The FDA has begun taking steps to shore up the science underpinning its regulatory actions, but gaps in scientific information have hampered FDA’s oversight of food labeling, fresh produce, and dietary supplements, GAO has said.
The FDA is responsible for ensuring the safety of roughly 80 percent of the US food supply, valued at about $466 billion annually, and in 2007 the FDA Science Board reported that science at FDA suffers from serious deficiencies.
Further, a GAO survey of FDA managers found that 67 percent felt that updated scientific technologies or other tools would greatly help them to contribute to FDA’s goals and responsibilities, but just 36 percent said the FDA was making great progress in keeping pace with scientific advances.
Some managers have stressed the need to increase and stabilize funding, recruit and retain top scientists, and make decisions on the basis of scientific evidence, according to GAO-10-182R.
It said however that the agency has begun to address selected Science Board recommendations.
For example, in 2008 it created the Office of Chief Scientist and, in May 2009, it added more responsibilities to the office to signal a new emphasis on regulatory science.
A new FDA computer tool – PREDICT — is also designed to improve its risk-based import screening efforts by analyzing food shipments using criteria that include a product’s inherent food safety risk and the importer’s violation history, among other things, to estimate each shipment’s risk, the report said.
It added that FDA has also developed a draft performance measurement plan for evaluating the effectiveness of such a risk-based approach.
