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Print Edition StoriesWednesday, February 3, 2010
Millipore flu product marketing gets FDA cease order
By Julie M. Donnelly
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The U.S. Food and Drug Administration has ordered Millipore Corp. to cease marketing unapproved products designed to diagnose the H1N1 virus.
The FDA specifically took issue with a Nov. 5 promotional e-mail from the company, titled “Influenza Diagnostics,” claiming that its so-called light diagnostics can be used to diagnose the H1N1 virus.
The FDA objected to the following excerpts from the e-mail:
• Flu A Diagnostics that detect H1N1: Light Diagnostics brand respiratory screens and panels.
• Antibodies to Flu A show high sensitivity and specificity to 2009 H1N1 variant.
The FDA has since told Billerica-based Millipore (NYSE: MIL) to “cease marketing unapproved, uncleared, or unauthorized products for the diagnosis, mitigation, prevention, treatment, or cure of the H1N1 Flu Virus.”
In a letter to the company, the FDA warned that failure to do so could result in enforcement actions including seizure of the product, or civil penalties.
Karen Marinella Hall, a spokeswoman for Millipore, said the violation was the result of one product manager’s promotional e-mail. “We have been in touch with the FDA and have taken corrective actions to make sure this doesn’t happen again,” Hall said.
Certain products related to H1N1 have received permission for marketing prior to approval by the FDA, due to the public health emergency declared by The U.S. Department of Health and Human Services. However, Hall said that Millipore’s products were not part of this exemption.
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