Current US drug safety system is moving toward a delay in drug approval
May 9, 2006 18:00

Current US drug safety system is moving toward a delay in drug approval

"The current system is moving toward a delay in drug approval, still followed by optional postmarketing studies," notes Strom, , Brian L. Strom, MD, MPH, Professor of Public Health and Preventive Medicine and Chair of the Department of Biostatistics and Epidemiology at the University of Pennsylvania School of Medicine. "Instead, the proposed approach would be conditional approval followed by postmarketing studies required before the condition is removed."

Strom writes, "the net effect of [the current system] is that the public misunderstands drug safety, believing that a drug is safe at the time of marketing, while [adverse] events occurring as frequently as 1 in 1000 are predictably undetected."

"A key benefit of this proposed approach for the public would be that drug use immediately after marketing would be reduced to those who truly need the drug, in whom the risk-benefit balance in the face of uncertainty is more favorable," Strom says.