FDA Announces New "Draft Guidance"; CHC Solicits Your Participation in Formal Comments

Discuss this issue with other healthcare communication professionals in the Coalition’s LinkedIn Group

May 26, 2009 — FDA released extensive “draft guidance” today on how advertisers must include risk information in drug and device advertising aimed at consumers and professionals. While critics and supporters of drug marketing will find much to both love and hate in this new guidance, the FDA  makes it crystal clear that the central message of every ad must include risk information that is clearly and forthrightly stated in language that is suitable for the audience being addressed.

The full notice is available here

Comments are due in 90 days, after which the FDA will release final guidance.

The Coalition for Healthcare Communication will be filing extensive comments and solicits your expert guidance in that effort. For immediate public comment, please participate in the dialogue in the Coalition’s LinkedIn Group. 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.

Although subject to some revision before adoption, this document is close to being finalized. 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 America’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 caregivers.

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

Most importantly, 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.

Meanwhile, watch this space. We expect to provide a variety of expert commentary on this docket, as well as advice on how to comply with this new guidance.