What Moratorium? - Pharmaceutical Executive


What Moratorium?
Most physicians agree that direct-to-consumer advertisements should be put on hold, but few are screaming for change. Why?

Pharmaceutical Executive

Did you have any physicians tell you that they didn't know about a drug until a patient brought it up?

I'm sure it does happen. And, in fact, likely one of the reasons there's usually a pause once a drug is approved and before a marketer will begin advertising is because the drugmaker wants to give the physicians time to become familiar with it and to let the reps talk to the physicians.

I think the physician would be more receptive to a patient coming in and making requests if he's at least beginning to become more familiar with the new drug than he would finding out about it almost at the same time as the patient. I think the physician's probably a little bit put out by that.

What was the most surprising response you received?

The wariness of physicians about what's going on at the government level regarding FDA and revitalization. The fact that hardly any of them were aware of it. I thought we would have a much higher awareness and a lot more point of view being stated by the AMA. We're not hearing from them. So it seems to me that these may be issues more for pharma companies and for pro or con advocates of DTC.

If FDA has approved a drug and the advertiser is not misrepresenting what the drug does, shouldn't the company have the opportunity to say whatever it wants to say about its drug?

As long as the statements in the advertising are not misleading or clearly untruthful, then yes. I think that has been the way that it's been in this country for the last 10 to 12 years. DTC advertising is something that is felt to be helpful to the consumer.

Do you think DTC advertising keeps consumers from fully understanding the risks of the drug?

If someone wants to bury something that's negative, yes, they can do that. I'm not saying that advertisers are doing that in the pharmaceutical industry, but I'm saying clearly that can happen. So I think it behooves everyone to be sure that they are being open about that. The pharma industry has been very careful about being open and not being accused of hiding because there's absolutely no benefit to the industry to be accused—or to be doing that intentionally. It absolutely will backfire on them.

The PDUFA IV legislation passed in the fall includes a provision that FDA can levy hefty fines against companies that do falsely advertise.

Under the system, if FDA determines an ad to be false or misleading and if the company chooses to challenge the decision, the matter goes to an administrative law judge. It's $250,000 for each day a defending ad ran after notification.

If the Vioxx events hadn't happened, do you think there would've been this much of a call for a moratorium?

The Vioxx situation had a lot to do with raising everyone's yellow flag. It made people think, "Maybe we need to step back a little bit here and take a harder look at what's going on." Not to say that we're arbitrarily throwing out the baby with the bathwater, but are we giving it a hard look? Are we doing the right thing? Or do we need to be modifying what we do? And I think the answer is that there's a need to modify the current rules.

According to the survey, doctors and consumers are calling for some kind of moratorium, but it doesn't look like industry's heading that way. Do you see any reasons why?

In the survey, under the level of agreement with a DTC ad moratorium, half of the people interviewed said that they really had no opinion—"I haven't decided whether I'm in favor of the moratorium or not." Though there was a large minority who said they did, in fact, favor a moratorium. So the question is, if we have something like 44 percent of the people saying they do agree with a moratorium of some length, why didn't it happen? I'm not seeing groups and advocates screaming and yelling for such change.


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