FDA Improves Drug Safety

Drugs already on the market are no longer a low safety priority

(RxWiki News) Through recent program enhancements, the FDA’s Center for Drug Evaluation and Research (CDER) has strengthened monitoring of currently available drugs and communications about drug safety issues to the public.

After the CDER introduced a comprehensive plan to strengthen drug safety in 2004, many important improvements have been made. 

A report recently published by the FDA “…shows that the quality, accountability, and timeliness of post market drug safety decisions have been enhanced, and our public communication of this information is more effective.”

"Report all adverse drug reactions to your physician."

Until recent passage of the Food and Drug Administration Amendment Act (2007) and the wide-ranging action plan put in place by the CDER, drugs on the market were not receiving as much attention as drugs seeking FDA approval. 

With enhanced oversight, the FDA now has authority to require investigations into drug safety for drugs already available.  The FDA can also require changes to the labels on drugs when safety concerns arise.

In order to keep up with the increased workload of monitoring currently available drugs, the CDER has doubled the staff in the Office of Surveillance and Epidemiology from 123 in 2007 to 245 in 2012.  Safety positions in each of the Office of New Drugs’ 18 divisions have also been established. 

These divisions review applications for new drugs and make sure all safety issues related to already approved drugs are handled properly. 

All of these elements and more have come together to create a safer environment for the general public.  While drug oversight during the trial phase is important, the FDA has shown through these important improvements that monitoring the drug after its availability to the public is equally important.

The FDA announcement was released April 21, 2012 and the report was released in April of 2012.

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Review Date: 
April 23, 2012