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 by the agency’s Center for Drug Evaluation and Research (CDER). The report, “Advances in FDA’s Safety Program for Marketed Drugs,” describes new scientific tools and enhanced capabilities that give the same priority to post-market drug safety monitoring as to premarket drug review.
The report says CDER is also delivering earlier, more effective drug safety information to the public to protect patients from harm. In 2011, CDER issued 68 drug safety communications—up from 39 in 2010. The communications provide early information to patients and health care professionals about drug safety issues as they emerge.
“Our oversight of the safety of marketed drugs has changed significantly over the past few years,” said Janet Woodcock, M.D., director of CDER. “This report 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.”
CDER introduced a comprehensive plan to strengthen drug safety in 2004 that was further enhanced with the passage of FDA Amendments Act (FDAAA) 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.
Since 2008, the FDA has:
New programs such as Safety First, Sentinel, and Safe Use all demonstrate CDER’s work to strengthen the critical sciences that underpin drug safety monitoring. These new capabilities advance the FDA’s ability to track drug safety concerns, identify potential safety signals early, analyze data for its clinical significance, and determine whether a regulatory change or other solution is needed to further protect patients from drug risks.
Specific examples of the FDA’s use of new drug safety tools include: