FDA: Presenting Risk Information in Prescription Drug and Medical Device Promotion (2009) Draft Guidance – Coalition for Healthcare Communication Solicits Your Input

The Coalition for Healthcare Communication will be filing extensive comments  on the FDA draft Guidance and solicits your expert guidance in that effort. For immediate public comment, please participate in the dialogue in the Coalition’s LinkedIn Group: Click here to join the group and comment. If you are on the Coalition’s email list, you have been pre-approved to join the Coalition’s group.

To volunteer to participate in the formal Coalition comments, email: jkamp@cohealthcom.org.

While subject to some revision before final adoption, this should be treated at this point as being pretty close to a final document. Therefore, every drug and device company and every marketing partner needs to read the entire document and study this guidance carefully. A serious effort should be made to comply with its detailed proposals. For, like it or not, the safety of the nation’s drugs and devices is top of mind for the public today among both professionals and consumers. Moreover, advertising and other marketing tools covered by this guidance are among the important ways our profession will rebuild confidence in our industry and can help build patient adherence by communicating drug regimes that improve individual and public health.

Advertising professionals will instantly recognize that this guidance extends FDA’s unrealistic expectations of advertising and other marketing. Essentially this guidance demands nearly perfect messages and fully attentive audiences. The guidance expects the audience to be able to fully understand everything needed to either prescribe or initiate a doctor-patient conversation about a drug or device. As unrealistic as it is, that’s the FDA mandate, largely forced on it by the FDA Act, and reflecting the similarly unrealistic expectations of many citizens who are leaders of organized medicine, prescribers, patients and care givers.

Given these realities, the Coalition intends to (1) tell the FDA the truth about the realities of advertising, and to (2) make recommendations that will make the rules more realistic, practical and effective.

Most important, we look forward to a dialogue with the FDA that enables drug and device sponsors to communicate with prescribers and consumers more effectively about both the benefits and risks of health products.

We look forward to your recommendations and contributions to the Coalition comments. Remember, the FDA is a data and fact driven agency, so please include references to research and other scientific data wherever possible.

If you would like to join our discussion on this issue, please visit the Coalition’s LinkedIn Group.