F.D.A. Rules on Drug Ads Sow Confusion as Applied to Web

WHEN the Food and Drug Administration sent letters to 14 major pharmaceutical companies late last month, the warning was strong. The companies’ search advertisements — the short text ads that run beside Google results — had to start including risk information about each drug or else be rewritten or removed.

Just how the companies were supposed to comply was not so clear. In the 95 characters that Google allowed for search ads, there was no way to include all the required information, the companies argued.

Now, as the companies change their search ads to comply with the letters, industry executives say the solution is worse than the problem: their ads are even more confusing and misleading now, they say. And they worry that regulators will enforce standards that were created for magazines and television, rather than making new rules that acknowledge how Internet ads have evolved.

The letters were sent to almost all of the major pharmaceutical companies, including GlaxoSmithKline, Pfizer, Merck and Eli Lilly. The letters said ads for widely prescribed drugs, including Celebrex, Propecia and Yaz, did not include the paragraphs of precautions the agency required.

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Campaign on Childhood Mental Illness Succeeds at Being Provocative

We have your son. We will make sure he will no longer be able to care for himself or interact socially as long as he lives.

— Autism

SO reads one of the six “ransom notes” that make up a provocative public service campaign introduced this week by the New York University Child Study Center to raise awareness of what Dr. Harold S. Koplewicz, the center’s founder and director, called “the silent public health epidemic of children’s mental illness.”

Produced pro bono by BBDO, an Omnicom agency that worked on two previous campaigns for the Child Study Center, the campaign features scrawled and typed communiqués as well as simulations of classic ransom notes, composed of words clipped from a newspaper.

In addition to autism, there are ominous threats concerning depression, obsessive-compulsive disorder, attention-deficit hyperactivity disorder, Asperger’s syndrome and bulimia. The campaign’s overarching theme is that 12 million children “are held hostage by a psychiatric disorder.”

The public service announcements began running this week in New York magazine and Newsweek as well as on kiosks, billboards and construction sites around New York City.

“Children’s mental disorders are truly the last great public health problem that has been left unaddressed,” said Dr. Koplewicz, adding: “It’s like with AIDS. Everyone needs to be concerned and informed.”

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The Drug Advertising Debate

Some members of Congress want to limit Big Pharma's ability to promote products directly to consumers. But the roadblocks are high.

If Representative Henry Waxman (D-Calif.) had his way, the little butterfly used to advertise the insomnia remedy Lunesta might not be allowed to flutter all over our TV screens, as it has incessantly since the drug was approved in late 2004. Waxman believes the U.S. Food & Drug Administration should be able to forbid companies from advertising directly to consumers until new drugs have been on the market for at least three years. He tried to mandate such a restriction by attaching it to a drug-safety bill. But on July 11 he came up short. After a debate centered on drug companies' right to free speech, the bill passed with virtually all restrictions on drug advertising stripped out.

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Pharma ads could come to Canada

Now the Supreme Court of Canada has upheld tobacco advertising restrictions, the next giant court battle -- over prescription drug marketing -- is around the corner.

Cross-examination of expert witnesses is set to begin this fall in a constitutional challenge that pits CanWest MediaWorks Inc. against a coalition of health, consumer and union groups.

CanWest, which owns a string of newspapers, as well as Global Television, wants the ban on so-called direct-to-consumer advertising of prescription drugs removed, arguing it's a violation of freedom of expression.

READ MORE @ EDMONTON SUN