Report: FDA strengthens monitoring of post-approval drug safety

A strengthened and modernized postmarket drug safety program has resulted in a substantial improvement in the U.S. Food and Drug Administration's oversight of drugs once they reach the American public, according to a new report released today 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 postmarket 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 the FDA's Center for Drug Evaluation and Research. "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 introduced a comprehensive plan to strengthen drug safety in 2004 that was further enhanced with the passage of the Food and Drug Administration 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 postmarket studies of drug safety concerns and drug labeling changes when new drug safety information is identified.

Since 2008, the FDA has:
• required 65 safety-related labeling changes, in addition to the safety labeling changes done voluntarily by drug manufacturers

• required manufacturers to implement a variety of Risk Evaluation and Mitigation Strategies (REMS) to ensure that the benefits of a drug or biological product outweigh 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

• doubled staff in CDER's Office of Surveillance and Epidemiology from 123 in 2007, to 245 in 2012. This group of drug safety specialists includes physicians, pharmacists, epidemiologists, and other professionals

• established specific safety positions within each of the Office of New Drugs' 18 divisions that review applications for new drugs. Each division's deputy director for safety and safety regulatory project manager helps ensure the appropriate handling of postmarket safety issues related to the drugs approved within their division.

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:

• the Mini-Sentinel pilot project that enables FDA to assess medical product safety issues by utilizing secure access to the electronic health care information of more than 125 million patients, provided by 17 data partners nationwide

• a new division in CDER's Office of Biostatistics that focuses exclusively on postmarket drug safety

• an expanded program that enables FDA epidemiologists and statisticians to work with outside collaborators who have access to both large population-based health care data and the expertise to use those data for drug safety studies

• advances in pharmacogenomics, or  personalized medicine, to help doctors use genetic testing to anticipate the safety and effectiveness of a given drug for a given patient.