New FDA Guidance

>> Thursday, June 11, 2009

My friend Bob Ehrlich from DTC Perspectives and OTC Perspectives has a great point-of-view on the recent advance on new FDA Guidelines. I like Bob's perspective because he's not sounding any alarm bells, yet is acknowledging a new day in FDA regulation for prescription drugs. He's pretty level-headed and full of common sense, which I appreciate.

You can read Bob's comments here, directly on the DTC Perspectives website:

Here's my take away, from both the new guidance and from Bob's great assessment:

1) Take a look at the totality of the marketing communication. Is it balanced in terms of product claims and associated risks? What is the net take away for the consumer? Is the brand promising more than it can deliver and does the consumer understand both sides of the equation?

2) In testing, make sure that you're looking at the totality of the communication (as stated above), not just the benefits. We tend to focus our efforts on product positioning, claims, and creative approach in our testing, and perhaps that's only one side of the communication.

3) Get pre-clearance from DDMAC and build it into the timetable. Always.

4) Not just for print and tv anymore -- all vehicles should be looked at from the same perspective of totality of communication. While a lot of this guidance focuses on tv and print, we know that digital, crm, retail, and all other channels are under the same scrutiny.

5) Don't be surprised when the questions come from the FDA. Increased scrutiny means more questions and a more constant dialogue between the FDA and marketers. There's nothing wrong with that, let's collaborate.

5) Not just for prescription drugs --- all products that talk health will eventually face the same guidance, or so I believe. Embrace it and thrive within it. The lines are blurring and good health does not just come from prescription drugs.

Hope this finds you well -- Jim.


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