USA's IOM calls for new FDA standards in evaluating biomarkers and surrogate endpoints in chronic disease

According to a new report from the USA's Institute of Medicine, the Food and Drug Administration relies on crude tools to measure the benefits of drugs, food and supplements, and needs a whole new set of standards. It has therefore recommended that the FDA adopt a consistent scientific framework for biomarker evaluation in order to achieve a rigorous and transparent process to evaluate studies that are presented by companies seeking product approvals.

There are no scientific grounds for using different standards of evidence when evaluating the health benefits of food ingredients and drugs given that both can have significant impacts on people's well-being, said the committee that wrote the report.

Congress should boost FDA's authority