Reprinted with permission from www.fdaweb.com
Direct from FDA’s “egg on our face” department comes the confession of press officer Karen Riley that she mislaid the answer to our request for clarification about the agency’s jurisdiction/no jurisdiction over “restricted” device advertising, thus missing our deadline. Our story, CDRH Disowns Statutory Authority Over LASIK Ads, attempted to reconcile a 20-month-old CDRH letter to eye care professionals asserting FDA jurisdiction over their LASIK ads with a 1/29 statement that FDA has no jurisdiction because the Federal Trade Commission has that jurisdiction.
Unstated in either letter was this new information, at the bottom of Riley’s seven-line delayed response to our request for clarification: “If statements in advertising and promotional materials do not relate to any of these restricted devices (or other FDA-regulated product), FDA generally defers oversight of such advertising and promotion to the FTC which has authority over unfair and deceptive business practices, including false advertisements related to products and services.”
If injured LASIK patients had known this 20 months ago, they could have sent all their LASIK ad complaints to FTC rather than to CDRH — which apparently ignored them.