Reprinted with permission from www.fdaweb.com
09/28/2011
FDA Warns Against Illegal LASIK Ads — Again

Despite a 5/22/09 letter to eye care professionals cautioning against inappropriate advertising and promotion of FDA-approved lasers used in refractive procedures such as LASIK, FDA says it continues to receive information concerning improper promotion and advertising practices by eye care professionals. So it is writing to them again.

In a 9/23 letter, FDA says it wants to “emphasize the importance of providing adequate risk information in [your] advertising and promotion of FDA-approved lasers used in refractive procedures, and to advise these professionals where to get additional information, if needed.”

FDA says it expects that the notice and information about FDA resources on approved lasers and their associated risks will be sufficient to enable eye care professionals to correct within 90 days any ads or promotional materials that don’t comply with the Federal Food, Drug, and Cosmetic Act. “After that time,” it warns, “FDA may take regulatory action against eye care professionals whose advertisements or promotional materials violate the FD&C Act. Agency actions may include Warning Letters, product seizures, injunctions, and civil money penalty proceedings.”

The letter notes that it is critical that eye care professionals disclose risk information appropriately and effectively to consumers in all advertisements and promotional materials concerning restricted devices, including the consequences that may result from the device’s use. “FDA believes that eliminating false or misleading health-related advertising, as well as false or misleading product labeling, is an important part of protecting the public health,” it concludes.