FDA Finally Suggests Social Guidelines

After glacial consideration, the Food and Drug Administration has finally suggested some guidelines for how pharmaceutical and medical device manufacturers can use social media to market products and correct misinformation. Of course, they’re just “draft” guidelines, so they’re still not fully official, and don’t hold the FDA to it, because they might change -- but at least they’re there.

The marketing guidelines acknowledge that third-party social media venues like Facebook and Twitter often have limited space to explain products and make disclaimers (which, in other media, require two extra pages in a magazine or that guy who talks really fast at the end of the TV ad about discharges). 

However the FDA emphasized that drug and device marketers must still comply with the original rules governing promotional messages, including the requirement to give information about specific indications, and balanced disclosures about the product’s risks as well as its benefits in each individual communication -- meaning a statement about risks has to be in every Tweet, Facebook post, and so on. Whenever possible, special formatting should be used to highlight the risk information. If it’s not possible to cover all the risks, the most serious risks should be prioritized, including “all risk concepts from a boxed warning, all risks that are known to be fatal or life-threatening, and all contraindications from the approved product labeling.”

In all cases the company should also provide a link to more complete discussion of risks associated with the product; although the FDA doesn’t object to URL shortening, it recommends that the link to risk information indicate the nature of the information contained at the landing page, e.g., “www.product.com/risk.” Finally, if there isn’t enough room to make a reasonable disclosure about the drug (for example, when the risks are especially serious or complicated) on the social media venue, the company should reconsider using that venue to promote it.

In the second draft guideline, dealing with correcting misinformation on third-party sites (for example Wikipedia or discussion forums) the FDA acknowledges that given site constraints it may not be possible to make all the usual disclosures about a product while engaging with the site. In these cases, if the firm is not responsible for the original statement it is not required to make the full product disclosures in its statement, provided all the information in its own statement it provides is correct; the company should also identify itself as the source of the new information, and should not try to use the correction as an opportunity to promote the drug.

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