FDA to change approach with new initiatives announced in response to Institute of Medicine recommendations

The U.S. Food and Drug Administration (FDA) has outlined a comprehensive approach to the safety of drugs and other medical products based largely  to a set of recommendations made by the Institute of Medicine (IOM) in 2006, that details a series of initial steps that address many concerns about drug safety.

"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 Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs.

"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."

In 2005, the FDA asked the IOM for its assessment of the U.S. drug safety system. In September 2006, the IOM released a report, The Future of Drug Safety: Promoting and Protecting the Health of the Public, that included substantive recommendations on how the FDA can improve its drug safety efforts.

The agency carefully considered recent IOM recommendations, along with advice from other experts, for making needed advances in the system. FDA agrees with the IOM that FDA's mission requires the agency "to balance expeditious access to drugs with concerns for safety" (IOM, Sept. 2006).

FDA believes that concrete steps should be taken. The FDA plans to strengthen the drug safety system with a number of actions in support of three key efforts:

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;

FDA initiatives 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.

Improving communication and information flow among all stakeholders engaged in promoting the safe use of medical products; and

FDA initiatives 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.

Improving operations and management to ensure implementation of the review, analysis, consultation, and communication processes needed to strengthen the U.S. drug safety system.

FDA initiatives 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.

In addition, a number of the recently proposed recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA), if adopted by Congress, will respond to some of the IOM recommendations. This will provide significant increased resources for drug safety and added flexibility to FDA in the use of fee funding to address the entire drug life cycle.

The FDA's ongoing effort for drug safety constitutes a comprehensive approach to the IOM's suggestions. It includes 18 actions that were initiated recently as a result of FDA's own assessment of the drug safety system, eight items that are part of the proposed recommendations for the reauthorization of the PDUFA and 15 new items.