Report Finds FDA Post-Market Oversight of Drugs is Improving

A just-released report finds that the U.S. Food & Drug Administration’s (FDA) oversight of drugs is improving, says the agency.

The report states that the FDA has strengthened the way in which it monitors post-approval drug safety—approved drugs receive equal priority for safety reviews as do drugs undergoing the stringent pre-market review.

A strengthened and up-to-date post-market drug safety program has led to a substantial improvement in the FDA’s oversight of drugs once they reach the American public, according to the new report just released by the agency’s Center for Drug Evaluation and Research (CDER). The report, entitled “Advances in FDA’s Safety Program for Marketed Drugs,” describes new scientific tools and enhanced capabilities that enable the same priority to post-market drug safety monitoring as is given to pre-market drug review. The report can be accessed at:

The report also states that CDER is delivering earlier, more effective drug safety information to the public, which helps to protect patients from harm. In 2011, CDER issued 68 drug safety communications, which is an increase from the 39 issued in 2010. The communications provide emerging information to patients and health care professionals concerning drug safety issues.

“Our oversight of the safety of marketed drugs has changed significantly over the past few years,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “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. The plan was enhanced with passage of the Food and Drug Administration Amendments Act (FDAAA) of 2007, which authorized major changes to the way in which drug safety would be monitored once drugs were approved for market release. The FDAAA also gave the agency authority to mandate post-market studies of drug safety concerns and drug labeling changes when new drug safety information is identified.

Since 2008, the FDA has instituted scores of labeling changes beyond voluntary drug maker changes, and has also mandated drug makers to implement Risk Evaluation and Mitigation Strategies (REMS)—64 complex—to ensure drug or biological products’ benefits outweigh. Staff in the CDER’s Office of Surveillance and Epidemiology was doubled and safety positions within each of the Office of New Drugs’ 18 divisions, which review new drug applications, have been created.

New programs were also implemented to advance the agency’s ability to track drug safety concerns, identify possible safety signals earlier, review data for clinical significance, and determine if changes needed to protect consumers from drug risks. Programs include Safety First, Sentinel, and Safe Use. The Mini-Sentinel pilot project allows the agency to assess medical product safety issues utilizing secure access to the electronic health care information of more than 125 million patients, which is provided by 17 nationwide partners.

A new division was also created in CDER’s Office of Biostatistics that focuses on post-market drug safety and the FDA expanded a program that enables expert external collaboration on advances in pharmacogenomics, which involves genetic testing used to understand drug safety and efficacy, by drug and patient.

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