The US pharmaceutical trade association, PhRMA, finalized its “Guiding Principles” for TV and print direct-to-consumer (DTC) advertising yesterday (see “America’s Pharmaceutical Industry Announces Guidelines on Direct-to-Consumer Advertising” for the announcement; the principles themselves can be found here).

The Wall Street Journal reported that “Twenty-three companies — including Eli Lilly & Co., Merck & Co., Schering-Plough Corp., Pfizer Inc. and GlaxoSmithKline PLC — have said they would adhere to the principles.” (See “Drug Industry Creates Voluntary Ad Guidelines“).

I first reviewed these principles before they were finalized and noted some drawbacks (see “PhRMA Rules Come Up Short“). Now that I have the details, I will revisit my comments and expand upon them.

PhRMA had been working on these “guidelines” for some time and as recent as 2 months ago a knowledgeable person told me not to expect final release of the guidelines any time soon. My source indicated that there was a lot of differences of opinion among member companies.

This all changed when Sen. Frist called last month for a 2-year moratorium on DTC advertising (see “Deconstructing Frist on DTC“). That really put a fire under PhRMA hotter than any Democrat could. As Billy Tauzin, head of PhRMA, stated in a WSJ video interview: “Senator Frist was right. And I want to thank him for adding a lot of momentum to the effort to begin changing the [drug] ads in America.”

I don’t think I’ve ever heard a PhRMA representative admit a senator was “right” especially when that senator says things like “They [DTC ads] create an artificial demand. And they drive up our nation’s overall health care costs. They needlessly and wastefully rive up your health costs.” PhRMA has steadfastly argued that there is no evidence that DTC ads drive up health care costs.

Anyway, let’s forgive Tauzin this faux pas and move on.

In a nutshell (OK, coconut shell), here’s my major gripes with the PhRMA guidelines (in no particular order of importance):

Guidelines Have No Teeth?
The principles are only “guidelines” and not stated as rules that companies will strictly abide by voluntarily. There’s lots of leeway allowed for individual companies to interpret the guidelines as they see fit. Competition will certainly mean that companies will “push the envelope” and come up with creative ways to “adhere” to the guidelines.

The guidelines do include an interesting self-regulatory mechanism — an “office of accountability” that PhRMA will establish. The general public and health care professionals can submit comments about DTC to this office and PhRMA will pass them along to member companies and to the FDA as well as issue “periodic reports” to the public regarding the comments and company responses.

It doesn’t appear, however, that the comments themselves will be made available to the public. We might need a “PhRMA Freedom of Information Act” to get that (LOL).

Of course, you can always tune in to this blog site and get my comments as well as comments form my colleagues in the PHARMA-MKTING online discussion group.

Limited to TV and Print
The guidelines only apply to TV and print advertising and not to Internet advertising. Perhaps the industry puts the Internet into a different bucket that it considers “non-advertising.”

Online marketing experts have already seized upon this and hope that restrictions on TV and print will mean more work for them. This remains to be seen.

DTC Moratorium Sidestepped
The principles sidestep the issue of a DTC moratorium and do not guarantee that physicians and public health officials will get real world experience with a drug BEFORE DTC ads appear. Principle 6 merely states “companies should spend an appropriate amount of time to educate health professionals about a new medicine or a new therapeutic indication before commencing the first DTC advertising campaign.”

This is well and good, but it does not implement anything new. Typically — and I speak from personal experience — pharmaceutical companies do a lot of physician “education” BEFORE a drug is launched. This education can begin 2 years prior to launch. During the prelaunch phase pharma companyny can only refer to the drug by its scientific name (e.g., sildenafil citrate) rather than the trade name (e.g., Viagra).

Consequently, Principle 6 will allow a pharma company to “educate health professionals” well in advance of the launch of a product and then begin DTC advertising as soon as the product is launched (when DTC advertising becomes legal).

The whole idea of a DTC moratorium is to limit DTC AFTER launch. That way physicians — educated or not — and public health agencies and FDA can get some real world experience with the drug. Prior to launch, a drug may have only been tested on a few hundred or a couple of thousand CAREFULLY CHOSEN volunteers. Only after launch, when the drug is prescribed to the general population, will the drug be used by individuals who might be prone to side effects not evident in clinical trials or not frequent enough to be picked up in clinical trials.

Tauzin, on the other hand, claims that “everything that can be known about the drug is presented to the FDA … good, bad, and ugly” and that that clinical trials reveal this information. This is patently false as the VIOXX case demonstrated.

Tauzin, however, claims that in only 3% of the cases do you learn “more about the drug” after it gets released to the general public. He clarified this by saying “only 3% of drugs approved by the FDA end up having a problem where we learn something new about them” requiring changing the ad campaign or pulling the drug form the market.

Frist, Get Your Gun
I wonder if Frist will stick to his guns and continue to demand a moratorium such as he proposed. The WSJ reported that “While Sen. Frist said he “welcomed” the industry’s effort to revamp its advertising practices, he urged individual companies to consider the two-year moratorium.” He has also said that “If these voluntary restrictions [including his moratorium idea] don’’t do the job, I believe Congress should act.” We’ll see.

Tauzin, BTW, doesn’t want to say that Congress shouldn’t act, but he repeatedly said “We’re in a free speech area” during his WSJ video interview. This, as I pointed out before, is how PhRMA and its allies will hamstring the FDA (see, for example, “WLF Watches FDA Watching Drug Ads“).

Submit DTC Ads to FDA
Principle 8 states: “Companies should submit all new DTC television advertisements to the FDA before releasing these advertisements for broadcast.”

First, I note that this principle applies only to TV ads, not print or Internet ads.

Secondly, it does NOT state that the companies should wait for FDA approval before running the ad and it does not specify any set amount of time to give the FDA for review prior to running the ad — the Q&A does suggest that companies give the FDA “a reasonable time in advance of first use to give FDA the opportunity to comment, consistent with its priorities and resources.”

IMHO, Principle 8 has a loophole big enough to drive a Mack truck through!

Treatment Options
Principle 1 says that a benefit of DTC advertising is that it “[educates] patients about treatment options” and Principle 9 states: “DTC television and print advertising should include information about the availability of other options such as diet and lifestyle changes where appropriate for the advertised condition.” Of course, the only treatment option presented in a DTC ad is the advertised drug, never OTC products or competitors’ products.

Risk Information
Principle 11 addresses the issue of communicating risk in TV DTC ads: “Specifically, risks and safety information in DTC television advertising should be presented in clear, understandable language, without distraction from the content, and in a manner that supports the responsible dialogue between patients and health care professionals.”

Tauzin has said “You will see a change in the [current] ads.” Instead of “mumbling” side effects at the end of ads, says Tauzin, “the [side] effects are going to be talked about in the ad.” Hopefully, the type of ad pioneered recently by J&J will act as a model (see “DTC Straight Talk“).