FDA's long-awaited Twitter guidance gives biopharma certainty and constraints

The FDA continued to build its patchwork quilt of social media guidance this week with the publication of two new draft documents, one of which is the long-awaited discussion on how to use Twitter ($TWTR). And while the guidance places significant constraints on how biopharma can use the platform, some think the clarity it brings will prompt companies to become more active tweeters.

The guidance on using platforms with character and space limits--which includes Twitter and search adverts like those offered by Google ($GOOG)--calls for drugmakers to include risk information in each post about a product. As Regulatory Focus notes, this prevents companies from firing out a series of tweets, some of which focus on marketing the drug, others of which cover the risk of side effects. Writing out the risks each time will eat into the 140 characters Twitter allows for each post.

While the requirement clearly constrains the use of Twitter, the fact that companies finally know what the restrictions are could actually encourage more drugmakers to tweet. Lori Leskin, a partner at the law firm Kaye Scholer, expects an uptick in biopharma activity on Twitter, but told Bloomberg some products will be excluded. "It's the more significant drugs that do have black box warnings, that do have more significant risk, that are used in limited populations that this won't be appropriate for," she said.

FDA also posted draft guidance on another of biopharma's long-standing internet bugbears: How and when misinformation may be corrected. With companies unsure whether responding with anything other than full prescribing information could land them in hot water with FDA, some have shied away from pointing out even the most blatant of falsehoods. Now FDA has given companies a checklist and series of examples to help them understand how to appropriately correct misinformation when necessary.

- read the Bloomberg article
- here's Regulatory Focus' Twitter piece
- and its misinformation coverage

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