“Adverse Events Reports relied upon by the FDA to monitor mifepristone’s [RU-486’s] postmarking safety are grossly deficient due to extremely poor quality.”
Margaret M Gary, M.D., Donna J Harrison, M.D. “Analysis of Severe Adverse Reactions related to the use of Mifepristone as an Abortifacient”, 40 (2) Annals of Pharmacology 191 (2006)
“[A] Majority of the AERs [adverse events reports] analyzed do not provide enough information to accurately code the severity of the adverse event in question. The deficiencies were so egregious in some instances as to preclude analysis.”
“Adverse Event Reporting systems typically detect only a small proportion of events that actually occur.”
Michael F Mangono, Principal Deputy Inspector General Of the Department Of Health And Human Services, in testimony before the US Senate committee.
Hearing on consumer safety and weight loss supplements before the subcommittee on oversight of gov. Management, restructuring and the District of Columbia, S. Comm on Government Affairs 107th Cong. (2002) (statement, by Michael F Mangono, Principal Duty Inspector General, office of Inspector General,, US Department of Health & Human Services)
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