In a recent report, the U.S. Government Accountability Office (GAO) found that FDA's postmarket drug safety program remains deficient, although improved since GAO last looked at the program in 2006. Since that time, Congress passed the FDA Amendments Act of 2007, which greatly enhanced FDA's postmarketing authority over new drugs and thereby expanded its workload.

The report found that while FDA has increased the staff for its postmarketing program, more needs to be done in terms of manpower, funding and modern data systems. The report also noted that the relevant office, the Office of Surveillance and Epidemiology (OSE), still lacked adequate authority and independence, and that functions are still carried out by the Office of New Drugs that should be transferred to OSE. These functions include review of protocols and findings of observational epidemiological studies, as well as of medication error risk studies.