That is my takeaway from last week’s DTC National in Washington. I saw no indication that DTC is fading away as an accepted technique for pharmaceutical marketing. Of course much of the conference discussion was on the impact of Obama and his appointees on the drug industry. New FDA leaders raise the likelihood of increased regulation but no speaker predicted disaster in terms of bans or restrictions that would make DTC impossible to execute. It is probable new risk regulations or guidances will come out late in 2009 that may add requirements for information. That could make a 60 second ad harder to do but it is not going to be so onerous as to end mass branded television.

ROI seems strong averaging over 2 for the top 25 brands as presented by IMS. Although spending is likely to continue to drop in 2009 attendees seemed optimistic it would stabilize in 2010. There were the usual debates over the media mix. The new media advocates say drug marketers are too slow to adopt modern technology that can personalize communications. The mass media broadcast and print advocates say their media delivers scale and good ROI, and given the age of the target group, still deserves the majority of spending. My take is that drug marketers are open to greater use of modern technology but will move deliberately given regulatory uncertainty.

The recent warning letters over word search raised the issue of FDA not adapting old regulations for new media. The FDA is following the regulations written decades ago before anyone anticipated the explosion of technology. In questions to the FDA raised at the meeting, attendees seemed frustrated over FDA’s lack of customizing the regulations for the medium. I sense this will change over time but for now the FDA will not bend on following the regulations as written. Congress is looking for FDA to clamp down on enforcement and this is not an ideal time for FDA to bend the rules.

I also became enamored with the instant feedback of Twitter. My 23 year old daughter, attending the conference to meet potential employers with her new Masters in Advertising, called my attention to feedback on the conference being twittered around. This twittering was between attendees as well as attendees to colleagues back at their companies. Any speaker comment or attendee question was instantly dissected, criticized and shot across the electronic highway.

What I came away with most was the quality of the people working in DTC. Despite the image of pharma marketers as being profit mad corporate tools, nothing could be further from the truth. I never heard any cynical comments publicly or privately which in any way reflected an anti-consumer tone. These people are dedicated to what they do and care about improving health. They feel more information is better and are proud of communicating their point of view through DTC. It would help if critics softened the populist rhetoric and dealt with how to make DTC better. I know the people doing the DTC are willing to listen and improve it.

So, I am proud to be part of getting 500 plus DTC marketers together every spring.  I hope to keep doing it as long as people are willing to attend. Thanks to all who attended and all those unable to be there but who will learn from the attendees.

The FDA took widespread action against drug companies who have used the popular ad words on Google. FDA rules require that any mention of a drug name with its indication requires full fair balance. Drug companies have been short cutting that rule by assuming the one click away process for ad words was sufficient. For example consumers who type in a disease would see a two line side ad that gave the drug name that treats the disease with a one line description of its effectiveness. If they clicked they would go to the company site loaded with fair balance.

For example, type in birth control and get an ad that says how effective a named medication is for preventing pregnancy. That is illegal under current promotional regulations. Drug companies have been using these ads for a long time and FDA has finally ruled that short ads without fair balance are unacceptable, even with an easy click to fair balance.

On April 3, 14 letters referencing 48 drugs were sent out to many major drug companies telling them to cease and desist from this practice. Obviously, this makes ad words harder to execute. Drug companies will now have to make no claims about a drug or show any indication of what it is for.

Our editor of DTC Perspectives, Mark Tosh, got a response to some follow-up questions on the letters from FDA. They say drug companies can either do reminder ads with nothing mentioned except the drug name or use disease awareness ads. The FDA said that space limitation is no excuse for not including fair balance. They also said that many drug ads had followed the rules when using ad words.

I do not believe drug companies are going to lose much by dropping the indication or a brief claim line. If a consumer enters a disease name and a reminder ad appears with just a brand name, the consumer will still understand the brand is a likely treatment. The letters, however, were a clear warning that a new era is here with increased vigilance from FDA. I doubt drug companies will drop the ad word use and instead will comply using more reminder ads. Perhaps the loss of the indication tag line makes for fewer click troughs but I doubt a significant drop off. It will make an interesting analysis from Google.

There are some critics who hope serious restrictions will be placed on DTC advertising in 2009. These anti-DTC folks include some politicians, consumer advocates, medical professionals, and insurance plans. My guess is they will be disappointed with the slow pace of increased regulation.

Our Congress will take up health care later this year. Extending health coverage and cost containment will be the big issues. We have an enormous cost bubble which will burst unless serious action is taken within the next decade. Drug costs are part of the issue, but given slower rates of drug inflation versus other health costs, it is not the top priority.

We will see action taken short term to put more pressure on drug prices. That includes re-importation and Medicare price negotiation. That should result in drug prices being held down significantly. The DTC specific issues are also important to Congress. Clearly they would prefer it could be legislated away because they believe it causes improper branded drug use and thus raises costs. They also say safety is an issue and want drug advertising delayed for new products until a full in-market safety profile is known. They also know they cannot just ban legal commercial speech so the ban is off the table. The best they can do is place a moratorium on new drug ads and make television ads harder to execute.

If the pace of DDMAC research on DTC is any indication we can expect a slow and measured consideration of change. Their web site lists the upcoming DTC study research dates and it appears much of it will not be out until 2012. Their small staff and budget prevents them from acting faster. Congress blusters a lot about action but then provides miniscule resources to get things done.

Obama says health care action is too important to wait. He is right but the health care issues make banking problems seem simple. The massive administrative bureaucracies both in Medicare and the private insurance sector will take years to change. All the good intent in the world will not make major change happen soon. I would say DTC regulation is way down on the list of changes needed.

What then can we expect for DTC? Probably not much new DTC regulatory action will happen in 2009 or 2010. There is no major problem with DTC being an imminent threat to safety or raising drug cost. FDA will be more active in issuing warning letters and demanding corrective ads.  That should satisfy the increasingly regulatory minded Congress for the next few years.