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FDA to Revisit Direct-to-Consumer Drug Marketing

Panexa. Ask Your Doctor For A Reason To Take It [1]

Panexa (Acidachrome Promanganate). No matter what you do or where you go, you’re always going to be yourself. And Panexa knows this. Your lifestyle is one of the biggest factors in choosing how to live. Why trust it to anything less? Panexa is proven to provide more medication to those who take it than any other comparable solution. Panexa is the right choice, the safe choice. The only choice.

While the Panexa web advertising includes all the relevant drug interaction details, including safety information for squirrels, this parody doesn’t seem too far off the mark in today’s direct-to-consumer drug advertising.

Now, the U.S. Food and Drug Administration [2] is weighing whether it should revisit its policy on direct-to-consumer ads and will take comments on the issue through the end of February. In 1997, it relaxed restrictions on broadcast and print ads, which led to a marketing explosion. Pharmaceutical companies now spend an estimated $4 billion a year promoting products this way on TV and radio, in print, and on the Internet.

One driver in this is the earlier recall of the arthritis drug Vioxx because of dangerous cardiac side effects – a medication heavily promoted directly to consumers. Merck & Co. [3] spent up to $160 million annually on Vioxx ads, and sales of the drug skyrocketed, often to people who may not have needed to take it.

In August, the Pharmaceutical Research and Manufacturers of America (PhRMA) [4] said its members would voluntarily delay broadcast ads for new products for six months, among other new restrictions. The policy does not apply to print ads. Earlier in the year, Senate Majority Leader Bill Frist proposed a moratorium on direct-to-consumer advertising – a move estimated could cost the industry as much as $10 billion if it ever comes to fruition. Many believe drug makers have too much influence over physicians and patients. While direct-to-consumer advertising can educate patients without inflating need, evidence suggests that direct-to-consumer advertising has unwittingly led to inappropriate prescribing, which can compromise patient safety and care.

Representatives of Consumers Union and the National Consumers League said all ads should be cleared by the FDA before they are broadcast or printed. Currently, ads only have to be submitted sometime during a campaign. In 2004, 586 TV ads and 52,848 other types of promotions were submitted to the agency. Consumer groups also called for more information on both risks and benefits of drugs that are marketed this way.

But drug makers defended the ads, saying they have motivated people to seek a doctor’s help. J. Patrick Kelly, president of Pfizer U.S. Pharmaceuticals, said that 65 million people have talked to a doctor as a result of ads, and that 29 million had discussed a condition for the first time. Pfizer will wait six months before advertising a new drug, and will be running more consumer-friendly descriptions of drug risks in print ads, Kelly added.

AstraZeneca, the company responsible for “the purple pill,” said that all such ads should be submitted to the FDA for review before they run.

But just remember: There are no known medical circumstances (based on extensive internal testing) in which PANEXA cannot be used!

More here [5].