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John Bisnar
John Bisnar
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FDA Promises Improved Drug Safety

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After years of criticism of its drug safety standards and the much-publicized Vioxx scandal, the Food and Drug Administration is now proposing steps to improve the safety of prescription medication.

According to an article on www.consumeraffairs.org, the new steps are designed to make sure concerns about potential drug safety are widely circulated within the agency before a drug is given the stamp of 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 criticized the federal agency saying that it has been partial to the needs of drug manufacturers rather than consumers. FDA officials have long denied that charge vigourously. However, as evidenced by the Vioxx debacle involving pharmaceutical company Merck, which has been the most serious case affecting hundreds of thousands of consumers nationwide, some drugs do receive approval and are used by millions of consumers before the problems are detected or uncovered.

Vioxx received FDA approval and became one of Merck’s biggest moneymakers before the company voluntarily withdrew it from the market in September 2004. That action was prompted by the 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 knew of the problems for years before pulling Vioxx from the market. Bisnar|Chase is representing 50 of those consumers who are waiting for their trials.

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: 1. 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 2. Improving communication and information flow among all stakeholders engaged in promoting the safe use of medical products 3. Improving operations and management to ensure implementation of the review, analysis, consultation, and communication processes needed to strengthen the U.S. drug safety system.

Although it is a blessed relief that the FDA is doing something about tightening its approval process, it must be noted that the damage is done. Vioxx has already caused a quarter million deaths in our country. We can only hope that catastrophic debacles of this nature don’t repeat and that the FDA learns to listen and show some empathy to consumers.

If you or a loved one has suffered the effects of Vioxx or other defective drugs, I can help.