Henry Waxman is not making a secret of his desires to restrict DTC. Long a critic, Mr. Waxman will now have a friendly Congress and White House behind him. In a speech to the Prescription Project on 12/8, a group looking to restrict marketing to physicians and consumers, the Congressman told the attendees he wants to restrict DTC for new some new products for up to two years.

The idea of a moratorium on advertising for new products has been discussed for several years. The drug companies and advertisers successfully prevented it from happening in the current Congress. The new Congress will have much stronger majorities for anti-DTC forces and Waxman will have support to pass something more restrictive. Currently a few drug companies have agreed on voluntary delays in DTC up to one year but Congress wants more.

The moratorium Waxman proposes is not automatic nor will it apply to all new drugs. That power will be left to FDA to use if needed. I expect that any new class of drug will fall into the mandatory moratorium category. I doubt it will be used for new versions of existing classes of drugs. Realistically then, we can expect a moratorium to be used infrequently, given the rarity of new drug classes.     

Of course, the advertising industry will fight tooth and nail to prevent any imposed moratorium policy instead wanting to keep it voluntary. The ad industry is afraid even a rarely used moratorium could quickly become a widely used one and for more than two years. Ad lobbyists will use prior restraint of commercial speech as the defense. They may win in court if it goes that far given precedent on commercial speech. My guess is the drug companies will agree to extend the moratorium period for new drug class advertising long enough to satisfy the FDA and Congress. Thus, it may be a power never imposed on the drug companies even if given to the FDA by Congress. I am sure drug companies will be delaying DTC longer so as not to anger a more powerful FDA. Drug companies know that FDA can delay new drug approval and will not let the use of DTC be a barrier to that approval.

I have never been opposed to a reasonable moratorium period. Critics have a legitimate point that many side effects do not appear in small clinical studies and take a year or more to be seen in actual use post launch. A moratorium would theoretically slow both consumer awareness and demand allowing physicians more time to gradually ramp up use. On the other hand, that also means a breakthrough drug would be kept out of public knowledge longer. The issue is whether safety conservatism trumps faster adoption of a novel drug. It is not so easy to assume that delays in consumer awareness really are in the public interest. It is true that some lives may be saved by allowing a longer time for discovering side effects. Lives may be lost, however, by delaying a fast roll-out of a good drug.

I hope whatever Mr. Waxman does recognizes the consequences of insisting on moratorium periods of two years. The trade-off between safety and better efficacy are not easy to determine. What is needed is pragmatism between critics and drug companies. So far Mr. Obama seems very pragmatic, but I fear some in Congress have been salivating at the prospect of sticking it to drug companies. I hope Mr. Waxman can see both sides of the arguments and the unintended consequences of holding up consumer information for long periods.

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.

In these troubled times for pharmaceutical companies, some CEO’s are becoming publicly more critical of industry practices. One is Roche CEO, William Burns. At a Financial Times conference in London on 12/2, Reuters reported Mr. Burns said DTC was the “single worst decision for the industry.” He said this because he apparently believes DTC hurts the credibility of industry claims that it is spending more on R&D than promotion. 

Mr. Burns believes that the days of marketing me-too drugs are over. He said “the marginally different and market it like hell model is over.” I do not have access to his entire speech or context but I will comment on what I have seen in the Reuters report.

Mr. Burns is probably correct that DTC has contributed to industry image problems. There is no doubt that DTC has provided very visible fodder for political criticism. That being said, DTC has done a lot of good in opening up discussions on disease categories and previously undiagnosed conditions. Blaming DTC for the drug industry image problems, however, is just unfair. The drug industry had been criticized extensively pre-DTC for its pricing practices. The single worst decision of the drug companies was not DTC, but being slow to develop widely available price subsidy programs that would improve access at lower cost. For years the drug industry hoped the price issue could be avoided or deflected. DTC did not cause that head in the sand behavior.  Criticisms of drug industry patent extension practices, safety monitoring, clinical study disclosures, off label claims and cozy relationships with opinion leaders have nothing to do with DTC.

Mr. Burns says the me-too marketing machine days are over. He is probably right on this point. Consumers are being asked by payers to contribute more for these brands and therefore patients will demand justification from their physicians as to why they should use them. Mr. Burns should acknowledge, however, that me-toos create price competition and provide incentives for continual product improvements. Drug companies use me-toos to generate cash that allow for innovative new drugs.

Now let me comment on the reality of DTC spending. The real DTC spending is about 60% of reported spending because DTC is reported at retail pricing not what drug companies really pay media outlets. Therefore it is about $3, not $5 billion. That is about 1% of U.S. drug sales and about 10% of total marketing spending. DTC does not raise consumer prices because it is such a relatively low cost to drug companies. R&D spending is much higher than DTC spending. Mr. Burns should be commenting on the other elements of drug promotion which make up 90% of marketing spending. It is detailing, sampling, medical meetings, and physician ads that make up the bulk of brand budgets. These tactics are criticized by politicians at least as often as DTC because of the opaque nature of these activities compared to transparent TV and print ads.

I doubt Henry Waxman would be any less critical of Roche or the other drug companies even if DTC never existed. The core issues remain high prices and drug safety, and neither was caused by DTC. It is true that DTC may be contributing to the critics’ anger, but it is a little much to use it as a main reason for drug industry image issues.