The workshop, co sponsored by Nature journal, the Institute of Food Technologists (IFT), and the Pew Heath Group, brought together more than 80 scientists and and policymakers to develop a shared understanding of the current system FDA uses to assess the hazards of chemicals added to human food and explore opportunities to strengthen that system.
EVALUATING STUDY DESIGN AND DATA FOR REGULATORY DECISIONS
Round 2 of the small group discussions will shift from a narrow focus on study endpoints to the overall study design. This expanded focus will allow us to build on the previous discussions and deal with specific challenges that have been raised about both guideline-based studies and hypothesis-based research. To help focus the discussion, we selected four topics designed to engage participants. They are
FDA’s presentation immediately before this round should help prepare you for this discussion by explaining how it assesses the safety of food additives and makes its regulatory decisions. You may want to review the three documents that FDA provided at the end of this binder as background to the discussion.
The first session will focus on whether the methods to develop doses for nonclinical, guidance-based studies need to be modified on the basis of research indicating low-dose effects.
The second session will focus on the challenge of transparency in both hypothesis-based research and guideline-based studies as well as FDA’s review of the science. Most stakeholders agree that the results of the studies would be more credible and useful if FDA and independent analysts had access to the raw data, laboratory notes and detailed analysis so they could make their own evaluation. But accomplishing this would be a challenge. In both types of studies, independent analysts cannot access the information. FDA gets access only if a study is
The third session will focus on how to ensure that studies evaluated by FDA are reproducible in other laboratories. If the study results are not reproducible, they have limited use in guideline-based studies and should not be the basis of a validated endpoint or toxicity study design. Guideline-based studies comply with GLP standards to provide assurance to FDA that the results are reproducible. Hypothesis-based researchers rely on their peers to evaluate their publications and attempt to reproduce their data. However, funding for study replication is limited.
The fourth session moves beyond the three key issues and takes a broader look at how FDA can make better use of hypothesis-based research directly in its regulatory decisions. FDA often relies on this type of research for clinical studies, epidemiological studies or studies that expand on guideline-based studies. This session is designed to help researchers better understand FDA’s needs and to help FDA better understand researchers’ capabilities.
Read Full Section: Small Group Discussion Round 2 (PDF)
A recent article by Pew experts concludes that the science the U.S. Food and Drug Administration (FDA) uses to assess the safety of food additives has not kept pace with recent scientific developments, and the agency should review and retool its approach to making decisions about the safety of chemicals used in food and packaging in the United States.
More info"Amid growing public concern over the safety of additives in products ranging from caffeinated energy drinks to industrial chemicals in food containers and water bottles, the U.S. Food and Drug Administration is under pressure to reexamine its rules, and there are signs it may do so."
More infoThe complexity of our food supply and the oversight of its safety raise fundamental questions about what we eat — some of which were answered for the first time in "Navigating the U.S. Food Additive Regulatory Program," an analysis undertaken by Pew and published in the peer-reviewed journal, Comprehensive Reviews in Food Science and Food Safety. The following "frequently asked questions" summarize the findings and conclusions of this article.
More infoFrom oil in Gatorade to the amount of caffeine and other stimulants in energy drinks and the so-called "pink slime" found in beef, previously unnoticed ingredients are coming under scrutiny as health-conscious consumers demand more information about what they eat and drink, and sometimes go public via social networking and the Internet.
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