In his presentation at the Institute of Medicine (IOM)-hosted event, Andrew Shao, CRN’s senior vice president of scientific and regulatory affairs, said the limited list of biomarkers – or surrogate endpoints – meant fewer possible health claims.
“CRN has commented to both FDA and NIH (both Office of Dietary Supplements and National Center for Complementary and Alternative Medicine) in the past about the urgent need for additional biomarkers as surrogate endpoints,” Shao told the workshop.
The workshop follows on from an IOM report on the same subject published last month. NutraIngredients-USA’s coverage of that report can be found here.
Framework
The fact that the IOM and others are even considering a formal framework to establish biomarkers is highlighted by Shao as being a positive step, as before there were none.
“The lists of biomarkers validated as surrogate endpoints for disease and as markers of nutrient exposure (i.e. status) are disappointingly short and have been for some time. We hope that with the implementation of this new framework, those lists will eventually grow, although we recognize that this is a long and complicated process.”
Shao said a formal biomarker evaluation process would boost product development because companies would know the research they conduct would better find use in a commercial sense and in line with health claims and public health recommendations.
“As far as consumer understanding, that will depend on whether and to what extent efforts are undertaken to build consumer awareness. In the end, consumers are not so much interested in the biomarker as they are the clinical endpoint that it represents.”
But Shao questioned whether the resources were available to develop any recommendations about biomarkers.
He also questioned how appropriate it was to apply the same degree of scientific rigour in evaluating biomarkers across drugs, medical devices, biologics, or foods and dietary supplements.
Inconsistencies and nonsense
Inconsistencies existed in the IOM report, he said, as while advocating a one-size-fits-all approach, it also acknowledged different regulatory systems existed, and that, “legislation may be required to revise the science-based standards and regulatory processes for these non-drug products.”
He added: “Biomarkers are not only important as surrogates for clinical endpoints but also essential in the assessment of nutrient exposure, which are not only used to inform decisions on health claims, but also for the Dietary Reference Intakes and statements of dietary guidance. The notion that the scientific and regulatory frameworks for these public health recommendations should be identical for those used in the drug approval process is nonsensical."
Shao confirmed criticism of the IOM for entering into the regulatory debate when it was, “outside the scope of the expertise of the IOM Committee and their mandate”.