Thursday, January 29, 2004
Prescription Drugs

FDA Prescription Drug Ad Enforcement Declines Again

The new report prepared at the request of Rep. Waxman finds that FDA enforcement of provisions barring false and misleading advertisements has continued to decline. The number of enforcement actions initiated by FDA in response to false and misleading advertisements fell in 2003. In total, the number of enforcement actions initiated by FDA in 2003 was 75% lower than the average number initiated during the last years of the Clinton Administration. FDA’s responses to false and misleading advertisements were not timely, and delays increased. When FDA did initiate an enforcement action in 2003, the action was often unduly delayed. In 2003, the average delay between ad placement and FDA action was 177 days - almost six months. This is a significant increase in delay compared to 2002. The few actions taken by FDA have little deterrent effect. The enforcement actions that FDA took in 2003 were restricted to sending letters to drug manufacturers warning the manufacturer to cease using an advertisement. Although FDA has the authority to take stronger actions with more deterrent effect, such as bringing a court action seeking an injunction or ultimately a fine against a manufacturer, FDA initiated no such actions in 2003.