Bob Perkins, Vice President, Public Policy

	FDA held two days of meetings in November to address regulation of drug communications on the Web and with social media tools, and solicited industry comment (see also p. 9). AstraZeneca filed comments, excerpted below, during the recently closed comment period. FDA is expected to propose regulations later this year.

AstraZeneca believes that five principles should be at the core of any company engagement in social media: to be truthful and accurate; to respect the interests of patients; to protect and advance patient health; to be transparent; and to respect the views of others.… As an expert on our approved products and the conditions they address, AstraZeneca believes that we have an obligation to participate in social media and that our responsible participation is in the interests of patients, caregivers, health care providers, and the general public. Our active participation can provide information to help ensure that patients get the appropriate medicine at the right time and that it is taken in the right way. Our engagement will also provide a known, identifiable presence to answer questions and provide accurate information on our medicines and their approved usage … 

	... We recommend that FDA consider a regulatory framework that defines, distinguishes, and distinctly regulates three types of communications on the Internet and in social media. There are: 

1. Company-controlled, hosted online communications

 … placed on web sites and other online properties that are under the control of a product sponsor. Controlled sites and properties would be defined as those that the sponsor owns, operates, or where the sponsor retains editorial control. Such communications would include company-owned product information web sites, company controlled disease information sites, company sponsored and controlled content areas on third party web sites such as Facebook. For such communications, the company should be held accountable in a manner that reflects the letter and spirit of FDA’s promotional rules for advertising. 

. . . . that a product sponsor places or provides for use by web sites and other online properties that the sponsor does not control and where such communications are used in the form, manner, and context for which the sponsor provides it. Such communications include company sponsored and created advertisements or banners on third party web sites. They can also include company provided content such as videos, online tools, or articles. Where these communications include information on the uses of medicines or medical devices, the sponsor would have to ensure that the communication is appropriately balanced and includes information and links to further information on the risks of the medicine or device. The guidance should require the sponsor to provide this information to an extent and in a form that is appropriate to the size or other limitations of the site or forum. 

3. Real-time, social media participation communications

 [including] company real-time, social media interactions on web sites and online forums that are not company-controlled. Such communications typically occur in chat areas, comment areas or as an integral part of the operation of the web site (for example in pop up or pop over windows created by the web site creator). 

Such communications would be considered consistent with law and regulation where they are: 

appropriate to the context and intended audience of the site and the initial interaction that the product sponsor is participating in; 

when examined in that context, as a whole provide an accurate and balanced picture of the risks and benefits of the sponsor’s products, and; 

preserved along with its context, where feasible, for review and audit by the product sponsor and, at its discretion, by the FDA. 

… In contrast to these three types of communications, we believe that the FDA should define Independent Communications to include content that a product sponsor does not provide or post or material that was originally provided but that has been altered by others outside the control of the product sponsor. An example of such communication would be Google Sidewiki. Such communications would not trigger obligations from the product sponsor.

	In order to effectuate this framework, we urge the agency to adopt guidance that:

Clarifies for which communications the FDA will hold a product sponsor accountable. 

Provides instruction on how to apply promotional rules to space-restricted digital media.

Clarifies the treatment of social media conversations. 

Clarifies how existing requirements for reporting adverse events will be applied to realtime, social media communications. 

By Bob Perkins, Vice President, Public Policy and Promotional Affairs 

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