The recent release of the long-awaited draft guidance on risk is sure to have drug marketers studying the lengthy and nuanced 27 page document. I give DDMAC a lot of credit for attempting to better define what is acceptable and violative in print and television ads. They tried to add some meat to previous guidances so marketers and internal drug company regulators can understand what FDA will be thinking about when they screen ad submissions.

My net takeaway is that FDA will be much stricter on balancing benefit and risk claims in the future. They make a point of saying they are looking at the totality of the ad to determine if it meets the required standards of fair balance. This gives them the old “I’ll know it when I see it” defense to consider an ad unbalanced. I like the fact that the latest guidance gives numerous examples of how an ad can provide balance. I also get the sense that a new FDA sheriff is in town and is going to be giving out more tickets.

The FDA expects that benefits and risks will be balanced not only in the number of words but in how those words are written or spoken. This means that you cannot have large type for benefits and small type for risks. You must not obscure the risks with visual distractions or lively music. You cannot use medicalese when a layman’s word is available. The latest draft guidance is filled with examples and explanations of good and bad ads.

Is the guidance going to be helpful to drug marketers and their agencies? I would expect that the guidance will make marketers more careful about what they test. Clearly many of the ad tests in the early stages focus only on benefit statements. The guidance should incent marketers to spend more time showing concepts with risks and side effects included. It should also point out how necessary it is to start copy development much sooner. Too many companies wait too long to begin ad development and then rush the details which includes risk copy. Given all the copy landmines DDMAC is placing, it will take at least 12-15 months from start to finished ad.

This guidance also makes it imperative that all ads are pre-cleared. There are just too many subjective calls to be made by DDMAC to assume your ad will pass muster. An ad not sent in is an ad asking for a warning letter. The new FDA will be looking to punish violators with corrective advertising. Those who run ads looking to avoid FDA pre-clearance are going to regret it. Hopefully FDA will have the staff to offer timely pre-clearance reviews.

I am sure the new draft will get many comments from agencies and drug companies. It is likely, however, to be implemented without many changes. Marketers and their agencies would be wise to study it(www.fda.gov/cder/guidance/7427dft.pdf )and review current ads in the context of the new guidance. I doubt FDA will be re-reviewing ads they already screened and approved, but watch out in the future. My guess is the newer ads will look and feel very different as FDA strips out the imbalances. That will be a downer for agency creative folks, as internal drug company regulatory and legal reviewers wordsmith copy and criticize layout.

The draft guidance is meant to clarify but I also suspect it is intended to signal increased FDA vigilance under the new leadership in Washington. It will make for challenges in creating DTC ads but not so severe as to discourage DTC as we know it.

Consumer Reports, a publication I have long respected, has been very critical of DTC for years. They have recently started a periodic web review of individual DTC television ads where they deconstruct product claims. The process they use is to have correspondent Jamie Hirsh interrupt the reviewed commercial with video commentary as well as a blog.

The latest review is over Sally Field in the Boniva ad.  Ms. Hirsh takes issue primarily with Boniva’s price. She says other drugs work well for osteoporosis at less cost. The only difference is that you take Boniva once a month says Ms. Hirsch versus weekly or daily for other drugs. Of course that monthly dose is what Boniva is pitching in its ad. The once a month dose is a big benefit since all drugs for osteoporosis may cause upset stomach and require not lying down for up to an hour after taking the pill.

Ms. Hirsh worries aloud about the ethics of using a celebrity and wonders about sally Field’s real use of the drug. She also seems to poke fun at Ms. Field’s air style and that she “looks refreshingly younger than her actual age.” I did not know looking good is a problem in advertising. Would she be happier with a celebrity who looks older than her age?

The web piece is titled “Sally Field and Boniva-Great spokeswoman, misleading ad.” I could not find anything which supported the “misleading” portion in the title. Nothing in the ad misleads consumers unless you believe somehow Sally Field is not using the product. The fact is that Boniva’s claims are vetted by DDMAC for misleading statements. If there are any misleading claims I suggest Ms.Hirsh make her case to DDMAC but that would take facts, not silly reactions to Sally Field’s age or hair.

I guess Ms. Hirsh would like the Boniva ad to point out that other drugs are available at lower cost. I think it would be nice if all companies told you what else is available from competitors, but then that would not be advertising. Advertising is designed to sell products. Given DDMAC , physicians, and competitors are involved, I think the consumer will have ample chance to get alternative drug information.