FDA in the News Again

The Government Accounting Office (GAO) released a report earlier this week which says, "FDA lacks a clear and effective process for making decisions about, and providing management oversight of, postmarket drug safety issues."

The report was released by Senate Finance Chairman Charles Grassley, who requested the report in late 2004 on the heels of the withdrawal of Vioxx by Merck and Co, Inc. Grassley said, "This report provides solid evidence that everything is not all right at the FDA and calls for long overdue reform. The FDA’s problems are systemic and cultural, not isolated or easily fixed."

Stay tuned, as Congress decides how to go about "fixing" the FDA.

What does this mean for us as we go about our daily business of manufacturing products regulated by FDA?

Be sure our people are well trained in cGMPs as well as our internal policies and procedures. It’s likely that those employed by FDA will "hunker down and play it safe" (being very cautious and conservative) while they are under the microscope.

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