DDMAC BUSTS J&J FOR ULTRAM MARKETING

Stop Doing it; Show Remedial Plan

In a detailed warning letter, DDMAC has demanded that J&J stop marketing Ultram through materials that minimize the drug's risks and overstate its efficacy. The warning letter can be found here:

http://www.fda.gov/cder/warn/2009/Ultram_ER_Warning_Letter.pdf

Some of what is interesting about it is that the letter calls for evidence of a remedial plan as well as ceasing to use the materials. The relevant section reads:

"Because the violations described above are serious, we request, further,
that your submission include a comprehensive plan of action to disseminate truthful, nonmisleading, and complete corrective messages about the issues discussed in this letter to the
audience(s) that received the violative promotional materials."

It is a single example, but it is one of others in which companies are being required to send out materials to _correct_ problems with earlier marketing. It is also of a few that suggest that the days of deregulating DDMAC, which reached a peak during the Bush administration in which the number of such letters dropped by roughly 600%, has come to a close.

In connection with earlier threads, it also suggests the different kind of FDA which is under construction.