Panel Recommends Strengthening FDA Review Processes

In a new report issued by the Institute of Medicine (IOM) and commissioned by the Food and Drug Administration (FDA), researchers recommend that food safety officials utilize stricter scientific standards when using biomarker tests to settle food safety claims. Biomarkers, such as high cholesterol, are used to predict clinical outcomes, such as rate of heart attacks, to expedite safety review processes or when data is difficult to attain. The FDA’s current review practices utilize stricter standards for drugs and medical devices than they do for evaluation of foods and nutritional supplements, which the panel found can create quality control hazards. The IOM panel recommended a framework which the FDA can use to incorporate biomarker data into its reviews, but cautioned that the FDA must also apply the same rigor in its analysis that they use when reviewing pharmaceutical products.

Click here to read the panel’s full report and recommendations.