Out-Law News 4 min. read
24 Jan 2014, 4:03 pm
The Food and Drug Administration (FDA), which regulates the manufacture, sale and distribution of drugs in the US, has issued draft new industry guidance (10-page / 120KB PDF) on how drugs companies can comply with regulatory obligations when advertising on social media and other digital channels.
US rules require drugs companies operating in the country to submit promotional labelling and advertising pieces to the FDA at the time of initial dissemination and when adverts are published. However, the regulator said that drugs companies face a "challenge" in meeting those 'postmarketing submission requirements' where they use "interactive promotional media", especially where information is "displayed in real time".
As a result, the FDA has set out a proposed framework and timetable for drugs companies to notify them of promotional activity on social media and other online channels.
Expert in social media Jo Alderson of Pinsent Masons, the law firm behind Out-Law.com, said that US pharmaceutical companies have been "crying out for clearer guidance about their responsibilities in respect of advertising on interactive media" and that their use of social media has, to-date, been low.
The FDA said US drugs companies will be held responsible for notifying it of "product promotional communications on sites" that they either own, control, have created, have influence over, operate or are operated on their behalf. Examples of such promotional activity would be where drugs companies run an online forum on which customers can comment on their products, it said.
In addition, the FDA said US pharmaceutical manufacturers may be held responsible for promotions via third party communication channels.
"A firm is responsible for promotion on a third-party site if the firm has any control or influence on the third-party site, even if that influence is limited in scope," the FDA said. "For example, if a firm collaborates, or has editorial, preview, or review privilege, then it is responsible for its promotion on the site and, as such, that site is subject to submission to FDA to meet postmarketing submission requirements."
"However, if a firm provides only financial support (e.g through an unrestricted educational grant) and has no other control or influence on that site, then the firm is not responsible for information on a third-party site, and has no obligation to submit the content to FDA. Furthermore, if a firm is merely providing promotional materials to a third-party site but does not direct the placement of the promotion within the site and has no other control or influence on that site, the firm is responsible only for the content it places there and, thus, is responsible only for submitting to FDA promotional content that was disseminated on that site," it added.
The FDA said it would also expect drugs companies to disclose promotional activity undertaken by staff on their behalf, such as through employee blogs or if staff comment on their products on third party websites.
"FDA recommends that a firm be transparent in disclosing its involvement on a site by clearly identifying the [user generated content (UGC)] and communications of its employees or third parties acting on behalf of the firm," the draft guidance said. "This could be achieved by inclusion of the firm's identifier (e.g name or logo) as part of the communication. However, a firm generally is not responsible for UGC that is truly independent of the firm (i.e is not produced by, or on behalf of, or prompted by the firm in any particular)."
"FDA will not ordinarily view UGC on firm-owned or firm-controlled venues such as blogs, message boards, and chat rooms as promotional content on behalf of the firm as long as the user has no affiliation with the firm and the firm had no influence on the UGC," it said.
The new guidelines state that drugs companies should provide the FDA with a list of the various channels they promote products on, from their own website and social media accounts to third party sites and forums commented on by staff members.
The companies would then be generally obliged to provide an updated monthly list of the sites on which product promotions have taken place, although they would not be required to "submit screenshots or other visual representations of the actual interactive or real-time communications" with those updates.
The FDA also advised of a slightly different reporting duty for when promotional activity is hidden behind access restrictions, such as paywalls. On such occasions, the drugs companies would need to provide the FDA with access to all content associated with promotional material to "adequately provide context to facilitate the review", it said.
"The FDA guidance on the disclosure requirements, while clearer, may not be compatible with the use of all social media, for example Twitter’s 140 character limit," Jo Alderson of Pinsent Masons said. "Whether this clearer guidance will serve to encourage US pharma companies to make more use of social media or whether the substantial disclosure requirements will act as a deterrent or barrier will remain to be seen."
"In the UK, regulation prohibits advertising of prescription drugs to members of the public. This in itself impacts on whether pharma companies will choose to use the traditionally more consumer focussed social media channels for advertising," she said.
"The regulation of advertising of drugs and medical devices in the UK is a strict regime which has not yet been brought fully into line with the digital era. UK companies are encouraged to embrace social media but also to proceed with caution. In addition to the restriction on consumer marketing of prescription drugs, careful consideration should be made in relation to the channels used, the regulatory disclosure requirements and the control of employees’ use of social media on behalf of the regulated company," Alderson added.
According to a new report issued by IMS Health, a global information, services and technology company in the health sector, 23 of the world's biggest 50 pharmaceutical manufacturers use social media to engage with patients on "healthcare-related topics". It said, though, that "regulatory uncertainty remains a factor limiting social media use".