Watson Pharmaceuticals Inc. circulated a misleading advertisement for anemia drug Ferrlecit that made an unsupported claim and failed to disclose the product's approved use and risks, U.S. regulators said late last week.
The FDA objected to a Ferrlecit ad on the journal's back cover that was partly covered by a removable band wrapped around the magazine. The band did not mention the product by name but contained claims that suggested it was promoting Ferrlecit, the FDA said in the letter to Watson. The FDA viewed the two pieces together as one ad.
Ferrlecit is approved for treating iron-deficiency anemia in patients who are undergoing chronic kidney dialysis and receiving supplemental epoetin therapy.
The Food and Drug Administration ordered Watson to immediately stop using the advertising materials, which appeared in the October 2004 edition of the journal Kidney International. <>.The agency also took issue with the claim "easy administration," calling it "misleading at best." Most patients need to have the drug given intravenously over eight or more dialysis sessions and may require lab tests to monitor iron levels.
Comment: If the FDA can't keep tabs on a company on a timely basis, how can the consumer possibly keep up with information? The advertisement appeared nearly seven months ago, and last week there was an admonishment? How effective is that?