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Institute calls for label symbol, funding, and reorganization to fix drug safety

More and more people are beginning to think that the FDA system for assuring the safety of drugs - especially new drugs - is broken.

One could read recent headlines about Food and Drug Administration-approved new drugs that, within a few years of their approval, are the subject of serious health questions and get pulled from the market. Vioxx was the most prominent recent example, but there have been others. There was a time when FDAers would say that kind of thing only happened in Europe, so when critics asserted that some drugs got approved there that didn't get approved here, the FDA would counter by saying it is more careful, since the Europeans pulled more drugs back off the market after approval. It appears that is no longer so.

The federal Institute of Medicine (IOM), an independent study group on science and medicine matters, said in a recent report that there are fundamental flaws in the way the FDA regulates drugs.

IOM said that the perception is widespread among industry, Congress, healthcare entities and others, that something needs fixing, and points to inadequate resources for science and organizational problems within the FDA Center for Drug Evaluation and Research, among other difficulties. The report recommended a series of steps, including more funding and staff for the FDA to address drug safety issues. IOM also called for a label symbol for new drugs that would appear for two years after approval, to give doctors and patients a heads-up that the risks of a drug might not yet be fully understood.

The FDA, Congress, and others will take the IOM recommendations into account as they look ahead to possible changes in FDA powers, organization and funding.

- Eric F. Greenberg, Attorney-at-Law
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