More on the FDA

More testimony about the FDA today from the GAO before the House Energy and Commerce Committee. From the report by Lisa Shames of GAO:

Changing demographics and consumption patterns underscore the urgency for effective food safety oversight. According to FDA, shifting demographics mean that more of the U.S. population is, and increasingly will be, susceptible to foodborne illnesses. The risk of severe and life-threatening symptoms from infections caused by foodborne pathogens is higher for older adults, young children, pregnant women, and immune compromised individuals. According to FDA, these groups make up about 20 to 25 percent of the U.S. population. In addition, we are increasingly eating foods that are consumed raw or with minimal processing and often associated with foodborne illness. For example, according to the U.S. Department of Agriculture (USDA), leafy greens such as spinach, are the category of produce most likely to be associated with an outbreak, and the average consumer ate 2.4 pounds of fresh spinach in 2005—a 180 percent increase over 1992.

Later, on the FDA's shortcomings.....

Subsequently, FDA’s Science Board, an advisory board to the agency, released a report titled, FDA Science and Mission at Risk. This report, which is the focus of today’s hearing, concluded that FDA is not positioned to meet current or emerging regulatory needs, and stated that FDA does not have the capacity, such as staffing and technology, to ensure the safety of the nation’s food supply. In addition, the report found that FDA’s ability to provide its basic food system inspection, enforcement, and rulemaking functions is severely eroded, as is its ability to respond to outbreaks of foodborne illnesses in a timely manner and to develop and keep pace with the science needed to prevent food safety problems. The report stated that the system cannot be fixed using available resources, and its primary food safety recommendation was that FDA needs additional resources to fulfill its regulatory mandate.

A summary...

FDA’s Food Protection Plan also proposes some positive first steps intended to enhance its oversight of food safety. Specifically, FDA requests authority to order food safety recalls and issue additional preventive controls for high-risk foods, both of which GAO has previously recommended. However, more specific information about its strategies and the resources FDA needs to implement the plan would facilitate congressional oversight. FDA officials acknowledge that implementing the Food Protection Plan will require additional resources. Without a clear description of resources and strategies, it will be difficult for Congress to assess the likelihood of the plan’s success in achieving its intended results.

TK; What seems to be lacking is an Administration plan for more resources for FDA. Here is a comment from the office of Rep. Rosa DeLauro.

“The latest Government Accountability Office report provides yet additional evidence that the Food and Drug Administration is failing its mission to protect the public health.
“Congress alone cannot resolve the myriad problems facing the FDA. Last year, Congress attempted to increase FDA funding significantly, but the proposal was rejected by the Administration. If we are to avoid a repeat of last year’s budget battle, Congress will need the Administration to acknowledge the severity of the problems at FDA and recognize that substantial help is necessary in order to restore consumer confidence in our food and drug safety systems. “Next week the President will release his budget request for the coming year, and it is my hope that the blueprint will include a strong funding proposal for the FDA. “There also needs to be recognition by the Administration that current problems at FDA are very extensive and will require more than just an increase in funding. The existing culture at the FDA that has allowed political and corporate interests to permeate the decision-making process at the expense of irrefutable science is a critical concern that increased funding will not solve. “We need to ensure that the inspectors are not hampered by a lack of resources and outdated technology so that the agency can begin to make up for years of neglect and take the steps necessary toward restoring the FDA to the gold standard for which it was once known. This is not a partisan issue, but one that requires working together across party lines.”