CardioSource WorldNews | Page 35

“We understand that communicating on electronic Internet sites with character space limitations can be challenging,” wrote Thomas Abrams, MBA (@fdacder, 0 Tweets, 31 followers), the director of FDA’s Office of Prescription Drug Promotion in the Agency’s Center for Drug Evaluation and Research (CDER). “But, no matter the Internet source used, benefit claims in product promotions should be balanced with risk information.” The FDA has also issued guidance on how industry entities should go about correcting misinformation related to their drugs or products found on third-party Internet and social media sites. “In health care, we have issues, we have recalls. The ubiquity of social media gives us the chance to spread the word and save lives instantaneously,” said David E. Albert, MD (@DrDave01, 42.4K Tweets, 10.5K followers), chief medical officer at AliveCor in San Francisco and inventor of the AliveCor ECG. “But we have to be responsible in its application. Obey the rules, but take advantage of its power.” At the 2014 ACC meeting, Dr. Albert related his personal experience with social media when he first invented the AliveCor ECG and his 4-minute video, meant for his 4 Twitter followers went viral, unleashing “a global #SoMe viral epidemic.” Within days he was asked to appear on ABC, CNN, Fox, and NBC and received calls from the likes of Eric Topol, Sanjay Gupta, and Leslie Saxon, and…the FDA. The latter weren’t too happy about a viral video promoting an unapproved product. In SoMe parlance, he was #clueless. He admitted, “What I did was ‘inappropriate’ promotion of a non-cleared medical device, but it was an unintentional accident and I did not further ‘PROMOTE’ the commercialization of the product until I had FDA clearance.” Not afraid to act against bad Tweeting, in August 2015 the FDA ordered the maker of a morning sickness pill to remove a post by Kim Kardashian because it was “false or misleading” in that it presented efficacy claims but failed to communicate any risk information or state clearly the approved indication for the drug, specifically that it has not been tested in women with hyperemesis gravidarum. At t