Last month, the feds took issue with Bayer's marketing for its Phillips' Colon Health product, saying the company's claims lacked scientific backing. But the way the German pharma sees it, the legal standard the Department of Justice (DOJ) is holding it to is not only unfair, it's unprecedented.
In court documents filed earlier Friday, Bayer said it was being pinned to a "novel and erroneous" legal standard in civil contempt proceedings, the New Jersey Law Journal reports. It believes the U.S. government is wrongly penalizing it for failure to conduct randomized, placebo-controlled, double-blind human clinical trials on the product.
The back story: In 2007, the department slapped Bayer with a court order after it made unsubstantiated claims about a line of One-A-Day vitamins, requiring the company to include evidence to back its product-marketing assertions. Bayer forked over $3.2 million to settle that case, The Wall Street Journal's Pharmalot notes.
And now, the feds say Bayer's Phillips' marketing puts it in contempt of court. The reason? Bayer improperly implies the product--a probiotic--can prevent, cure or treat symptoms of gastrointestinal distress.
But Bayer says its product has undergone enough testing as it is. The consent order requires only that its marketing claims for supplements be supported by "competent and reliable scientific evidence," it said in a statement seen by the NJLJ.
"Claims about Phillips' Colon Health are fully substantiated by numerous clinical, animal and genetic studies, among other things, and satisfy all applicable legal standards," the statement said.
- see the New Jersey Law Journal story (sub. req.)
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