Having been commissioned by the Food and Drug Administration(FDA) to evaluate the U.S. drug-safety system, the Instituteof Medicine (IOM) published a report, The Future of Drug Safety,in September 2006 identifying weaknesses in the laws, regulations,resources, and practice of ensuring drug safety.1 Some of theIOM's recommendations were directed toward Congress, which itbelieved should increase FDA funding and regulatory authority.Some outlined ways in which other federal agencies could workin partnership with the FDA for the public good. But most ofthe report outlined deficiencies that the FDA itself —or the Department of Health . . . [Full Text of this Article]
Source Information
Dr. Smith is an associate professor at the Center on Drugs and Public Policy, Department of Pharmaceutical Health Services Research, University of Maryland School of Pharmacy, and in the Department of Epidemiology and Preventive Medicine, University of Maryland School of Medicine — both in Baltimore.
Hoffman, J. M., Shah, N. D., Vermeulen, L. C., Doloresco, F., Grim, P., Hunkler, R. J., Hontz, K. M., Schumock, G. T.
(2008). Projecting future drug expenditures--2008. Am J Health Syst Pharm
65: 234-253
[Abstract][Full Text]
Galson, S. K., Smith, S. W.
(2007). The FDA and the IOM Report. NEJM
357: 2520-2522
[Full Text]