FDA Warns Novartis, Glaxo on Marketing Practices

The FDA today released warning letters it has sent to Novartis and GlaxoSmithKline over how the companies promoted two products, Dow Jones Newswires reports.

The agency dinged Glaxo for a professional pullout, or “slim jim” sales aid, promoting Altabax, an ointment that treats the skin condition impetigo. According to the FDA, the pullout makes claims that go over and above its indication — treating only cases of the condition that are caused by certain bacteria. As written, the brochure suggests the ointment can also treat impetigo caused by other bacterial strains — including the infamous MRSA, the FDA says in a letter.

Glaxo said in a statement it responded to the agency, will stop using the brochure and is “carefully reviewing FDA’s comments and issues.”

Novartis was warned about two websites it sponsors, http://www.gistalliance.com and http://www.cmlalliance.com, that didn’t mention the name of Gleevec, the drug the sites were promoting. Gleevec is approved to treat GIST, or gastrointestinal stromal tumor, and a form of leukemia. The content of the websites weren’t submitted for the required prior approval period, the agency says in a letter.

The drug maker didn’t immediately respond to Dow Jones’s request for a comment, but both websites say they’re “temporarily unavailable.”

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By Katherine Hobson
WSJ’s blog on health and the business of health