McNeil receives FDA warning letter

ROCKVILLE, Md. As a stark reminder that the Food and Drug Administration under the Obama administration will act decisively and publicly, the FDA held a press conference Friday morning announcing that the agency earlier that morning issued McNeil Consumer Healthcare a warning letter for “multiple violations of current good manufacturing practices.”

“We’re working with the FDA to respond to their concerns,” said McNeil Consumer spokeswoman Bonnie Jacobs. McNeil declined to comment further.

The warning letter comes on the same day that McNeil issued a voluntary recall of more than 500 lots of products, including several Tylenol products and other brand names like Motrin, Rolaids, Simply Sleep and St. Joseph’s Aspirin.  The products were recalled because of a possible chemical contaminant in the packaging that caused non-serious adverse events, such as nausea, diarrhea and vomiting.

“The FDA recognizes that McNeil is taking more extensive steps today to deal with the problem, including recalling lots that have not been the subject of consumer complaints,” Deborah Autor, director of the Office of Compliance, Center for Drug Evaluation and Research at the FDA told reporters. “However, McNeil should have acted faster. McNeil, and all drug manufacturers, have a corporate responsibility to assure that their products are high quality, safe and effective. When problems arise with their products, they must be proactive, quick and thorough,” she said. “When something smells bad, literally or figuratively, companies must aggressively investigate and take all necessary actions to solve the problem,” Autor added, referencing an odor associated with the contaminated products.

The FDA reported that the first consumer complaints received by McNeil for this issue occurred in September 2008. “However, McNeil did not notify the FDA of these complaints until a year later in September 2009,” Autor said. “Since the FDA became aware of the situation, the agency has repeatedly urged McNeil to identify the source of the problem and its scope and to recall any affected product.”