Agency 'declassifies' its secret promotion policy

Share this article:
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.
Share this article:
close

Next Article in Features

Email Newsletters

More in Features

Read the complete April 2014 Digital Edition

Read the complete April 2014 Digital Edition

Click the above link to access the complete Digital Edition of the April 2014 issue of MM&M, with all text, charts and pictures.

Antidote: Are e-cigarettes safe?

Antidote: Are e-cigarettes safe?

The pros and cons of e-cigarettes

Combating concept churn

Combating concept churn

There's no cure. But the good news is that prophylaxis is possible.