In his , Peter Pitts wrote the following overview of Day 2 of the FDA hearing on social media. He highlighted the diverse views and concerns of witnesses on the subject of “adverse event” reporting and publicity.
Adverse event generation is the real bête noire of social media.
Should companies actively avoid participation — even to the degree of monitoring — lest they uncover an adverse experience? Shouldn”t companies embrace social media so that adverse experiences can be found with greater alacrity? Shouldn”t companies be rewarded for such behavior? If regulated industry wants the FDA to be both regulator and colleague, then it”s not a leap of faith to imagine that the FDA would like industry to be proactive in its search for new ways to surface adverse events.
I know of 1 large pharmaceutical company whose policy is not to monitor social media sites because they don”t want to unearth adverse events. Is this responsible? Is it even supportable? If this company received a call from a reporter and was asked if they purposely avoid social media so as not to find adverse experiences, would the truth set them free? Legally they may be in compliance, but it wouldn”t look good on page one or sound very good in front of a congressional subcommittee. “In compliance” and “in the best interest of the public health” must not be mutually exclusive propositions.
Read the rest of Friday”s summary on .
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