Drug ad violations rising, biologics numbers down

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Enforcement trends in recent years between the FDA's Center for Drugs and its Center for Biologics, as measured by numbers of citations for violating advertising/promotion regulations, appear to be on divergent paths—with increased actions being taken against drug advertisers and declining numbers of actions against biologics.

At a recent Food and Drug Law Institute conference, the FDA's DDMAC director Thomas Abrams said possible reasons for the upward trend in his enforcement actions may be more aggressive promotion on the part of drug advertisers, as well as better prioritization of agency resources in order to have greatest impact on public health.

He said a total of 15 Warning Letters were issued in 2005, and 14 such letters in each of the past two years—up from a previous average of four or five annually.

Abrams' Biologics Center counterpart, Ele Ibarra-Pratt, told the meeting that actions against biologics advertisers have gone from a peak of seven untitled letters and six Warning Letters issued in 2004 to two so far this year.

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