FDA Announces New Drug Safety Measures

In a statement issued this week, the U.S. Food and Drug Administration (FDA) announced a renewed commitment to its drug safety system. Based on recommendations from a report by the Institute of Medicine (IOM), the agency outlined a series of immediate steps to ensure their safety procedures are as robust as they need to be.

“Our ongoing assessment of the drug and medical product safety system has affirmed that it is essential that our processes and scientific methods keep pace with the rapid evolution of science, technology and the health care system,” said Dr. Andrew C. von Eschenbach, commissioner of the FDA. “The extensive input we have received from stakeholders has proven invaluable as we transform the drug and medical product safety system and continue to fulfill our mission to protect and promote the public health.”

The FDA highlighted three major areas of concern. The first relates to “strengthening the science that supports the FDA’s medical product safety system at every stage of the product life cycle from pre-market testing and development through post-market surveillance and risk management.” Measures in this area will include “developing new scientific approaches to detecting, understanding, predicting, and preventing adverse events, developing and incorporating new quantitative tools in the assessment of benefit and risk, and conducting a pilot program to review the safety profiles of certain newly approved drugs on a regularly scheduled basis.”

The second initiative is aimed at “improving communication and information flow among all stakeholders engaged in promoting the safe use of medical products.” This would include “the establishment of an advisory committee to provide input to improve the agency’s risk communication policies and practices, conducting a comprehensive review of current public communication tools, and developing a comprehensive risk-communication strategic plan.”

Finally, the FDA is committed to “improving operations and management to ensure implementation of the review, analysis, consultation, and communication processes needed to strengthen the U.S. drug safety system.” To this end, the FDA’s plans “include engaging external management consultants to help the Center for Drug Evaluation and Research (CDER) develop a comprehensive strategy for improving CDER’s organizational culture, and making specific organizational and management changes to increase communications among review and safety staff.”

Other specific actions to be taken by the agency: creating a new Advisory Committee on Risk Communications; implementation of a recently signed agreement between the FDA and the Veterans Health Administration to share information and expertise on the use of FDA-regulated medical products; implementation of an electronic safety tracking system to ensure a consistent approach at the Center for Drug Evaluation and Research (CDER); and an upgrade of AERS II, the second release of the Adverse Events Reporting System database.

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