Agency 'declassifies' its secret promotion policy

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Twenty months after telling eye care professionals they should report questionable LASIK vision enhancement ads to the agency, FDA in January disclosed a policy of “generally” deferring to the Federal Trade Commission enforcement actions against false or misleading ads and promotions for “restricted” (certain prescription) medical devices.
When the policy came into being was not disclosed, however former FDA director of ophthalmic devices Morris Waxler, who has petitioned the agency to now withdraw all LASIK approvals due to a claimed 20% failure rate, says he remembers close FDA-FTC collaboration on device ad enforcement in the 1990s.
The Food, Drug & Cosmetic Act gives FDA jurisdiction over advertising and promotion of “restricted” devices, while FTC has jurisdiction over the marketing of all other devices, as well as over nonprescription drugs.

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