FDA accuses Pfizer of false advertising

Pfizer's ad for anti-psychotic drug misleading, omits health risk info, says FDA.

By Aaron Smith, CNNMoney.com staff writer

NEW YORK (CNNMoney.com) -- The FDA on Monday accused Pfizer of false advertising for its anti-schizophrenia drug Geodon.

The Food and Drug Administration, in a letter posted on its Web site, said that a Pfizer (down $0.33 to $23.56, Charts, Fortune 500) advertisement appearing in a medical journal "is false or misleading because it omits important risk information and contains unsubstantiated superiority claims."

The FDA said that Pfizer omitted health risks that have been attributed to the injectable drug Geodon, including diabetes, high blood pressure and neurological disorders.

The FDA said that Pfizer used the term "movement disorders" to refer to a disorder called tardive dyskensia, a description that is "insufficient" to communicate its seriousness.

"By omitting these risks, the journal ad misleadingly suggests that Geodon for Injections is safer than has been demonstrated," said the FDA letter.

The FDA also said that the New York-based drug giant claimed Geodon is better than the anti-psychotic Haloperidol IM, "when this has not been demonstrated by substantial evidence or substantial clinical experience."

"We take compliance of promotional rules and regulations very seriously and took the necessary action outlined in the guidance which came from the FDA," said Ray Kerins, a spokesperson for Pfizer.

Geodon sales totaled $400 million in the first half of 2007, according to Pfizer. The drug competes with Johnson & Johnson's (down $0.22 to $61.23, Charts, Fortune 500) Risperdal and Invega, which totaled $2.3 billion in sales during the first six months of 2007, as well as Eli Lilly & Co.'s (down $1.60 to $55.33, Charts, Fortune 500) Zyprexa, Bristol-Myers Squibb's (down $0.38 to $28.58, Charts, Fortune 500) Abilify and AstraZeneca's (down $0.48 to $46.95, Charts) Seroquel. Top of page