Companies have to watch the messages they send on their website and in social media channels.  In a recent letter to Bracco Diagnostics, the FDA alleged the company made unfounded claims about its diagnostic agent Isovue, and even minimized or outright omitted its risks on their website.  The FDA’s letter contends that the claims were based on a clinical study, as opposed full-blown prospective trial for Isovue.  According to the company, those web pages were taken down, but it remains to be seen if any legal action will be filed.

Lawsuits and fines did not escape Kimberly Clark’s I-Flow division, which allegedly encouraged doctors to use its OnQ Pain Buster infusion pumps following arthroscopic surgery.  This intra-articular use of the pump was not approved by the FDA, and so far the case has cost Kimberly Clark $4.75 million. These are not isolated events.  In fact, other manufacturers face similar lawsuits and impending action by the FDA as it seeks to devote more time and money towards enforcement of regulations.

According to the latest public documents, the FDA is looking to raise its budget for the medical device division (CDRH) to $1.4 billion, an increase of over $100 million.  With the request for over 1,000 new employees, the FDA may soon have the capacity for monitoring labeling much more closely.

Most device makers are careful not to promote off-label use, but FDA may soon want them to be more of when it is occurring.  This includes monitoring social media sites for information being exchanged between users promoting off-label use.   The FDA has stated in recent communications and at its public meeting on the topic, that they are monitoring social media sites for issues like off-label use and patient harm.  That information is being fed right back into the inspection process as part of the criteria for judging a company’s regulatory compliance.

Even companies that are doing all they can to comply, need to be aware and active in online social networks.  If companies want to avoid enforcement actions and costly legal disputes, they will need to remain vigilant in the digital social world.