S&R Blog

Calling all pharma marketers… the FDA wants to hear from you!
June 4, 2009, 1:22 pm
Filed under: pharmaceutical marketing | Tags: , , , , ,

In pharmaceutical advertising, we find ourselves in a state of constant regulation as everyone tries to ensure each piece created meets FDA requirements. This struggle between advertising the benefits of a drug and satisfying the necessity to indicate the risks (in increasingly larger quantity and size) is one we face daily. With the recent release of the draft form of Guidance for Industry Presenting Risk Information in Prescription Drug and Medical Device Promotion , a set of non-binding recommendations for print and broadcast promotion, the FDA is attempting to help us along. The stated goal of the draft guidance is to clarify the factors the FDA considers in evaluating ads and promotional labeling for prescription drugs and restricted medical devices.

Overall, the FDA is clarifying the presentation of risk information so that it is equivalent to the presentation of benefit information, which is nothing new. But they are doing this by including more detail and examples. Their examples and occasionally vague language indicate how tricky this situation can be, not only for advertisers but also for the people doing the regulating.

One of the most exciting aspects of the draft guidance is the fact that the FDA will be accepting comments and suggestions for a 90-day period. Though no one can say for sure if the FDA will implement the suggested changes they receive, now is the time to review these draft recommendations and share your thoughts. If you think the examples they provide are not sufficient, you should request more, better examples. If you think their recommendations aren’t practical, you should tell them that and explain why. Maybe they’ll agree. We now have the opportunity to perhaps gain some control over a situation that affects pharmaceutical companies and advertisers daily. We shouldn’t let that opportunity pass without at least trying to make a difference.

Comments and suggestions can be submitted until August 24, 2009. Be sure to include the docket number, FDA-2008-D-0253, from the notice of availability that came out on May 27, 2009.

Send comments to
Division of Dockets and Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852


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