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FDA to assess drugmakers’ websites

Thursday, April 28, 2011

U.S. drug regulators will scrutinize consumer reactions to websites for prescription drugs in an attempt to research how to apply advertising rules to social media, according to a Bloomberg report. 

The FDA may issue rules this year outlining how drugmakers can post more tweets and online videos without violating marketing rules written for print, radio and television. Prescription drug ads pushing a product’s benefits must also provide information about risks.  Slow sales and high costs are forcing manufacturers to find cheaper ways to advertise, such as using the social media sites Twitter and Facebook.

The FDA proposed the agency conduct three studies in which participants would view a website advertising a fictitious drug and then answer questions regarding information about a drug.  The studies will examine whether personal testimonial videos posted on a site influenced consumer perceptions of a product. The FDA will also investigate whether the participants understand possible side effects of the drug after reading about risk information on a website.

“Currently, there are a number of questions surrounding how to achieve ‘fair balance’” in online direct-to-consumer promotions, the agency said. The proposed web-advertising studies are “relevant to current policy questions and debate and will complement qualitative research we plan to conduct on issues surrounding social media.”

The FDA reported that “risk information is often presented less prominently and in fewer locations on the website” as opposed to the information about drug benefits. Moreover, the agency indicated that side effects and risks are “often incomplete and written at very high literacy levels.”

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