FDA's enhanced drug safety program is effective, CDER report says

FDA has strengthened its oversight of drugs after they’ve been approved, thanks to its updated postmarket drug safety program, 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, says that FDA now is able to oversee the safety of postmarket drugs “with the same rigor and focus” that it gives to premarket review.

“This report shows that the quality, accountability, and timeliness of postmarket drug safety decisions have been enhanced, and our public communication of this information is more effective," CDER Director Janet Woodcock, MD, said in an FDA news release.

According to the report, CDER issued 68 drug safety communications in 2011 compared to 39 in 2010. These “communications provide early information to patients and healthcare professionals about drug safety,” FDA said in the news release.

A comprehensive plan to enhance drug safety introduced by CDER in 2004 was strengthened by the FDA Administration Act in 2007, the agency said.

The report says that changes since 2008 include:

• Requiring drug manufacturers to make 65 safety-related labeling changes.

• Requiring 64 “complex” Risk Evaluation and Mitigation Strategies be implemented to assure that benefits of a medication or biologic product outweigh the risks.

• Increasing staff in CDER’s Office of Surveillance and Epidemiology from 123 in 2007 to 245 in 2012.

• Setting up safety positions within each of the Office of New Drugs’ 18 divisions.

"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,” FDA said.