Abbott’s Humira Marketing Draws FDA Scrutiny

According to the FDA, Abbott Laboratories’ Humira marketing efforts widens the uses for the arthritis drug while downplaying its potential risks. Humira has been approved to treat arthritis, psoriasis, Crohn’s Disease or a form of arthritis called ankylosing spondylitis. However, the federal agency has criticized the pharmaceutical company for a misleading advertisement “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. The warning comes after many other drug makers have been criticized for similarly misleading marketing efforts this past year.
Drugs approved by the FDA may be used for so-called off-label uses by doctors who judge it prudent to do so. However, the pharmaceutical companies are not allowed to market the drugs for such off-label uses or uses for which the FDA has not approved the particular drug.