Wednesday, November 2, 2016

Brief Blog: FDA to Hold Workshop November 9-10 on Communications of "Unapproved Indications"

On November 9-10, FDA will hold a two day public workshop on communications about "unapproved indications."   This is the next step in a long-standing saga about the balance between First Amendment speech rights and the FDA's labeling authority and review process.

The workshop registration is closed, but it will be videocast.  The FDA webpage is here.  An article at FDA Law Blog is here, focusing on the evolution of FDA policy, some court cases recently lost by the government, and providing additional links.   (For a colorful 12 page discussion of the recent Vascular Solutions case lost by the government, by Duval FDA Law, here.  I had a chance to do some consulting for the winning side.)

The topic was featured in a NEJM op-ed on November 3, 2016, here.  For a trade journal's meeting preview, here.  For fairly detailed coverage at, see here.