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FDA warns
14 Pharmaceutical Companies about short
Internet Ads that do not contain risk
information
[Apr 06, 2009]
FDA
has warned 14 major pharmaceutical firms
about brief Internet advertisements that
could have misled patients because they did
not include information about health risks
related to the drugs, according to letters
posted to the agency's Web site Friday, the
Wall Street Journal
The ads cited in the letters typically
appeared as "sponsored links" when a user
typed the name of a disease or drug into a
search engine.
The violations were identified during
routine monitoring of Internet advertising
conducted by the agency, spokesperson Rita
Chappelle said.
According to Chappelle, 19 of the 48 drugs
cited by FDA carry "black box" warnings, the
agency's strongest warning for side effects.
In addition, some of the ads included
information on uses beyond those approved by
the agency.
The letters stated that the companies should
remove any ads that include no mention of
related health risks and respond to the
agency letters this week.
The
Journal
reports that the "warnings marked one of the
first major actions by the FDA to crack down
on Internet promotion, which is taking a
bigger chunk of pharmaceutical marketing
budgets" as more people use search engines
to seek out information on health problems.
One letter, dated March 26, was sent to
Biogen
Idec concerning an ad for its
multiple sclerosis drug Tysabri that lacked
risk information.
The letter said that the firm's "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 drug has been linked to serious brain
infections in several patients and is
subject to sales restrictions intended to
reduce the risk of side effects.
The ad in question contained a link to a Web
site containing relevant risk information,
but the agency in its letter wrote that this
link "does not mitigate the misleading
omission of risk information from these
promotional materials."
Biogen spokesperson Naomi Aoki said that the
firm is working with FDA to resolve the
problem and that it takes its responsibility
to inform consumers of any risks related to
its products "very seriously."
Sanofi-Aventis
also received a letter citing ads for its
anti-clotting drug Plavix, the world's
second-leading drug in terms of sales.
According to the letter, "The sponsored
links misleadingly suggest Plavix is safer
than has been demonstrated."
Other companies receiving letters include
Johnson
& Johnson,
GlaxoSmithKline,
Forest
Laboratories,
Cephalon,
Bayer,
Novartis,
Merck,
Eli
Lilly,
Roche
Holding,
Genentech and
Boehringer-Ingelheim Pharmaceuticals,
which recently was acquired by Roche. FDA
has not contacted search engines where the
ads appeared because its policy is not to
contact third parties that carry drug ads,
even if they violate agency rules, Chappelle
said (Favole,
Wall Street Journal
The
letters are available
online.
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