Help-Seeking Communications Guidance Withdrawn

FDA announced today (technically tomorrow) that they are withdrawing nearly 50 guidances.

One of these guidances has become a staple for ad-promo professionals who have turned to it repeatedly in the more than 10 years since its initial publication.

The notice in the Federal Register provides the following rationale for the withdrawal of these guidances:

Many of these draft guidances were not finalized most often because of higher priorities and resource issues. However, over the years, because of new information, scientific developments, and emerging technologies, a number of draft guidances have become outdated and therefore, should be withdrawn.

No further explanation is provided for the individual guidances listed.

Ad-promo professionals will be surprised to see the Disease Awareness Guidance on this list.* Since its publication in 2004, poring through this guidance has become a rite of passage for ad-promo professionals. The guidance itself has always been something of an odd bird in that it sets out a category of communications over which FDA does NOT have authority.

The basic idea is that FDA has authority solely over the communications that promote or provide instructions for use of drugs. FDA does not have authority over all other communications. Sometimes, companies are cited by the FDA for engaging in communications that the FDA deems to have been product promotion but which the company itself clearly intended to be some other form of communication.

This guidance sets out many of the criteria that FDA identified in 2004 as crossing the boundary from non-regulated to regulated speech.

Based on the limited information in the Federal Register, there's no way to know why FDA has chosen to withdraw this specific guidance document.

It is worth noting that there is not currently anything on the CDER Guidance Agenda that touches on this topic, so it appears that people promoting prescription drugs will be left without any guidance about what FDA considers inappropriate in this area.

* I'm posting this guidance on my own site because I'm assuming that FDA's site will no longer host the guidance as of May 6, 2015. My sharing this document should not be construed as endorsing the views set forth in it, nor should it be taken as a sign that these views represent FDA's current position. This link is merely being provided for historical research purposes.