Help-Seeking Guidance Withdrawal Update

Last week, FDA withdrew 47 guidance documents, including the disease awareness guidance that has become so central to ad-promo professionals. As I mentioned at the time, this move left those of us who care about these issues in a bit of a quandary.

It certainly seemed from FDA enforcement activities and other statements that many (if not all) of the principles set forth in that guidance still represented FDA's view, but the guidance itself was technically no longer an official statement of FDA's position.

Since I was teaching a two-day ad-promo class for FDAnews this week, I reached out to OPDP about whether I needed to radically alter my treatment of the topic of disease awareness in light of this development.

I received the following statement in response:

FDA continues to believe that disease awareness communications can provide important health information to consumers and health care practitioners, and can encourage consumers to seek, and health care practitioners to provide, appropriate treatment.  While many of the principles in the withdrawn draft guidance are still relevant, we are taking this opportunity to work on an updated draft guidance that considers new technologies and includes information about social science research to better reflect FDA’s current thinking on help-seeking and other disease awareness communications.

I'm sharing this with the community because I think it provides important amplification on the initial withdrawal statement.

FDA is apparently working on a new updated draft guidance (despite that guidance not being listed on the 2015 guidance agenda). Also, FDA continues to endorse the view that disease awareness communications are important and can improve the public health.

I'm particularly excited to see what FDA has to say about new technologies. The 2004 guidance was silent on the use of the Internet, and as readers of this blog might know, I've been curious about this topic for several years.

So stay tuned. Clearly there's more coming.