DTC reform on the horizon?
Prescription drug marketing restrictions hopelessly out-dated

When Pfizer Canada debuted new ads earlier this week to promote its erectile dysfunction medication Viagra, -- which are to be run during NHL hockey playoff telecasts - something important was missing: the product name.

That's because under the complex regulatory regime governing direct-to-consumer pharmaceutical advertising of prescription drugs in Canada, companies are allowed to use marketing media to educate consumers, and they are allowed to mention the brands that they sell, but they can't do both in the same ad.

Under the current regime, Canadians must rely on their physicians to provide them with appropriate treatment information for their health conditions, a system largely supported by the nation's doctors.

"We're opposed to direct-to-consumer advertising," said Dr. Peter Barrett, president of the Canadian Medical Association. "The information that consumers get should be unbiased, and the best person to deliver unbiased medical information is the physician."

For highly publicized products like Viagra, the direct-to-consumer advertising restrictions do not present too much of a problem. Pfizer's new Viagra ad talks about the public's reluctance to discuss erectile dysfunction, and refers people to a 1-800 number and Web-site where they can get more information.

Pfizer managers know that since Viagra is the only oral treatment currently available that deals with erectile dysfunction, those who watch the ads, and who end up asking their doctors about the problem, will in the end be prescribed Viagra, not a competitor's product.

However not all pharmaceutical companies are in as comfortable a position. Take Wyeth-Ayerst Canada Inc., which last year tested the DTC advertising limits in its promotion of the birth control medication Alesse.

When marketing Alesse, Wyeth-Ayerst managers were faced with a problem. If they promoted the importance of birth control, they would not be allowed to use their company or product name in the same ads. So a campaign centered on birth control would risk driving consumers to competitor's birth control pills, or even worse - to using condoms.

Their solution was running two ads, one shortly after the other. The first talked about the importance of birth control. The second featured Alesse, with no mention of what the product does.

According to Ray Chepesiuk, president of the Pharmaceutical Advertising Advisory Board, which monitors prescription drug advertising to physicians, the Alesse campaign was shrewdly designed.

"You had two ads, using the same actors, the same music, with the same look and feel, thereby linking branded and unbranded messages," said Chepesiuk. "Taken apart, neither was prohibited. Although the inference was obvious: one ad talks about birth control, and in the next, you see a box of Alesse."

In response to the Alesse campaign, Health Canada issued a policy statement stating that running two separate ads, that taken together violate the regulations, is prohibited.

But there are increasing signs that the federal government's ability to maintain the DTC ban is eroding. American pharmaceutical companies advertise prescription drugs directly to the consumer, much of which spills across the border.

This creates a serious problem since many products licensed in the U.S. - such as Viagra, was - are not immediately approved for distribution in Canada. The result is Canadian patients asking their doctors about products that they are not allowed to prescribe.

To make matters worse, the increasing strain on Canada's medical system is leaving physicians less time to spend with patients. This means that patients must assume increasing responsibility for their own well-being. That implies getting access to new information. Information the pharmaceutical industry believes that it can help provide.

Beyond the spillover DTC advertising from the U.S., some Canadian companies are flaunting existing limits so blatantly, it seems they are daring regulators to take action.

For example Glaxo Wellcome - which markets Zyban, a pill to help stop smoking --ran a series of public service announcements about quitting the habit, which were timed to coincide with the year-end, when people are most likely to make resolutions. At the end of the ads, there was a statement indicating that Zyban was the sponsor -almost certainly violating the existing regulations.

However there are signs that Health Canada is looking into the many problems with the current restrictions. Earlier this year, the department initiated a survey of the major stakeholders in the pharmaceutical marketing process. This should lead to a new policy paper on DTC reform, which could become part of an overhaul of the Food and Drug Act.

Of course there have been noises about impending DTC reforms in the past, which have led to nothing. But the increasing gaps in the current legislation, especially the latent questions about its constitutionality, in the wake of the Supreme Court's decision allowing some tobacco advertising, are providing additional impetus for action.


Photo caption: Direct to consumer advertising of prescription drugs - in which a product name is linked with a health condition, for example this Viagra ad featuring Bob Dole --is permitted in the U.S., but not in Canada.


E-mail can be sent to Diekmeyer at: peter@peterdiekmeyer.com


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