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CDER guidance plan for 2016 – links still on the list


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CDER has once again released their list of planned guidances for 2016, just like they did for 2015, and the list once again has the much-anticipated link guidance, plus one on off-label communication:


Link guidance

We failed to get this guidance in 2015 so there is a good chance it will make its appearance in 2016. Links are a big topic in online regulatory discussions so it’s not that surprising that the FDA is taking the time needed to get it right. The topics we’re hoping to see addressed are the same as a year ago when we wrote about this:

Just like in 2015 we’ll be on the lookout for this draft guidance as it has the potential to shape how much of our digital and social properties interact with the rest of the internet.

Off-label guidance

The recent legal actions by Amarin and Pacira have weakened the FDA’s absolute prohibition on off-label materials. It looks like the regulator is planning to release some draft guidelines for marketers in the handling of legitimate, “truthful and non-misleading,” off-label information.

This information won’t be specifically digital-focused, but it will be critical for all pharma marketers to understand it. How the FDA reacts to this erosion of its powers will make for fascinating reading. As always, we’ll be on the look out for it.

Other guidances

Other guidances in the list that are important for digital healthcare marketers:

Source: FDA.gov

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