The latest from OTC Perspectives

News From DTC Perspectives - PhRMA's Incrementalism

On Dec 10, some modifications were announced to the DTC PhRMA 2006 code. The original code had good intent and did address some of the criticisms of DTC. The latest changes, of course, should have been in the original code. They are fairly obvious and somehow were too “radical” to appear in the original.

Let's take the modifications highlighted in their press release one at a time. The numbering is mine as the PhRMA press release did not have them numbered. I have summarized each of the changes in one sentence. You can see the full press release and all revised guidelines at www.phrma.org/news.

1. There should be disclosure on whether a portrayed health care professional in ads is an actor or a real medical professional.

OK. That is certainly a good idea but not something that should have taken another 3 years to articulate. The original code was followed by a number of more informational ads that had doctor or actor portrayed doctor spokespersons. The time to add this provision was then. Better late than never I guess.

2. When a celebrity is used to endorse a product, the ad should accurately reflect the endorser's opinion and use of the product.

Hmm. That means the endorser should be telling the truth when they say drug X saved their life. Another dramatic step I see. It also follows years of criticism about celebrities overstating benefits and appearing on talk shows without disclosing they were being paid by drug companies. Again why so long after the criticisms has this part of the code been introduced?

3. The print ads should follow the law that requires a Medwatch phone number for consumers to report side effects to FDA.

That is interesting. We need a principle that says follow the law. Ok, if that helps I am for it.

4. Companies should consider allowing time before DTC starts to educate medical professionals.

The dreaded moratorium concept is not raised explicitly here but I guess is meant to be part of this modification. The most important issue to Congress cannot even be mentioned by name. Of course PhRMA does not give guidance as to how long of a delay is enough. No comment is made on whether the 6 months agreed to by several big drug companies is adequate. PhRMA once again ducks the core issue. It would be much better if PhRMA could get some agreement on a specific moratorium time frame for new drugs. I would suggest 6 months for new drugs in existing drug classes and a minimum of one year for new drug classes. Congress wants 2-3 years for new drugs but I am sure if the industry could adopt a sensible voluntary time frame Congress could be satisfied.

5. PhRMA expanded on its language on age appropriate content for adult drugs such as erectile dysfunction products to be defined as programs drawing audiences that are 90% over age 18.

This whole issue relates to showing ED ads during the day or early evening. Many moms and dads were embarrassed explaining 4-hour erections to their 8 year olds. I guess this is a decent modification although having 10% of the audience under 18 still allows for thousands of little ones still asking embarrassing questions. I do have some sympathy for the drug companies on this one. Many men in the target audience watch daytime sports and that programming is also seen by kids. I guess the sexually suggestive beer ads are all right with mom, as are the triple X violent video game ads; but mentioning the sex act is just way too much.

6. Benefits and risks should be stated in equal balance and in a neutral manner.

Once again that is the law. This is one of those meaningless modifications. I do not see how this gives any helpful guidance to drug marketers. I still see no guideline on requiring only patient friendly brief summaries, something I have been asking for over the last decade.

The PhRMA press release also added some additional changes such as requiring drug companies to get feedback on ads from healthcare professionals during the copy development process. PhRMA also asks that drug ads have a mention of programs to help the uninsured. Both of these are sensible.

I might seem overly cynical on the value of the changes. I am just frustrated that PhRMA is always one step behind dealing with criticism. Announcing these new guideline modifications is fine but does anyone think Henry Waxman will be any happier and cancel the hearings? These are slight changes on common sense guidelines made three years after the original guidelines, which were developed 10 years too late. Forgive me for being a bit critical of PhRMA's role or their sense of urgency.

Maybe I expect too much from the organization designed to protect and promote DTC. Of course PhRMA is only as strong as its members so I guess I am criticizing big pharma for taken tepid stances on important issues. That these revisions took three extra years is a sad commentary on the glacial pace of self-regulation. No one wants DTC to survive and thrive more than me.

I am afraid our lobbying group does not promote confidence that they can prove they can self-regulate effectively. I urge the pro-DTC drug CEO's to deal more aggressively with the real issues of length of moratoriums and appropriate risk disclosure. Otherwise Mr. Waxman will develop the guidelines, rules, and prohibitions for DTC and that is not a solution any of us will likely find helpful.