FDA calls for modernization of regulatory science

By Caroline Scott-Thomas

- Last updated on GMT

Related tags: Food safety, Food and drug administration

FDA calls for modernization of regulatory science
The Food and Drug Administration (FDA) has called for modernization of the science used to develop and evaluate the products it regulates, in a "Strategic Plan for Regulatory Science" document – including in implementation of new food safety law.

The plan builds on a paper released by the agency in October last year, in which it outlined the importance of the agency’s efforts to keep its food safety program in step with emerging risks, such as the rapid development of testing methods to ensure the safety of seafood from the Gulf of Mexico after the oil spill there, or monitoring anti-microbial resistant foodborne pathogens.

FDA commissioner Margaret Hamburg said in a statement: "The breadth and scope of FDA's regulatory oversight is extraordinary, touching the lives of every American, through the food they eat, the medicines they take, and the medical devices they use. As new discoveries yield increasingly complex products, this strategic plan ensures that our experts are equipped to make science-based decisions resulting in sound regulatory policy. It positions us to foster innovation through better science without compromising our high safety standard."

The FDA is responsible for overseeing the safety of about 80 percent of the nation’s food supply.

In a dedicated section on food safety, the document concentrates on implementation of the Food Safety Modernization Act, which was signed into law in January.

The agency said that the new law focuses on prevention and risk-based priority setting.

“To effectively implement this new food safety mandate, it is imperative that FDA ensures a strong science infrastructure, clearly identifies its research needs, and collaborates with other public health and research agencies in the Federal government, state government agencies, academia, and private industry,”​ the paper said.

In particular the FDA said it intends to focus on implementing centralized planning and performance measurements; improving information sharing; maintaining ‘mission critical’ science capabilities; and cultivating expert institutional knowledge through training programs.

More information is available on the FDA’s website here: www.fda.gov/regulatoryscience​.

Related topics: R&D, Food safety, Food safety and labeling

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1 comment

Good idea

Posted by Jon Yaffe,

We'll have to see just where this goes. With respect to fundamentally new products, especially genetically modified organisms (GMOs), there is a critical need for such procedural changes as:
1. Increased Objectivity: Testing should performed by unbiased qualified parties (i.e., who do not work for the companies producing the products being tested or have other conflicts of interest regarding the direction of the outcome).
2. Increased comprehensiveness: Minimum standards should be established by the scientific community, to assure that testing adequately examines the impact of these products on the health and reproductive viability of consumers and their offspring, and the environment. Beyond these generic standards, test designs for specific products should be reviewed by the scientific community and approved prior to commencement.
3. Increased Transparency: The FDA, scientific community, and ultimately the public should have access to complete and unfiltered raw data, not just summaries of the research findings as distilled by "interested parties".
Predictably corporations will complain about such guidelines/requirements, but the public and environmental welfare needs to trump concern for profits. Costs to the corporations could and should be offset by having the academic community participate in research design and implementation, so long as the academic community is not co-opted by the financial influence of the corporations whose products they are testing. Government and foundation funding would be a natural means of providing this objectivity - and would be a stimulus for the growth of objective science.

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