FDA forms a view on pharma use of social media


The FDA, still to produce a final set of rules, has drafted some guidance on the postmarketing use of "interactive media" by pharma companies, giving examples of what it would consider to be within the control of regulated firms - and the use of social media by employees is one of the examples cited in the report.

The FDA says pharma companies would be responsible if, for example, employees used the internet to make comments about a drug.

The comments, and the site where they are left, would not need to be under the direct control of the drugs company. The guidance extends to use of sites such as Facebook, Twitter and blogging sites.

"FDA's regulation of prescription drug product promotion extends both to promotional activities that are carried out by the firm itself, and to promotion conducted on the firm's behalf.

"Therefore, a firm is responsible for the content generated by its employees or any agents acting on behalf of the firm who promote the firm's product.

"For example, if an employee or agent of a firm, such as a medical science liaison or paid speaker (e.g., a key opinion leader) acting on the firm's behalf, comments on a third-party site about the firm's product, the firm is responsible for the content its employee or agent provides.

"A firm is also responsible for the content on a blogger's site if the blogger is acting on behalf of the firm."

US Food and Drug Administration, draft guidance.



Related news:

FDA marketing regulations include pharma employees' Facebook (In-Pharma Technologist).

FDA hands pharma marketers another piece of social-media guidance (FiercePharma).

Reference link:

Guidance for industry fulfilling regulatory requirements for postmarketing submissions of interactive promotional media for prescription human and animal drugs and biologics: draft guidance (FDA).


15 January, 2014