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Pharma Marketers Ask FDA For Online Ads - Tweeting Side Effects In 140 Characters Or Less?

In 1997, the makers of top-selling pharmaceuticals won the right to start putting ads on television, investing more than $4 billionin 2009 alone spent on subtle slogans about impotency (or "male enhancement"), new breakthrough pills that can grow eyelashes for the ladies, memory-enhancing Alzheimer's medication and the revelation that depression hurts and a popular anti-depressant medicine can help.

But there was a caveat to pharmaceutical advertising on television. Side effects of all medicines, as mandated the Food and Drug Administration (FDA), must be disclosed in their entirety. That's why when these ads air, we hear a long and uncomfortable dialogue from a fictitious doctor telling his actress patient about all the terrible things that can happen if she pops whatever pill they're peddling.

With the growth of the Internet as a social marketing and mainstream advertising machine, the drug companies want in. But the side effect of the FDA approving the drug maker's request is, well, the side effects. Direct-to-patient marketing of prescription drugs is driving the pharma machine now. Many patients will inquire about, or even demand to receive, a medication they have seen advertised on television. In the United States, recent years have seen an increase in mass media advertisements for pharmaceuticals.

Expenditures on direct-to-consumer ads have more than quintupled in the last seven years since the FDA changed the guidelines, from $700 million in 1997 to more than $4.2 billion in 2005, according to the United States GAO (Government Accountability Office).

Industry analysts say drug companies and health insurance companies have largely steered clear of the Web for fear of running afoul of FDA regulators, who have not defined the rules of operating online.

In a public statement announcing that it was taking up the issue, the FDA acknowledged that "emerging technologies may require the agency to provide additional guidance." But some industry experts worry the FDA's rule development process - which often takes years - cannot keep pace with online innovation.

"What's happening is these new media are emerging at an increasingly rapid rate, and are being regulated by an agency that moves very slowly," said attorney Mark Senak, who advises drug companies as a consultant for a major advertising firm. "In essence, you have a regulatory communication crisis developing." When drug companies have tried to adapt such ads to the abbreviated language of major search engines, they've run into trouble. The FDA recently sent warning letters to a dozen other drugmakers for search engine ads that did not mention drug risks.

As they say, stay tuned...Er, tweeted. To most people, health insurance is a card with numbers you take to the doctor's office and a little booklet of paper that lives in your filing cabinet, closet or dusty corner of your home. To McKinley, health insurance and the historical reforms that go along with the inequality of healthcare in America are topics of healthy discussion, worthy of further study and catalysts for education and action. McKinley moved to South Florida after directing corporate communications and marketing strategy for several FORTUNE 500 companies and public relations agencies. A founder of Communicatia, Ink (an independent communications company he founded while working as a business reporter and newscaster in Nashville), McKinely is an emerging subject matter expert on health insurance and regulatory issues

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