Tuesday, June 27, 2006

Study Cites Marked Drop In FDA's Warning Letters

The number of serious "warning letters" sent by the Food and Drug Administration to drug, device and food companies has dropped by half over the past five years, leading to a situation where the agency's ability to ensure that products are being made properly has been "significantly compromised," according to a study by the Democratic staff of the House Government Reform Committee.

In addition to a drop of almost 50 percent in the number of on-site inspections at manufacturing plants, the 15-month probe found that in some cases, FDA headquarters rejected the enforcement recommendations of agency field offices despite inspectors' findings that violations had led to deaths or serious injuries.

In 32 cases, investigators found, field inspectors recommended that the FDA issue a warning letter, seize the product or seek a court injunction, but the agency sent a significantly weaker letter alerting the company to possible problems.

The inspections, warning letters and enforcement actions described in the report involve questions of whether manufacturers are following good manufacturing practices -- whether their pills, medical devices and food products are being produced in a reliably safe manner.

Courtesy of the Washington Post

Steve - we first need to keep in mind the source of the survey. This very well may be a political jab at the Republican-dominated Food & Drug Administration. Although, the numbers do speak for themselves. The agency has been devastated by continuous budget cuts and scandals, so it would not come as a surprise if this is true.

At this stage of medical history, being more vigilant about your diet and lifestyle is of the utmost importance.

No comments: