FDA Attorney Edward Allera Quoted on Sponsored Link Ads in Nature Biotechnology

Edward John Allera, chairman of the Buchanan Ingersoll & Rooney's FDA/Biotechnology Section and a managing shareholder of the firm's Washington, D.C., office, was quoted in a May 1, 2009, article published by Nature Biotechnology magazine. The article, titled "FDA on warpath for Google links," reported on recent measures taken by the U.S. Food and Drug Administration (FDA) to crackdown on sponsored Google links.

As explained in the article, 14 companies received letters last month from the FDA warning them to remove sponsored link ads, which do not meet FDA risk-disclosure standards, from the internet. "These are the promotional blurbs that are listed on the right-hand side of search engines, such as Google," explained the article. "The crackdown is seen by some as a signal that the FDA is taking a hard line under President Barack Obama."

The agency's Division of Drug Marketing, Advertising and Communications (DDMAC) sent the letters "to convey the message that there's a new sheriff," Allera said. "It's part of setting the tone that we're going to see."

According to the article, the companies had 15 days to respond to the issues raised in the warning letters, but many removed their sponsored links within the first week of receiving notice.

"What people do in these situations is simply pull back," Allera said, "As none of them wants to make an enemy of the FDA with a legal challenge they might lose."