FDA Releases Draft Guidance on Health Claims Approval Process

WASHINGTON—FDA published, "Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims", which updates the agency's approach to the review of the publicly available scientific evidence for significant scientific agreement (SSA) health claims and qualified health claims.

The various steps in the evidence-based review system include: identifying studies that evaluate the substance-disease relationship; identifying surrogate endpoints for disease risk; evaluating human studies to determine whether scientific conclusions can be drawn about the substance-disease relationship; assessing the methodological quality of each human study from which scientific conclusions about substance-disease relationship can be drawn; and evaluating the totality of scientific evidence.

In the guidance, FDA calls randomized, controlled intervention studies (RCTs) the strongest evidence on whether there is a relationship between substance and disease. However it cautions against extrapolating results from a study on a specific disease population to cover a related, but significantly different, population. On observational studies, FDA is less enthusiastic, faulting them for lack of control and frequent reliance on self-reporting of food intake. The guidance outlines the pros and cons of various types of observational studies, which the agency states can identify possible connections between substance and disease but often fall short of providing convincing evidence of cause and effect. FDA will consider observational studies in support of health claim petitions.

FDA also provides examples of the surrogate endpoints it will accept in health claim petitions, including: serum low-density lipoprotein (LDL) cholesterol concentration, total serum cholesterol concentration and blood pressure for cardiovascular disease; bone mineral density for osteoporosis; adenomatous colon polyps for colon cancer; and elevated blood sugar concentrations and insulin resistance for type 2 diabetes. The agency specifically noted an acceptable endpoint involved in a single pathway cannot be used for a substance that affects the disease from a different pathway.

As part of its evidence-based review, FDA noted certain critical elements of a study—design, data collection and data analysis—can be flawed, making it impossible to draw a scientific conclusion. It warns: “FDA does not intend to use studies from which it cannot draw any scientific conclusions about the substance-disease relationship and plans to eliminate such studies from further review.” It further lists examples of questions it will use in reviewing various studies—intervention, observational, etc.—for certain scientific conclusions.

For studies making the grade, FDA will assign a high, moderate or low quality rating, based largely on the study design, data collection, data analysis, outcome measured and study population characteristics. The guidance explains the criteria behind each rating and provides examples of how it will judge those study factors.

In the end, FDA’s evaluation will consider the study type (e.g., intervention, prospective cohort, case-control, cross-sectional); methodological quality previously assigned; quantity of evidence (number of the various types of studies and sample sizes); relevance of the body of scientific evidence to the U.S. population or target subgroup; whether study results supporting the proposed claim have been replicated; and overall consistency of the total body of evidence. FDA will use this “totality of scientific evidence” to determine whether studies submitted in a claim meet the SSA standard or are credible to support a qualified health claim for a substance-disease relationship.

FDA also stated it may revisit health claim petitions on its own initiative or in response to a petitioner. New evidence related to a health claim or petition for a claim will also be considered, with changes made to the petition evaluation as new evidence warrants.

Comments on this draft will be accepted until Sept. 4, 2007.

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