“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.
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