AMERICAN GUINEA PIG: Everything That's Wrong with the FDA and How to Avoid Becoming One of Its Victims

“[The] FDA lacks clear and effective processes for making decisions about, and providing management oversight of, postmarket safety issues.”

- Government Accountability Office, March 2006.

The above statement was made by the United States Government Accountability Office (GAO) following a 16-month investigation of the FDA, requested by the Senate Finance Committee and the House Committee on Energy and Commerce. The report adds, “GAO observed that there is a lack of criteria for determining wh...