The recommendations cover the use of “blogs, microblogs, social networking sites, online communities, and live podcasts that firms use to promote their drugs.”
Under the guidance, pharmaceutical firms using social networks will be required to submit a copy of their first post to the FDA.
If the site has restricted access, such as a “closed” Facebook or LinkedIn group or a “protected” Twitter account, businesses will be asked to submit screenshots of all activity.
If the feed is unrestricted to the public, firms will not be required to provide copies of every post, but should update the FDA once a month with names of the social networks they use, and the date of their most recent activity.
Employees’ personal accounts, when used to promote a pharmaceutical product, fall under the guidance.
The policy draft covers not only online discussion forums on pharmaceutical companies’ own websites, but also corporate posts on sites they do not own or control, such as Twitter or Facebook.
Under the Federal Food, Drug, and Cosmetic Act, US pharmaceutical companies must notify the FDA of all promotional and advertising materials “at the time of initial publication of the advertisement for a drug.”
However, companies have been waiting for several years to hear how this regulation could be applied to platforms like Facebook and Twitter, where users send posts instantly and potentially dozens of times per hour.
The FDA’s document acknowledged the difficulty of submitting copies of social media activity as it happens in “real-time”, due to the enormous probable volume. It would instead “exercise enforcement discretion regarding the regulatory requirements” regarding promotion on social media, it said.
Rules on traditional, printed advertising would remain the same, said the FDA.
The Federal Food, Drug, and Cosmetic Act requires standard advertisements and “other descriptive printed matter” issued by the manufacturer to state the name, quantitative ingredients, and clear and neutral information on side effects, contraindications and effectiveness of the drug.
The FDA’s first draft guidelines on online marketing did not make clear whether social media content, with its limited space, would be exempt from this condition. Twitter restricts users’ posts, or “tweets”, to 140 characters.
Recommendations on online marketing has been expected by the pharmaceutical industry since a document was mandated by by the Food and Drug Administration Safety and Innovation Act in 2012.
The law stipulated guidance must be issued “regarding the promotion, using the Internet (including social media)” of controlled drugs “not later than 2 years” after the signing on the act, meaning the FDA must produce a finalised recommendation by July 9 2014.
The FDA has invited comments on the draft document within the next 90 days.