Guest guest Posted June 9, 2011 Report Share Posted June 9, 2011 There has been a large increase in drug shortages during 2010 and continuing into 2011, particularly for sterile injectables so often used in hematological cancers. There was an FDA presentation made recently to FDA patients reps such as myself by the very understaffed office (total of 4 persons) that deals with drug shortages. I have listed an FDA link below to the information provided by this office. The FDA is legislatively limited in the steps it may take trying to avoid the impact of drug shortages and discontinuance. A manufacturer is under no legal obligation to notify FDA of a drug discontinuance, nor is there a penalty for not notifying the FDA. Two specific clinical trials were mentioned which are threatened by drug shortages. There are professional organizations organizing and lobbying to add more teeth to the regulations, most active evidently is the American Society of Health-System Pharmacists: http://www.ashp.org/shortages http://www.fda.gov/Drugs/DrugSafety/DrugShortages/default.htm Quote Link to comment Share on other sites More sharing options...
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