Monitoring Medications After Approval Has Improved Oversight, Says CDER

Monitoring Medications After Approval Has Improved Oversight, Says CDER

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Main Category: Regulatory Affairs / Drug Approvals
Article Date: 23 Apr 2012 - 12:00 PDT

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A more robust postmarket drug safety program has helped improve the FDA's (Food and Drug Administration) oversight of medications after they have been approved, says a report issued by CDER (Center for Drug Evaluation and Research). CDER is part of the FDA.

The authors explained how new scientific tools improved the Agency's capabilities so that drug safety monitoring post-approval can have the same priority as before approval.

The report adds that the public is receiving more effective drug safety data from CDER; information which helps protect medication users from harm.

68 drug safety communications were issued by CDER last year, compared to 39 the year before. The present system allows for prompter communication to doctors and patients regarding medication safety issues as they appear.

CDER director, Janet Woodcock, M.D., said:

"Our oversight of the safety of marketed drugs has changed significantly over the past few years. 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."

A comprehensive plan to enhance drug safety was introduced by CDER in 2004; it was further strengthened in 2007 with the passage of the FDAAA (Food and Drug Administration Amendments Act).

The FDA today, wrote in an online communiqué today:

"FDAAA authorized major changes to how the safety of drugs would be monitored once on the market, giving FDA the authority to require postmarket studies of drug safety concerns and drug labeling changes when new drug safety information is identified."

Since 2008, the Food and Drug administration:

• Has made drug manufacturers carry out 65 safety-related labeling changes, as well as those done voluntarily by the industry


• Has made it a requirement that range of REMS (Risk Evaluation and Mitigation Strategies) be implemented to make sure that the benefits related to a medication or biological product outweight its risks. "FDA has required 64 complex REMS, in addition to a number of less complex REMS. Some of these REMS include plans for restricted access to certain high-risk products."


• Has set up special safety positions inside each of its Office of News Drugs' 18 divisions that examine data from new drug submission. The deputy director for safety in each division, as well as its safety regulatory project manager, in each division help make sure make sure the postmarket safety issues related to medications approved within their division is handled appropriately.

According to the FDA, the following programs have helped strengthen CDER's safety monitoring:

• Safety First
• Sentinel
• SafeUse

The FDA wrote:

"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.

Written by Christian Nordqvist
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

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