BioCentury
ARTICLE | Regulation

The warning to Sonus

April 13, 1998 7:00 AM UTC

The FDA's Division of Drug Marketing, Advertising and Communications (DDMAC) has few obvious teeth when it comes to companies found promoting their products before they receive FDA approval: it does not levy penalties such as fines, or impose regulatorily mandated delays in product approvals or restrictions on marketing.

Companies therefore may seem to have little to lose except a slap on the wrist if they engage in a bit of pre-approval promotion. But there is always the fear, if only expressed in private, that the FDA can find ways to penalize companies that the agency believes is flouting its oversight...