FDA warns Lilly for Alimta marketing
By The Associated Press
Monday, July 31, 2006 11:31 PM EDT
INDIANAPOLIS - Federal regulators asked pharmaceutical maker Eli Lilly and Co. on Monday to withdraw a ‘‘misleading'' marketing brochure for its cancer drug Alimta.
The Food and Drug Administration said Indianapolis-based company published a 34-page patient brochure that ‘‘omits material facts and risk information essential to the safe and effective use'' of the 2-year-old drug.
Alimta is used to treat mesothelioma and non-small cell lung cancer. It can also cause fetal harm to women who take the medication while pregnant.
Last year the drug accounted for $463 million in sales.
Company spokesman Greg Clarke said Lilly had not received the FDA notice, which was posted on the agency's Web site Monday.
‘‘We will naturally work with the agency to make sure the information that's relevant and important for patients is out there, but we've not actually formally received the letter,'' Clarke said.
He added the notice was not a formal warning letter but ‘‘the first level of notification, the lowest level of enforcement the agency takes.''
Specifically, the FDA said Lilly failed to explain what cancers the medication was approved to treat. The brochure, which has a 2004 copyright, also failed to provide a warning about administering the drug during pregnancy.
Lilly has until Aug. 11 to respond to the FDA's drug marketing division about how the company will discontinue the brochure.
The Associated Press left a message for an FDA spokeswoman.
Lilly shares fell 14 cents, or 0.3 percent, to $56.77 in trading Monday on the New York Stock Exchange.
Print this story | Email this story
|
