FDA requires advertising of laser refractive surgery to include risk information

The U.S. Food and Drug Administration recently issued a notice that requires eye care professionals to include risk information in the advertising and promotion of laser refractive procedures, including LASIK.

The FDA first outlined advertising and promotion regulations in a letter to eye care providers in May 2009. The letter stemmed from an April 2008 public hearing at which the FDA's Ophthalmic Devices Panel learned that some eye care providers failed to inform patients about the indications, limitations, and risks of refractive surgery and the lasers used in those procedures, according to the notice.

"The FDA continues to receive information concerning improper promotion and advertising practices by eye care professionals," Steven Silverman, director of the Office of Compliance at the FDA's Center for Devices and Radiological Health, said in the notice. "The agency is writing again to eye care professionals to emphasize the importance of providing adequate risk information in their advertising and promotion of FDA-approved lasers used in refractive procedures and to advise these professionals where to get additional information, if needed."

Risk information may include side effects, warnings, precautions and contraindications, the notice said.

Any person who misrepresents a restricted device through false or misleading advertising is deemed in violation of the Federal Food, Drug, and Cosmetic Act and is subject to enforcement action, the notice said.

"It is critical to 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 devices' use," Mr. Silverman said in the notice. "Advertisements and promotional materials that do not include appropriate risk information may be misleading."

Eye care professionals must correct advertisements and promotional materials within 90 days of the issuance of the notice. After 90 days, the FDA may take regulatory action against providers whose advertising and promotional materials violate the Food, Drug, and Cosmetic Act.

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Questions and comments may be sent to Deborah Wolf, Regulatory Counsel, CDRH, Office of Compliance, at 301-796-5732.