Archive for December 29th, 2008

DTC Europe-Ban Loosened

December 29th, 2008 | No Comments | Source: Wall Street Journal

As Big Pharma celebrates the tenth anniversary of the direct to consumer advertising bonanza in the US, there may be more good news for the industry coming out of Europe.

The European Commission had steadfastly prohibited the practice on the continent, but last week its officials proposed legislation allowing drug companies to provide consumers “objective and non-promotional information” about their drugs in magazines and on Web sites.

freeourmoney 203x300 DTC Europe Ban LoosenedThe legislation would allow drug companies to provide “medicinal, product-related information” that “does not go beyond the elements” of the inside drug packaging.

The information could cover for example side effects, prices or anything that “presents the medicinal product in the context of the condition to be prevented or treated,” according to Commission documents reviewed by the Wall Street Journal.

No one’s holding their breath of course because this is Europe: the legislation must be approved by the European Parliament and the Council of Ministers, and that could take years.

The Commission, which is the Executive arm of the European Union, believes the current ban is woefully out of date in an era when consumers are heavily involved in their care and routinely seek out medical information on the Web.

Speaking for the Commission, Gunter Verheugen VP of enterprise and industry emphasized the EU is not relaxing its ban on drug advertising. “There will be strict rules regarding content and these will be tightly monitored,” he told the Journal.

European consumer protection groups do not support the Commission’s decision, because they don’t believe Big Pharma can be trusted.

“It’s just a disguised way of giving pharmaceutical companies greater flexibility to provide the information they want on prescription medicines,” Monique Goyens told the Journal.

It’s safe to say that Goyens, director of the European Consumers’ Organization, would not encounter many in the US who disagree with that.

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DTC North America-Bonanza

December 29th, 2008 | 1 Comment | Source: Wall Street Journal, WSJ Health Blog

In the decade since the FDA began permitting Big Pharma to market drugs directly to consumers, the ads have become ubiquitous on TV and radio and in print media.

The industry spends $5 billion per year on DTC and no one argues the ads move mountains. For example, ads for the highly effective cholesterol-lowering statins have increased their utilization and almost certainly saved lives as a result.

geniesoutofthebottle 225x300 DTC North America BonanzaBut it’s galled more than a few folks that DTC ads have been equally effective promoting lifestyle drugs that line Big Pharma’s pockets without doing much to improve overall population health.

Rep. Bart Stupak (D-Mich.) for example, never did warm to the DTC concept. In May, he called out Pfizer for Lipitor ads featuring Robert Jarvik, the well-known inventor of the artificial heart because Jarvik is not a practicing physician.

So Big Pharma knew what to expect from Stupak when PhRMA, its trade group announced last week it was tightening its own guidelines governing DTC practices.

The new “voluntary guiding principles” include halting the practice of using actors to role-play physicians on DTC ads, requiring that celebrities cease claiming they use drugs unless they actually do, and ceasing the promotion of drugs for indications not approved by the FDA.

The guidelines also limit ads with adult-oriented DTC content (that would be Viagra and congeners) to programs that normally draw adult audiences.

Stupak offered lukewarm praise and quickly added that the guidelines don’t go far enough.

He wants Big Pharma to wait 2 years after drugs are marketed before releasing ads DTC to assure all drug effects are fully understood.  He also wants the FDA’s toll-free number to appear on DTC ads to facilitate reporting of side effects.

Industry spokespeople indicated they’d be happy to review the issue in a few years if critics remained unsatisfied. There’s no chance the issue remains quiet that long.

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