Institute of Medicine Recommends FDA Revisit Biomarker Standards

The Institute of Medicine (IOM; Washington, DC) has released a report urging FDA to standardize its methods for validating biomarkers used in scientific studies. IOM says that right now, FDA is hampered in its ability to evaluate proposed health claims because it lacks a process for validating biomarkers.

The report, 'Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease,' indicates that while biomarkers do not always fully predict health outcomes, they are important to health care practitioners, regulators, and consumers in gathering information about available foods, supplements, drugs, and medical devices.

In its report, the IOM calls for FDA to make several changes to its regulatory framework surrounding biomarkers, including creating an expert panel to assess the use of biomarkers and biomarker tests. Another proposed change is to establish a large-scale data collection service to facilitate the sharing of scientific data and a better understanding of how biomarkers are being used in clinical studies.

Many in the dietary supplements industry have indicated their support for measures to encourage FDA to establish more validated biomarkers. Several also took issue with a large portion of IOM's report, however, which instead of focusing on the issue of biomarkers turned to discussing standards of evidence in evaluating health claims for foods, supplements, and drugs. 'The IOM committee seems to have veered off course of their target,' reads a press release from the the Natural Products Association (Washington, DC), last week. 'While the work on the biomarkers is of value, it seems unwise for [the IOM] to present such broad statements regarding regulatory authority of the FDA on food claims, which is neither their expertise nor within [the IOM...s] scope"'

To read a detailed briefing of the report from the Institute of Medicine, click here.