Drug ad effects on people need more study: FDA

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By Susan Heavey
Thu May 15, 6:15 PM ET

ROCKVILLE, Maryland (Reuters) – Ads for prescription drugs need to be clear and direct and government needs to study the effects these ads have on consumer behavior, particularly among the elderly and minorities, a U.S. Food and Drug Administration panel of outside experts said on Thursday.

“It’s about how it’s understood and how it’s used. It’s impact,” panel member Ellen Peters, a researcher from Oregon, said.

Data shows that advertisements for drugs prompt people to see their doctors, but it is not clear if consumers understand potential benefits and risks of the drugs being promoted by pharmaceutical companies.

Panelist Michael Goldstein, associate director at the nonprofit group the Institute for Healthcare Communication, told the FDA that it should find ways to tackle “the woefully inadequate evidence we have about what … direct-to-consumer advertising is actually doing.”

The FDA is seeking input from advisers as it prepares to report to Congress about how ads impact consumers, especially older people and children, blacks, Hispanics and other minorities.

Legislation that took effect in March allows the FDA to ask to review ads before the public sees them and to impose fines if an ad is misleading. It also empowered the FDA to study the effect of such advertising on the public.

Last year, 68,000 promotions including commercials and print ads, magnets and pens, were submitted to the FDA, according to Kristin Davis, deputy director for the FDA’s Division of Drug Marketing, Advertising and Communications.

“In an ideal world we’d look at everything,” she said, noting that staff levels make that impossible. Instead, the agency tries to target promotions, including ads, that are likely to have the biggest impact.

Drug companies spent nearly $29.9 billion in 2005 on advertising, free samples, and sales staff to promote brand name products, according to a study funded by the National Institutes of Health published last year.

More than $4 billion of that was spent on consumer ads compared to $429 million for ads directed at doctors.

U.S. lawmakers are investigating whether drug companies use marketing tricks to mislead consumers, especially through television commercials. Researchers have said drug companies use gimmicks such as small type, fast speech and flashy graphics to emphasize benefits and downplay risks.

Rep. Bart Stupak, the Michigan Democrat overseeing the House Energy and Commerce subcommittee investigation, wants drug companies to make commercials that are more clear or face tougher regulations and possible restrictions.

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