FDA Cites Becton Dickinson for Selling Unapproved Swine Flu Test Kits
The FDA blasted Becton Dickinson for marketing a bogus swine flu test kit. The FDA’s warning letter, citing “national security” (!), said BD promoted on its web site a “Rapid Influenza Antigen Test (Swine Flu).”
The memo is interesting because it is usually small fly-by-night companies that get caught marketing useless tests and remedies for the disease of the moment. In this case, BD is a major international corporation.
The FDA found that:
These products have not been approved, cleared, or otherwise authorized by FDA for use in the diagnosis, mitigation, prevention, treatment, or cure of the 2009 H1N1 Flu Virus.
… we are confident that our test can detect this newer Type A, H1N1 flu virus …
… since the BD™ EZ Flu A+B assay detects the conserved portions of the influenza nucleoprotein, we understand from the CDC that, in its view, there is no reason that our assay should not work to detect this flu virus.
The FDA said that was “a potentially significant threat to the public health” because the kit has not been FDA approved for swine flu:
FDA is advising consumers not to purchase or use 2009 H1N1 Flu Virus-related products offered for sale that have not been approved, cleared, or authorized by FDA.
Jim Edwards, a former managing editor of Adweek, has covered drug marketing at Brandweek for four years, and is a former Knight-Bagehot fellow at Columbia University's business and journalism schools. Follow him on Twitter or send him an email.
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