UPDATE: FDA Warns World's Largest Drug Firms Over Internet Ads
04 4월 2009 - 8:34AM
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 in strongly worded letters to the companies that
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). Some of the letters include complaints about
multiple drugs. For instance, a letter to Pfizer Inc. (PFE)
mentions six drugs, including its anti-smoking drug Chantix and the
arthritis medicine Celebrex.
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."
The company is working closely with the FDA to resolve the
situation, said spokeswoman Naomi Aoki. She said the company takes
its responsibility to communicate the risks and benefits of Tysabri
"very seriously."
FDA spokeswoman Rita Chappelle said 19 of the 48 drugs cited in
the letters carry the agency's strongest warning, a black box,
about side effects. She said in some instances the information on
the ads expanded uses of the drug beyond what they are approved
for.
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, Chappelle said. 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.
Google Inc. (GOOG) spokeswoman Sandra Heikkinen said the
Internet-search company has been working with the pharmaceutical
companies to make sure their ads align with FDA regulations. She
said the companies have control over what appears in the sponsored
ads.
Pfizer has received warnings for sponsored ads related to
Aromasin, Caduet, Chantix, Detrol, Lyrica and Celebrex. The company
said it "recognizes the importance of communicating online about
medical conditions." The company is reassessing its use of
sponsored links to ensure they continue to adhere to the FDA
guidelines."
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),
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 many of the companies weren't immediately
available for comment.
-By Jared A. Favole, Dow Jones Newswires; 202.862.9207;
jared.favole@dowjones.com