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eHealth news

27 February 2014

In January 2014 the US food and drug administration (FDA) issued their proposed guidance on how manufacturers, packaging and distributors of drugs can comply with US law when using "interactive promotional media".

In the last two years there has been a significant growth in the promotion of drugs via the internet and social media and the FDA phrase "interactive promotional media" is a reference to blogs, micro-blogs, social networking sites, online communities and live podcasts.

The FDA draft guidance is intended to assist responsible manufacturers, packers or distributors of drugs comply with the law in relation to post marketing submission requirements for interactive promotional media.

For example the draft guidance says:

"a firm provides on its product website an online forum that gives users the opportunity to post comments about the use of its product. In this case, the firm is responsible for submitting to FDA the product website to meet the post marketing submission requirements because the firm created, owns, or operates the website".

Other examples given are in relation to the promotion of a firm's drugs on a third party site as well as the comments of a firm's agents or employees on social media about the firm's products.

Comments can be submitted to the FDA within 90 days of publication thus giving a deadline of April 2014.

This article was written by Robert Bond.

For more information contact Robert on +44 (0)20 7427 6660 or robert.bond@crsblaw.com