Most FDA Warning Letters Issued Over Failure To Warn: Study

When a pharmaceutical company receives an FDA warning letter, it is usually a violation of rules regarding marketing of their drugs and failure to disclose potential side effects, according to an analysis by industry researchers. 

In a study presented last month at the Digital Pharma East conference in Philadelphia, a team of researchers from Johnson & Johnson found that most of the warning letters issued the FDA between 2013 and 2015 were because of failures to warn consumers about the risks of their drugs in promotional materials.

The FDA generally sends two types of letters: warning letters, which demand that companies take corrective action immediately, and untitled letters, known as notices of violations, which request a response from the company instead of demanding one. In many instances, both are referred to as FDA warning letters.

From 2013 to present, the FDA has issued six warning letters and 37 notices of violations to pharmaceutical companies. The researchers found that about 60% of these letters  and notices since 2013 have been for failure to warn violations in promotional materials such as commercials, pamphlets, and posts on social media.

They also found that a growing number of these were for social media promotions. While there were 26 actions for print materials during that time, there were another 19 for social media or mobile promotions that involved failures to warn.

The FDA issued draft guidance last June for some social media outlets which has become referred to as the FDA Twitter Guidance (PDF). In it, the FDA required that companies have to include the most serious side effects in any tweet or post about the drug’s benefits and also post a link to thorough safety information.

All of that information must be in the same posting or tweet, and the agency said if a drug company does not believe it can fit its promotion, most serious side effects and a link to safety information in a social media post, then it should look for another platform for its marketing.