Healthcare Business News FDA outlines steps to enhance agency's postmarket ... - ModernHealthcare.com

The Food and Drug Administration said the agency now provides as much effort in monitoring the safety of approved drugs as it does during the pre-market drug review process.

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The FDA released three reports on Saturday that outline the steps its Center for Drug Evaluation and Research has taken to enhance the agency's postmarket drug safety program.

“Our oversight of the safety of marketed drugs has changed significantly over the past few years,” said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, in a news release. “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.”

Since the Food and Drug Administration Amendments Act was passed in 2007, the FDA has focused on four factors to strengthen the postmaket drug safety program.

The FDAAA also updated the drug industry's five-year user-fee program, which expires this year. Congress is currently reviewing legislation for user-fee programs for the drug, device, generic and biosimilar industries.

According to the “Advances in FDA's Safety Program for Marketed Drugs” report, the areas of focus include developing new capabilities for detecting and responding quickly to postmarket drug safety issues; enhancing the quality, speed, and transparency of the agency's decisions about how to address specific drug safety issues; provider earlier and more effective drug safety communication to the public; and developing stronger protection of patients from preventable medication errors.

The FDA said it has increased the number of drug safety communications to consumers, from 68 in 2011 compared to 39 in 2010.

Other actions taken by the FDA since 2008 include requiring 65 safety-related labeling changes, doubling the staff in CDER's Office of Surveillance and Epidemiology, and introducing the Safety First, Sentinel and Safe Use programs.