FDA Orders Allergan To Pull Botox Ads, Brochures, Calling Them Misleading
The FDA has ordered Botox manufacturer Allergan to "immediately" pull all Botox television ads and brochures that contain certain statements the agency says are "misleading," the Wall Street Journal reports. Allergan officials, however, said that they will not pull the promotional materials, stating that the company collaborated with the FDA on the advertising campaign. The FDA in April approved the drug to "temporarily improve the appearance of moderate to severe frown lines between the eyebrows" and stipulated that Allergan is permitted to advertise Botox for these approved uses but not for other "off label" purposes, such as the treatment of other wrinkles. FDA officials contend that some of Allergan's promotional materials misleadingly imply that Botox is approved to treat all "tough wrinkles" and do not make it clear that the effect is temporary. The FDA also objects to materials intended for doctors that the agency says could "confuse the physician and/or promote off-label use."
Christine Cassiano, a spokesperson for Allergan, said that the company "worked diligently" with the FDA while preparing the advertising material. She added that the FDA's criticism of the Botox ads is "factually incorrect and taken out of context" and stated that the company has no plans to change or pull any of the advertising material (Adams, Wall Street Journal, 9/10). Several doctors added that they did not understand the FDA's problems with the Botox ads. Dr. Richard Glogau, a clinical professor of dermatology at University of California-San Francisco, said that doctors are "not concerned about the advertisements, only about unqualified physicians trying to perform the procedure" (White, Los Angeles Times, 9/10). Allergan is drafting its official response to the FDA's requests, but if a compromise is not reached, the FDA could send a warning letter to the company. If the issue remains unresolved, the agency could take Allergan to court (Wall Street Journal, 9/10).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.