How Onerous is DTC Pre-Submission?
“I do not see this guidance as a big deal.” -Bob Ehrlich
FDA just issued its draft guidance on pre-submitting DTC television ads at least 45 days in advance of airing. This is to ensure that FDA gets to see ads before they air for brands they feel might pose a risk if the information is incorrect. You may recall that critics say that once misinformation is public and by the time FDA takes action, the ad has already done damage. This 45 day rule helps FDA catch the problems
before the public sees it.
Not all ads will have to deal with the 45 day requirement. Most will, however, because FDA has a fairly broad requirement for categories of ads that must meet the 45 day rule. They include new products, new claims, highly risky drug categories, ads where a prior warning letter was sent, and anything else FDA might determine poses risk. So is this new requirement a burden to drug companies? Will it change the way DTC is done?
I do not see this guidance as a big deal. Most drug companies pre-clear anyway well in advance of airing. After all, no one wants to produce an expensive finished ad and have FDA kill it. Therefore at the storyboard or animatic stage ads are usually sent in for an advisory opinion. The new guidance seems reasonable and as long as FDA is not unreasonable in what they find objectionable, it seems like a benign requirement.
Drug companies will need to develop ads early enough to make sure they can send ads in well in advance so any FDA changes can be incorporated prior to airing. The practical effect is that ads will need to be submitted 90-120 days in advance of air date. FDA will usually suggest changes so a brand team needs plenty of time to re-record voiceovers, fair balance reading, supers, etc.
The old regulations did not require advance looks at ads. They needed to be sent concurrent with air date. The problem of course was violative ads actually aired. This new requirement should prevent this from happening. That would help FDA, the public and drug companies who would avoid embarrassing warning letters and the critics’ inevitable outcries.
I know the advertising industry may see this as a slippery slope. Today 45 days, maybe 90 days in a year, 180 days next year. They also fear outright pre-clearance which would require official FDA approval. I am not concerned about this problem. Whether one calls it pre-submission, pre-clearance, pre-approval it is the same thing in practice. Drug companies need to show FDA the ad in advance and make changes that FDA asks for whatever it is called officially. Drug companies that try to go around FDA have historically been hit with warnings and penalties. So, I urge drug companies to start the copy development early enough so they do not face the dilemma of hoping they have time to make changes.
DTC copy development should start about 18-24 months prior to expected air date. That will help with FDA review but also makes good business sense as numerous refinements based on consumer feedback takes time. In the average 60 second ad you may have 25-35 seconds of sell copy and every second counts. Too many drug companies wait way too long before selecting the DTC brand team and agency. Layering on this new FDA requirement should incent drug companies to start sooner and that is a good thing.
Bob Ehrlich, Chairman DTC Perspectives, Inc