In November, the FDA will host a 2-day public meeting on direct-to-consumer (DTC) promotion of regulated products, including prescription drugs. According to the September 13, 2005 Federal Register notice, the FDA is interested in hearing opinions on a number of topics relating to DTC. This hearing promises to be a prelude to new FDA rules governing DTC.

From the look of the questions the FDA is seeking comments on, I'd say any new FDA rules are likely to be very similar to the voluntary guidelines announced by PhRMA in August. If so, this would be a case of the hen leading the fox and would represent a victory for the pharmaceutical industry, which was criticized for not going far enough to reign in DTC advertising.

Or, you may look at it another way: it's always unwise to propose meaningful voluntary guidelines because it's likely to end up as mandatory government regulations. This may be why PhRMA was reluctant to go further with its guidelines and especially why the guidelines did not include a DTC moratorium period following a drug's launch.

Whatever! The important thing is to see what exactly is on the table that might lead to further regulations. This post to Pharma Marketing Blog provides excerpts from the FDA's notice -- with commentary, of course, to put things in [my] perspective and give you some more background information.

Make your opinion count. Take the "FDA Regulation of DTC Survey".

Read today's post to Pharma Marketing Blog.