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The FDA Opens the Floor for Change

This past week I had the pleasure of attending the 2 day FDA hearing on the use of the Internet and social media for the marketing of pharmaceuticals. The purpose of the hearing was to open discussions about updating the current guidelines set forth by the FDA.The hearing format was interesting. Speakers, which included agencies, drug companies, public advocacy groups, site publishers and private citizens, addressed the FDA panel to provide feedback to 5 specified topics: What parameters or criteria should be applied to determine when third-party communications occurring on the Internet and through social media technologies are subject to substantive influence by companies that market products related to the communication or discussion? In particular, when should third-party discussions be treated as being performed by, or on behalf of, the companies that market the product, as opposed to being performed independent of the influence of the companies marketing the products? How should companies disclose their involvement or influence over discussions or material, particularly discussions or material on third-party sites? Are there different considerations that should be weighed depending on the specific social media platform that is used or based on the intended audience? If so, what are these considerations? With regard to the potential for company communications to be altered by third parties, what is the experience to date with respect to the unauthorized dissemination of modified product information (originally created by a company) by noncompany users of the Internet?Many of the agencies and drug companies shared their findings from private and funded research. There were several consistent themes that emerged from these studies: The Internet is a growing and significant source of information for people researching health information. The current lack of clear direction from the FDA is keeping legitimate pharma companies on the sidelines of getting involved with social media and many forms of online advertising. This leaves a void that is frequently being filled by less desirable and often illegal advertisers. Consumers and medical professionals want drug companies to participate in an open, non-promotional way to share their knowledge and research in the discussions that are happening across social media channels. While not as prevalent, some of the most interesting discussions where those that questioned the efficacy of the FDA guidelines in general. It would seem that in many cases, the issues of including fair balance between risk/benefit and access to prescribing information in marketing materials, as mandated by the FDA, is not what is putting consumers at risk. The problem is that this 'required' information often exceeds the level of comprehension for most consumers. So including a link to important safety information from a Tweet or search ad may satisfy the requirements of the FDA, but it is completely failing the objective of the FDA, which is to protect the public health. Likely the result of years of lawyering and policy making, the FDA approved language that makes up the small print in magazine and online ads and quick speak at the end of TV commercials has warped into something that exceeds the health literacy of the general public. The language needs to be simplified in order to be effective and the FDA needs to create a standard for displaying important safety information across health sites to aid in consumer recognition and accessibility. These changes would not require the FDA to introduce new policy to address the challenges posed by the Internet and social media. The current policies are sufficiently obtuse and can be morphed to apply to new media. Instead, the FDA needs to work with drug companies to provide the guidance necessary for acceptable participation across social media. Without this, we will continue to see an onslaught of unregulated online pharmacies and snake oil salesman, a situation that is both confusing and hazardous for the general public. Without clear guidance from the FDA, legitimate drug companies will be forced to sit on their hands for fear of overstepping the murky lines of compliance and the wealth of information that they possess will remain unavailable to consumers.

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