FDA, Off-Label Uses and the Internet – Something New for 2012 (Well sort of)


It is the end of the year – a time to look back and reflect and a time to look forward and ponder. We’ve already looked back and posted about the best and worst prescription pharmaceutical and medical device cases of the year. So, on this the last posting-day of 2011, we’d thought we’d look at something aimed toward the future – FDA’s Guidance for Industry Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices. As this is just a draft guidance right now, we don’t really know what the future holds, but we thought this looked a bit like an FDA New Year’s Resolution – FDA resolves to admit the internet exists and to figure out what to do about it. We just aren’t sure they are going about it the right way. Sort of like resolving to lose weight, but going about it by cutting back to only 2 doughnuts per day – it’s really not going to get the job done.

Off-label promotion – just the words leave our clients shivering. Pharmaceutical and medical device manufacturers walk a fine line between providing current, relevant, and accurate medical information to their clients (health care professionals) and being accused of violating FDA regulations against off-label promotion. Even the FDA admits that...

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