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World Congress mPharma Summit | July 21-22, 2015 | Boston, MA

Monday, July 21, 2014

FDA's Ten Commandments

Remember FDA's Social Media Webinar?

It was supposed to answer all our questions about the two recent social media guidances issued by the FDA.

There were technical difficulties and when participants could actually gain access and hear what was being said, they were surprised that the FDA presenters were simply reading the guidance documents verbatim.

"The #FDASM webinar, a haiku: Reading verbatim. Good use of my precious time? I'm not sure it is," tweeted @whendanieltalks.

This reminded me of Moses reading the ten commandments to the Israelites, who afterward agreed to obey those laws. Whether or not the pharma industry will obey the current drafts of FDA's "ten commandments" remains to be seen. Personally, I think the industry wants to send Moses, er, Abrams, back up the mountain.

If FDA actually had ten commandments, these might be them:

  1. You shall have no other regulatory agencies before Me.
  2. You shall not make fun of Me like Pharmaguy does.
  3. You shall not take the name of the FDA your Regulator in vain, especially at industry conferences.
  4. Remember April 2, 2009, the day of the 14 NOV letters, to keep it holy.
  5. Honor your regulatory and your legal departments, even if they say No all the time.
  6. You shall not promote drugs without required ISI, period!
  7. You shall not commit other FD&C violative acts.
  8. You shall not steal, unless it's a cure for Hep C.
  9. You shall not bear false witness against your competitor - but snitching via My BadAd program is OK.
  10. You shall not covet your competitors' Notice of Violation Letters.
After the webinar, FDA did provide a Q&A list (find it here).

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