In addition, the report calls on Congress to boost the agency's authority to require further studies of drugs and devices after they are approved if their approval is based on studies using biomarkers as surrogate clinical outcomes. And Congress should give FDA the authority to conduct studies of how well consumers understand food and supplement health claims and require manufacturers to make changes if needed to promote greater clarity.
"Many people naturally assume that the claims made for foods and nutritional supplements have the same degree of scientific grounding as those for medications, and this committee thinks that should in fact be the case," said committee chair John Ball, executive vice president, American Society for Clinical Pathology, Chicago. "Without changes in the way biomarkers are used and assessed, however, health care providers, regulators, and consumers will not be able to reliably collect or judge information to support claims."
The proposed framework entails validating that a biomarker can be accurately measured, ensuring that it is associated with the clinical outcome of concern, and confirming that it is appropriate for the proposed use. Committee members demonstrated the kinds of information and lessons the framework can provide by doing several case studies, looking at tumor size as a biomarker for cancer, blood level of beta-carotene as a surrogate for cancer and cardiovascular disease risk, and cholesterol level as an indicator of heart disease, among others.
The report calls for Congress to enhance FDA's abilities to study how health-related information can be communicated more effectively to consumers to help them better understand the science behind claims they see on packaging. The typical consumer is not aware that claims for food ingredients and supplements are often made based on studies using biomarkers instead of actual health outc
|Contact: Christine Stencel|
National Academy of Sciences