A strengthened and modernized post-market drug safety program has resulted in a substantial improvement in the FDA's oversight of drugs once they reach the American public, according to a new report released by the agency's Center for Drug Evaluation and Research.
CDER introduced a comprehensive plan to strengthen drug safety in 2004 that was further enhanced with the passage of the Food and Drug Administration Amendments Act of 2007. FDAAA authorized major changes to how the safety of drugs would be monitored once on the market, giving FDA the authority to require post-market studies of drug safety concerns and drug labeling changes when new drug safety information is identified.
According to the report, the FDA has accomplished the following since 2008:
• Required 65 safety-related labeling changes, in addition to the safety labeling changes done voluntarily by drug manufacturers.
• Required manufacturers to implement a variety of risk evaluation and mitigation strategies.
• Doubled staff in CDER's Office of Surveillance and Epidemiology from 123 in 2007 to 245 in 2012.
The CDER has also launched new tools and projects to improve drug monitoring safety, including a new division in CDER's Office of Biostatistics that focuses exclusively on post-market drug safety, and the Mini-Sentinel pilot project, which enables the FDA to assess medical product safety issues by enabling secure access to the electronic healthcare information of more than 125 million patients.
CDER introduced a comprehensive plan to strengthen drug safety in 2004 that was further enhanced with the passage of the Food and Drug Administration Amendments Act of 2007. FDAAA authorized major changes to how the safety of drugs would be monitored once on the market, giving FDA the authority to require post-market studies of drug safety concerns and drug labeling changes when new drug safety information is identified.
According to the report, the FDA has accomplished the following since 2008:
• Required 65 safety-related labeling changes, in addition to the safety labeling changes done voluntarily by drug manufacturers.
• Required manufacturers to implement a variety of risk evaluation and mitigation strategies.
• Doubled staff in CDER's Office of Surveillance and Epidemiology from 123 in 2007 to 245 in 2012.
The CDER has also launched new tools and projects to improve drug monitoring safety, including a new division in CDER's Office of Biostatistics that focuses exclusively on post-market drug safety, and the Mini-Sentinel pilot project, which enables the FDA to assess medical product safety issues by enabling secure access to the electronic healthcare information of more than 125 million patients.
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