To ensure that FDA-mandated postmarket safety trials of medications meet appropriate ethical standards, the Institute of Medicine (IOM) has developed a framework to guide the agency in its decisions regarding such trials.
The IOM published the framework July 9, in advance of a larger report on postmarket drug safety due to be published in 2011 (http://www.nap.edu/catalog.php?record_id=12948). The Food and Drug Administration Amendments Act of 2007 (FDAAA) expanded the FDA authority to monitor postmarket safety of approved drugs, including requiring manufacturers to conduct postmarket safety trials.
Kuehn BM. IOM Advises FDA on Ethics in Postmarket Safety Trials. JAMA. 2010;304(6):627. doi:10.1001/jama.2010.1080