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FDA Says Humira Ad Misleading

The Food and Drug Administration said that Abbott Laboratories downplayed the risks associated with the psoriasis therapy Humira (adalimumab) in an ad intended for dermatologists. The ad was 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 noted. The drug has many risks, including tuberculosis and invasive fungal infections, and its use should be carefully weighed, the agency wrote in a December letter to Abbott, which contended that the ad gave a full description of the drug's approved use only in small, "nearly illegible" text. Also, the patient pictured in the ad was not representative of approved users since the model showed only a small area of plaque psoriasis. The agency said Abbott should immediately stop the ads. A company spokeswoman said the ad was discontinued in October and that it will "work with the agency to address their concerns."

Phototherapy Copays Prompt Action

The National Psoriasis Foundation has written to insurance commissioners in six states to request that they encourage health plans to eliminate or reduce patients' copayments for phototherapy sessions. Members of a foundation task force on the issue—who are primarily dermatologists—decided to target commissioners in California, Massachusetts, Missouri, New York, Texas, and Utah. The foundation has received two responses, neither of which was very encouraging, said Sheila Rittenberg, the organization's senior director of advocacy and external affairs. The task force effort came after a failed attempt to convince 85 health insurers around the country to cut copayments, she said in an interview. Patients are paying anywhere from $5 to $50 per psoriasis-phototherapy session, and most need several a week, said Ms. Rittenberg. In some cases, she added, patients are being prescribed biologics because they can't afford phototherapy.

Colorings Must Be Declared

Many foods and cosmetics contain carmine and cochineal, but they have been hidden under the rubric of "artificial coloring" or "colors added." The FDA has ruled that manufacturers must clearly state on labels that carmine and cochineal are in those products. The final rule, published Jan. 5, is partly in response to a petition filed by the Center for Science in the Public Interest in 1998. The nonprofit advocacy group contended that because carmine and cochineal extracts—which give products red hues—come from insects, they were the most likely causes of dozens of allergic reactions. The FDA acknowledged that reactions and anaphylaxis have been associated with carmine- and cochineal-colored products, and the agency first proposed requiring disclosure of the two extracts in 2006. But the FDA has refused to ban the colorants. Manufacturers have 2 years to comply with the new labeling requirements.

2009 Predictions on Cosmetic Front

There will be an increase in horror stories about consumers having bargain cosmetic procedures, and Botox will finally get some competition this year, according to a list of predictions from the American Society for Aesthetic Plastic Surgery. The professional society said that the injectable botulinum toxin Reloxin should gain approval in 2009. The organization also said that noninvasive fat-removal techniques will gain credence as they are tested in clinical trials and that men will continue to be a growing segment of the market for cosmetic procedures. The society said its predictions are based on interviews with plastic surgeons.

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