New FDA Pre-Dissemination Guidance
“This guidance is a pain..but will not result in the end of DTC TV.”
The FDA has received many comments from drug companies concerned about the dissemination of final commercials before they air. The draft guidance was issued on March 13, 2012. It basically called for a 45 day review period of final ads prior to air date. Drug companies responded in the FDA comment period ending May 14.
The drug industry comments show concern over the final ad requirement because changing a final ad is expensive and time consuming. In fact one drug company, Sanofi, said it may stop DTC television because of the burden.
PhRMA says the guidance may be unconstitutional because it is overly broad and could restrict commercial speech. Courts have sided with industry on commercial speech in that anything that is a burden on it must be absolutely necessary and the only way to do it.
FDA has said that voluntary pre-review is a way for drug companies to avoid later re-editing of final ads. If an ad is submitted in animatic form, for example, FDA could alert the drug company to problem areas in advance and this should avoid errors in final cuts.
So do the drug companies really need to be so concerned with this guidance? Is it a potential DTC TV ad killer? Is there a better way to do it?
Drug companies have a right to be worried. After all, it is expensive to film an ad and hope it is all right with FDA. Re-shooting is enormously costly. The issue here is will FDA make unreasonable demands for ads after it is shot? My experience is most of the FDA complaints are with how risk is presented. They find the visuals during the risk presentation distracting, or the announcer voice is going too fast or supers are conflicting with the oral portion. Most of these are not expensive changes, even after the commercial is shot. If FDA objects to the way actors or real consumers/doctors read their lines or object to the setting; that can be very expensive to change.
My feeling is that the vast majority of final commercials will not be altered significantly. Just a guess but FDA is unlikely to undo an entire commercial, especially if one is sent prior in storyboard or animatic form. Few drug companies will risk shooting an entire ad without voluntary pre-review. Therefore, in practical terms, the hard part, which are the claims and major risks have already been reviewed as well as the ad setting and key visuals.
I know the drug companies are worried that any pre-dissemination is a slippery slope and could lead to more restrictions down the road. That is a valid concern. This is especially true if government wants to make it harder to sell branded drugs, which under Obamacare is likely a goal for cost control reasons. Today’s guidance could morph into requirements that make DTC TV too hard to execute. My take is that if the current draft guidance were all there is, then DTC TV will continue, albeit with a need to finish the process earlier and sit on pins and needles waiting for final approval. Drug companies will adjust and live with the pre-dissemination requirement. It will make media buying harder because timing is less certain. That means, drug ads will probably be on-air a month or two later than they are now. Drug companies will build in some delay time in their media schedule to avoid canceling ad buys.
Is there a better way? I would have required a final animatic and or detailed story board with an audio track, instead of final ad. The FDA could catch 99% of problems this way. Final ads usually closely match the storyboard or animatic. FDA does not seem to understand how hard it is to arrange and manage live shoots. Any significant change is a burden to drug companies and hopefully the voluntary submission process will identify all those issues well before final shooting of the ad.
My net is this guidance is a pain to administer but will not result in the end of DTC TV. On the other hand, is it really a regulation that is needed to prevent public harm? If FDA prevents 99% of incorrect information from occurring by seeing storyboards, isn’t this enough? My experience is the most egregious ads later cited for violations were not submitted for voluntary pre-review. Therefore drug companies should use this voluntary process. To catch the rare violator should the other 99% be forced to submit final ads prior to air-date? No, in my humble opinion.
Bob Ehrlich, Chairman
DTC Perspectives, Inc.