Despite Obvious Blunders, Drug Safety Remains a Low Priority at the FDA

The FDA received some good advice recently from the Institute of Medicine for improving drug safety, yet dismissed it. A new report released by the Democratic minority staff of the House Committee on Government Reform clearly demonstrates the FDA should've been listening.

It revolves around the fact that the number of warning letters issued to drug companies for safety and quality violations has dropped an amazing 54 percent in 2005 from just five years ago, despite growing awareness about the toxic nature of many prescription and over-the-counter (OTC) drugs -- think the deadly antibiotic Ketek.

Even worse, the FDA dismissed at least 32 cases in which field inspectors recommended the agency issue warning letters, court injunctions or product seizures. One case involved three patients admitted to emergency rooms after taking an OTC hangover drug with toxic amounts of caffeine. Inspectors believed these cases merited a warning letter, yet the FDA ruled their concerns failed to meet the necessary regulatory thresholds for enforcement.

If you believe the FDA debacle is a partisan issue emerging during the midterm election season, think again. For one, a recent Government Accountability Office report blasted the agency for lacking the wherewithal to monitor and handle drug safety issues. And, the Congressman who requested the report was Sen. Charles Grassley (R-Iowa), one of the very few lobbying for serious reform.

USA Today June 27, 2006

Washington Post June 27, 2006

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