FDA Warns World's Largest Drug Firms Over Internet Ads
April 03 2009 - 6:22PM
Dow Jones News
For the first time, the Food and Drug Administration on Friday
warned 14 of the world's leading pharmaceutical companies about
misleading Internet ads that appear when people do online queries
for their medical products through search engines such as
Google.
The FDA said the ads are misleading because they omit risk
information associated with the products.
Companies that received the letters include Biogen Idec Inc.
(BIIB), Sanofi-Aventis (SNY), Johnson & Johnson (JNJ) and
GlaxoSmithKline (GSK).
Biogen received a warning letter for its multiple-sclerosis drug
Tysabri. The ads say "A Multiple Sclerosis Treatment That's
Different from the Others" or "Satisfied with your MS Medication or
Looking for Something Different?" but don't include any risk
information.
"Their casual approach to Tysabri treatment is extraordinary in
light of the potentially lethal risks of the drug and the stringent
controls over its distribution," the FDA said in its letter to
Biogen on March 26. The letter was posted on the agency's Web site
Friday.
Biogen's ad includes a link to the Web site for the drug, which
does contain the relevant risk information. The FDA said the link
"does not mitigate the misleading omission of risk information from
these promotional materials."
Sanofi received a warning for ads for Plavix, a powerful
anticlotting drug that is the world's second-largest drug by sales.
"The sponsored links misleadingly suggest Plavix is safer than has
been demonstrated," the FDA letter said.
The FDA discovered the ads as part of its routine monitoring of
Internet advertising, said agency spokeswoman Rita Chappelle. She
said the FDA hasn't contacted any of the search engines where the
ads have appeared because the agency doesn't contact third-parties
that carry ads, even if they are violative ads.
The FDA wants the companies to remove the violative ads and
respond to the agency next week.
The other companies that received letter are: Forest
Laboratories Inc. (FRX), Cephalon Inc. (CEPH), Bayer AG (BAYRY),
Pfizer Inc. (PFE), Novartis AG (NVS), Merck & Co. (MRK), Eli
Lilly & Co. (LLY), Roche Holding AG (RHBBY), Genentech Inc.,
and Boehringer Ingelheim Pharmaceuticals Inc. Genentech was
recently acquired by by Roche.
Represenatives for the companies weren't immediately available
for comment.
-By Jared A. Favole, Dow Jones Newswires; 202.862.9207;
jared.favole@dowjones.com