FDA Warns Allergan About Botox Advertisements
The FDA in a letter Monday warned officials at Allergan that the company's advertisements for Botox were illegal because they minimized the risks associated with the treatment and promoted Botox for uses not approved by the agency, the New York Times reports. The ads cited by the FDA state that "more than half a million people have already been wowed by Botox Cosmetics, America's most popular cosmetic treatment" and that the FDA has approved Botox as a treatment for "frown lines." The FDA has approved Botox as a treatment for "moderate to severe glabellar lines," or the vertical lines between the eyebrows. Steven Masiello, director of the office of compliance in the Center for Biologics Evaluation and Research at the FDA, said, "We are very concerned that by continuing to promote Botox Cosmetic in a false and misleading manner these materials are raising significant public health concerns." However, Christine Cassiano, a spokesperson for Allergan, said that the company considered the glabellar lines a form of "frown lines." Douglas Ingram, general counsel for Allergan, said that the company would "work with the FDA to satisfy any concerns that they have," adding, "We thought we were complying with guidance previously provided by the FDA." The Monday letter was the second that Allergan received from the FDA over concerns about Botox ads (Petersen, New York Times, 6/24). Last September, the FDA ordered Allergan to withdraw Botox television ads and brochures with certain statements that the agency said could mislead consumers (California Healthline, 9/10/02).
The FDA in a letter on Friday said that Johnson & Johnson's Ortho-Biotech unit was making misleading claims in advertising for its anemia drug Procrit and asked that the ads be withdrawn, the Wall Street Journal reports (Hamilton, Wall Street Journal, 6/25). The drug, known generically as epoetin alfa, has only been approved for use in increasing hemoglobin levels from dangerously low levels -- not to achieve normal hemoglobin levels -- and there is no evidence that Procrit offers any extra benefit to patients who continue to take the drug until they achieve a normal red blood cell count, according to the FDA (Bloomberg/New York Times, 6/25). However, Procrit advertisements claim that the drug can raise red blood cell levels "back to normal" in chemotherapy patients. In a footnote, the advertisement does cite that the treatment's target hemoglobin level range is 12 to 13 grams per decileter -- rather than the FDA's "normal" range of 13.5 to 18 grams per decileter for men and 12 to 16 grams per decileter for women, but the footnote has "extremely small, difficult to find" type, according to the FDA. The ad also claims the drug can improve hemoglobin levels by one decileter or more in four weeks and two grams per decileter in eight weeks and includes a graph showing improvement results from two clinical studies. The FDA said data from those studies do not support the advertisement's claims, which "imply that Procit is more effective with faster [hemoglobin] responses than has been demonstrated by substantial evidence or substantial clinical experience." A J&J spokesperson said the company is "currently assessing the content of the letter and will work with the FDA to resolve the matter as quickly as possible (Wall Street Journal, 6/25).
The FDA also ordered GlaxoSmithKline to remove radio and newspaper ads that suggest that the allergy spray Flonase is interchangeable with antihistamine pills such as Allegra and Zyrtec to treat allergy symptoms. The agency said Flonase only treats nasal symptoms while some antihistamine pills also treat other allergy symptoms such as itchy eyes (AP/Wall Street Journal, 6/25). GSK spokesperson Lisa Behrens said that the company believed it had accurately described differences between its product and other allergy drugs but would "work in compliance with the FDA." The advertisements had already stopped running by the time the FDA submitted its complaint (AP/Philadelphia Inquirer, 6/25).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.