FDA Faulted On Budget Projections

The U.S. Food and Drug Administration (FDA), responsible for much of this country’s <"http://www.yourlawyer.com/practice_areas/food_poisoning">food safety, has been routinely criticized for lax oversight on a variety of issues. Now, the Government Accountability Office (GAO) has said that the FDA does not have “the data to develop a complete and reliable estimate of the resources it needs,” quoted the Associated Press (AP).

Issues with the FDA have included the recent historic Salmonella outbreak linked to the Peanut Corporation of America (PCA) that sickened over 900 people and was linked to at least nine deaths; 46 states were involved and over 3,000 products were recalled, making it the largest food recall in American history.

Although a number of other deadly and widespread outbreaks have plagued the nation in recent years, it was the disgusting conditions and ongoing negligence involved in the PCA debacle that forced serious food safety reform. The scandals revealed during the outbreak highlighted myriad problems with current food safety processes and prompted attention from President Obama, said the Washington Post previously; the president continues to take steps to correct the issues hampering the battered agency and has called for an FDA and food safety system overhaul.

According to the AP, the food, drugs, and goods that the FDA regulates comprise almost one-quarter of the U.S. economy, but the agency remains unable to determine its fiscal needs, citing congressional investigators. One of the problems, noted the GAO, is that the agency dumps money into new product approval, but does not exhibit the same financial enthusiasm for tracking existing products, the AP reported.

The GAO reviewed agency funding and workload in the areas of drug, devices and vaccines, and biologics at the FDA from fiscal years 2004-2008, according to Dow Jones.

Dow Jones reported that another problem revealed by the GAO involves inadequate staffing at the FDA, which is unable to track adverse-event reporting, adding that while FDA funding has increased over the past five years, so, too, have the agency’s responsibilities. Such reporting enables the FDA to track safety problems with drugs and medial devices, said Dow Jones.

The GAO found that adverse event reports were up; however, the FDA was unable to offer details on how many reports were received. “Without such information, FDA cannot develop complete and reliable estimates of its resources needs,” the GAO said, quoted Dow Jones. The reports number well into the hundreds of thousands for drug- and medical device-related adverse events but, reported Dow Jones, the FDA said that it receives “substantially” more such reports than its staff can review and its current reporting systems do not allow tracking of whether reports have received review.

The agency was long accused of being corrupt and for a wide variety of issues, conflicts, and failures. The AP pointed out that the report released yesterday is just the most recent in the array such documents, which have highlighted the issues at the FDA, noting the debacle with Vioxx, the painkiller linked to heart attacks and other cardiac issues; contaminated heparin imported from China; food borne illness catastrophes, such as the Salmonella-contaminated peppers from Mexico that made headlines last summer; and a failure to adequately inspect drug manufacturing plants.

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