By John Kamp

April 9, 2012 – The only thing really clear about the new guidance on pre-review of the DTC advertising is that advertisers and their marketing agency partners will need to ensure that their FDA submissions include detailed claims substantiation for every ad submitted. Beyond that, the analysis and commentary on the FDA guidance ranges from “not much new here” to near hysteria.

In fact, my first reaction – suggesting new, extended review delays as well as pre-reviews of virtually all TV ads – was likely an over-reaction. Most importantly, industry has been submitting most ads for pre-review under the PhRMA self-regulatory code for several years, making many of the FDA requirements old hat for industry. Indeed, the draft guidance implements requirements of the last PDUFA reauthorization, Food and Drug Administration Amendments Act, largely supported by industry and trade associations.

Regardless, seldom have I seen such a broad divergence of views on the meaning, scope and impact of a draft guidance from FDA marketing officials.

Although a first reading of the draft guidance appeared to affect nearly all DTC TV ads, the FDA recently responded to an article in “The Pink Sheet” DAILY that its pre-dissemination review policy would involve only 25 percent of DTC TV ads. Thomas Abrams, head of the FDA Office of Prescription Drug Promotion, told the publication that the 75 percent of ads excluded from pre-review “consist of TV ads for products that were already advertised on TV and do not fall into any of the categories stipulated in the guidance.”

In spite of that response and in light

of the guidance’s inclusive list of ad categories subject to submission to the FDA, veteran FDA attorney Arnold Friede believes that drug sponsors will find it difficult to identify TV ads that would not require pre-review, especially because of the “catch all” category defined as “any TV ad that is otherwise identified by FDA as subject to the pre­-dissemination review provision.”

In a recent article in InsideHealthPolicy.com, Friede stated that the guidance “is in line with FDA’s ‘desire to control prescription drug promotion,’” and that its de facto prior approval for TV ads raises “some pretty serious statutory issues and constitutional issues.” However, in spite of the clarification by FDA on the scope of the draft guidance, regulatory and legal experts still may counsel clients to err on the side of caution and submit nearly every ad.

I suspect the draft guidance will spark some interesting comments. Indeed, the guidance may be challenged under a provision in the FDA statute limiting pre-reviews, or perhaps even more dramatically as a violation of the “prior restraint” limit on speech under the First Amendment.

And then there are the substantiation requirements. The content of the dossier that the agency is requesting sponsors to submit is much more comprehensive than in the past, even though such data is routinely compiled by companies for internal purposes.

Although there is some debate on the details of the new requirement, the draft guidance calls for the substantiation package to include an annotated storyboard of the proposed TV ad to show which references support which claims. However, the agency specifically states that the storyboard alone cannot be evaluated by the FDA to determine whether a TV ad is acceptable.

“The FDA cannot provide final comments on the acceptability of a TV ad without viewing a final recorded version in its entirety. FDA understands that some sponsors may wish to receive comments from the Agency before producing a final recorded version of the ad,” the draft guidance states. “In such situations, sponsors can submit a pre-dissemination review package without a final recorded version of the ad, but once the final recorded version is produced, it will need to be submitted to the Agency for pre-dissemination review.”

This could create a very difficult choice. Either submit story boards and risk that FDA will fault the final version, or produce the ads ahead of the pre-review and risk repeating the time and expense of the production.

For most companies, the process for having ads vetted by the FDA will include the following steps, according to Bruce Grant, Senior Vice President, Strategy, DigitasHealth:

(1) Submit pre-production concepts for advisory comments

(2) Produce the spot incorporating FDA comments

(3) Submit the finished spot plus the “substantiation package” for pre-dissemination review

(4) Wait 45 days, during which hopefully you will receive any additional comments back from FDA

(5) Re-submit the spot to FDA with Form 2253 and traffic to air.

This process adds another layer to the TV production workflow, but “incorporating FDA advisory comments from pre-production review should substantially mitigate – though not eliminate – the risk of unexpected comments coming out of the 45-day pre-dissemination review,” Grant said.

A potential and perhaps likely glitch is that the FDA draft guidance does not list a time frame in which the agency would provide pre-production advisory comments.

Bottom line, industry should review the draft guidance very carefully and send its comments on the areas it perceives to need revision as soon as possible. The FDA really needs to understand the impact of this document on both the advertisers and the patients they are trying to reach with valuable information about new treatments for their health conditions. The deadline for comments is May 14. Agencies and publishers wishing to assist in formulating the Coalition’s comments should immediately contact Jack Angel at jeangel@cohealthcom.org.