Yesterday I had the good fortune to participate on a panel staged at the National DTC Perspectives Conference held here in Washington. The conference was impressive not only because of the size and scope of the turnout – hundreds of people representing a good span of stakeholders – but also because of the quality of the speakers (other than myself, of course), which included such notables as Bill Novelli, CEO emeritus of the AARP.
One of the presentations, given by Mike McCaughan of the RPM Report (who also tweets, and I recommend you follow) provided a very nice analysis of the current regulatory environment and the political winds that are re-shaping it. If I can get acess to his slides, I'll provide a summary in a future posting.
Naturally, a great deal of the focus of the conference is what the future of DTC looks like in this environment and in particular, whether there will be a moratorium on DTC advertising. Yesterday, I provided some insight in writing about the appointment of David Dorsey from Senator Kennedy's office who will be a senior counselor to Dr. Joshua Sharfstein, currently Acting Commissioner at FDA and soon to be Deputy Commissioner after the confirmation of Dr. Margaret Hamburg as commissioner. He is no fan of DTC.
What about Drs. Sharfstein and Hamburg? They come to the FDA without any connection to industry and the role of drug marketing is probably not their concern. In fact, during his career, Dr. Sharfstein was active in the realm of OTC marketing, taking a position on the marketing of cold remedies for children that was both decisive and firm. However, while marketing may not be their focus, public health is and they both, undoubtedly, understand the role of public health campaigns to change behaviors with respect to health.
To my mind, then, that means that the more that DTC embraces public health education (and by this, I don't mean about conditions that no one has ever heard about before) OVER pure drug marketing, the better off advocates will be. I think in the future, to the extent that they exist at all, drug ads will come more to look like the lengthy but informative Celebrex ads that are currently appearing on television which go into a great deal of detail to inform about risks.
With respect to the point about whether such ads exist in the future, I think there is a good chance that a moratorium on advertising for a period of 3 years will be introduced. Many in industry peg their hat on the argument that industry already has a moratorium that is unspoken by virtue of the fact that most ad campaigns don't begin until a drug has been on the market for six months. Frankly, that dog just won't hunt. Many others are of the mind that the First Amendment will protect the free speech of DTC and there is much more merit to that. But First Amendment rights can take many years to be determined, which would mean that in the short term, legislators could easily short-circuit DTC advertising, or at least by proposing such a moratorium, change the shape of it significantly.
There are two more days of the conference left.
Mark
What is the rationale for three years over the prior talked about two years post launch for start of DTC advertising?
As you can imagine, the current length of the celebrex tv ads would cut out many of the smaller pharma brands from participating with dtc…only the few very big brands and categories would be able to participate with advertising of this length given the typical ROI payouts.
Ellen – Bearing in mind, I am not a proponent of a 3 year moratorium, but here is the reasoning I suspect exists for that longer term. First, many of the high profile problems with some of the classes and drugs that experienced problems after being out on the market (COX-2s, Vytorin, e.g.) came to light after longer than only 2 years, allowing them to be marketed aggressively to patients before enough study was able to make links to particular outcomes. Second, there is a strong belief, correct or not, on the part of many that the costs of marketing contribute substantially to the cost of a drug on the market. Limit the time of marketing and you limit the expense associated with marketing. I don’t think proponents of reformed DTC marketing would be at all concerned that ads that are more focused on risk and require longer periods of time to explain the nature of the risks and benefits might mean that fewer drugs can afford such marketing.