FDA Nails Big Pharma on Internet Ads

April 28th, 2009 | Sources: Wall Street Journal

The FDA has told 14 pharmaceutical companies to bag certain drug ads that accompany search results generated by Google because they don’t include adequate risk information and sometimes suggest non-approved uses.

The directive represented the first salvo in what will likely become a new regulatory frontier, as Big Pharma has begun a major push to redirect marketing dollars towards Internet advertising.

thatsano-noThe ads in question are known as “sponsored links.”

These short teasers appear alongside search lists generated in response to keyword strings that include certain diseases or drug names.

Biogen Idec has received notice from the FDA regarding its MS drug Tysabri, for example.

The drug has been linked to progressive multifocal leukoencephalopathy, an often fatal viral infection of the brain.

One sponsored link for Tysabri asks “(are you) satisfied with your MS medication or looking for something different?” The ad mentions nothing about PML.

This “casual approach to Tysabri treatment is extraordinary in light of the potentially lethal risks of the drug and the stringent controls over its distribution,” wrote the FDA in a letter to Biogen that was obtained by the Wall Street Journal.

Biogen spokesperson Naomi Aoki said her company is working to resolve the situation, and that it takes seriously its responsibility to convey the truth about the risks and benefits of its drug.

The Biogen ad includes a link to the Tysabri Web site which does provide ample risk information, but the FDA was having no part of it. The link “does not mitigate the misleading omission of risk information from these promotional materials,” it wrote.

Sanofi-Aventis received a similar letter for Plavix, its anticlotting blockbuster. Pfizer was cited for 6 of its drugs including the antismoking drug Chantix and Celebrex, an arthritis drug.


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