Actually, I’m going to step away from the usual Weekly Roundup format to look at our stocking.
Is the stocking empty, or is there something rattling around it yet to come?
For those whose priority was to receive the FDA draft Guidance on the Internet and Social Media, you will find it empty. You must have been naughty.
For those who really wanted to see the FDA get authority to expand authority into new areas, you have the regulation of the agency over the marketing of tobacco and you have a true Christmas surprise, the passage of the Food Safety Modernization Act by a Senate that suddenly woke up to realize it had a job to do – well you have something very substantial in your stocking. You all must have been real nice.
If you were hoping for a regulatory pathway for biosimilars, you were probably jumping the gun and have an empty stocking, and you will have next year too it would appear.
And for patients, it is a mixed stocking – with some new medicines approved, while others went away.
More on looking back at the year past, and forward to the year to come later next week. In the meantime, let me wish you all a wonderful holiday and wishes that you do get the things you want most of all in the way of good health, good fortune and peace.
