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FDA Considers Drug Promotion Requirements for Broadband Age

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WASHINGTON, November 15, 2009 - The Food and Drug Administration last week considered how regulated medical products such as prescription drugs for humans or animals should be promoted on the Internet and through the use of social media tools.

“The FDA has been widely criticized for not providing guidance for drug companies eager to promote their products on the internet,” according to Kate Greenwood, a faculty member of Seton Hall University School of Law’s Center for Health & Pharmaceutical Law & Policy. “In recent months, the FDA has indicated that it is open to providing internet-specific marketing guidance,” she said.

The FDA held a two-day public hearing to gather feedback from interested parties in order to “help guide FDA in making policy decisions on the promotion of human and animal prescription drugs and biologics and medical devices using the Internet and social media tools.” In April the FDA sent a number of warning letters to companies with sponsored ad links on Google, telling them their ads were in violation of the law and asking that they be taken down.

During the meeting, Google proposed a new ad design for FDA-related approved that would include an extra line of text stating important risks and a link to more information. According to a blog entry from the search giant, Google Managing Policy Counsel Pablo Chavez wrote that the company “share[s] their goal of better understanding how to promote medical products online in a non-misleading and balanced manner.” He said Google’s ad pitch would help set “a clear standard for advertisers.”

“The Internet, and how people use it, has changed a lot since the FDA last examined access to online health information in 1996. On Google alone, we've seen health condition searches increase several times over. What this tells us is that people find health related searches - and the ads they return – useful,” stated Chavez.

The Pharmaceutical Research and Manufacturers of America suggested the FDA adopt a logo to help guide patients and healthcare providers to FDA-regulated information about medical products.

“The FDA could help patients and could better serve the public health by following this week’s public dialogue with guidance that outlines clear standards to help patients access truthful, reliable information on the Internet,” said PhRMA Senior Vice President Ken Johnson.

“Just as FDA and the White House have embraced certain Internet technologies that emphasize brevity, such as blog entries and Twitter, the Agency should facilitate the use of such technologies by biopharmaceutical manufacturers,” Johnson continued in the statement.

Rohit Bhargava, a founding member of the digital influence group at Ogilvy Public Relations Worldwide, also weighed in.

Winter covered technology policy issues for five-and-a-half years as a reporter for the National Journal Group. She has worked for USA Today, the Washington Times, the Magazine Group, the State Department’s International Visitor’s Program, and the Council on Hemispheric Affairs. She also taught English at a university in Tegucigalpa, Honduras.

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