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FDA Promises To Improve Drug Safety

January 31, 2007

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After years of criticism of its drug safety standards, the Food and Drug Administration has outlined steps it intends to take to improve the safety of prescription medication.

The new steps are designed to make sure concerns about potential drug safety are widely circulated within the agency before a drug receives approval.

"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."

Consumer advocates have long maintained the agency has considered the drug manufacturers' point of view over that of the consumer -- a charge the FDA vigorously denies. However, it remains a fact that some drugs receive approval and are used by millions of consumers before problems are uncovered.

The most serious case involves Merck & Co.'s painkiller Vioxx.

The drug received FDA approval and became one of Merck's biggest moneymakers before the company voluntarily withdrew it from the market in September 2004. The action followed discovery that use of the drug increased the risk of heart attacks and strokes. Merck faces more than 1,000 lawsuits from consumers who claim the company new of the problems for years before pulling Vioxx from the market.

In setting out new steps, the FDA said it is responding to a a set of recommendations made by the Institute of Medicine, released in September 2006. The agency said it carefully considered recent IOM recommendations, along with advice from other experts, for making needed advances in the system. FDA said it agrees with the IOM that FDA's mission requires the agency "to balance expeditious access to drugs with concerns for safety."

The FDA said it 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. The FDA said 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.

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