: Among others: transparency; clear rules on who can speak for the company, when, and about what; AE reporting; personal use, intellectual property and privacy guidelines; and maintaining confidentiality of proprietary information.

ddn: Please describe your area of expertise—anyone these days can claim they are a "social media expert"—what sets you apart?
Agneshwar: It's hard to call yourself an expert when an area is so quickly evolving. I am a pharmaceutical product liability litigator, which requires knowing both the regulatory and litigation landscape and risks. Social media has been used for some time by both plaintiffs and defendants in litigation to investigate the parties and to find embarrassing quotes and candid moments. These same concerns apply to the regulatory sphere. At Arnold & Porter, we have a multi-disciplinary group that works together to advise companies on minimizing risks associated with social media while capitalizing on the opportunities this new area promises.

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