FDA warns

[Kay]

Abbott Laboratories are in hot water with the Food and Drug Administration for understating the risks associated with their psoraisis drug, Humira. Abbott have until the second day of January 2009 to answer the letter the FDA sent them regarding their concerns.

WASHINGTON (Reuters) - An advertisement for Abbott Laboratories' Humira minimizes the arthritis drug's risks while suggesting it can treat a wider range of patients than it is approved to treat, the U.S. Food and Drug Administration said in a letter released on Tuesday.

The drug is cleared to treat certain patients with arthritis, psoriasis, Crohn's Disease or a form of arthritis called ankylosing spondylitis.

But the ad, used in a trade publication for doctors, "is misleading because it suggests that Humira is useful in a broader range of conditions or patients than has been demonstrated by substantial evidence or substantial clinical experience," the FDA wrote in the December 16 letter to the drugmaker.

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[Kay]

Abbott's days are just getting worse! Bayer is now suing them for patent infringement for this very same product, Humira. With all the trouble it's causing, you'd think they'd be dropping it like a hot potato.

Bayer's lawsuit was filed six years after Humira was approved for U.S. sales -- and in the plaintiff-friendly U.S. District Court for the Eastern District of Texas. The lawsuit seeks triple damages for past and future patent infringement, attorney fees and other relief, but does not seek to halt sales of Humira.

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