According to a panel of experts Wednesday, the US Food and Drug Administration (FDA) needs to exchange its crude tools for measuring the benefits of food, drugs and supplements for a whole set of new standards.
The agency’s reliance on so-called biomarkers confuses the entire drug process development for both the public and doctors alike.
The panel appointed by the Institute of Medicine advising the federal government said the FDA should use the same strict standards for assessing health claims of food and supplements as for drugs.
The committee recommended a new framework that companies provide for supporting the health and safety claims of their products, to be used by FDA for judging studies.
According to the institute’s report, Congress needs to strengthen FDA authority to accomplish this goal.
With the Obama administration tackling the issue of food and health on several fronts, first lady Michelle Obama released a 70-point plan for reducing childhood obesity Tuesday, calling for marketing healthier food.
The committee’s report focuses on biomarkers that can include measures as simple as temperature, including common biomarkers that include levels of cholesterol and blood sugar.
According to the report, FDA simply approves a drug that treats diabetes simply because it lowers blood sugar, while heart drugs get approved for lowering cholesterol. However, this does not mean they improve the health of the patients.
Take the example of GlaxoSmithKline Plc’s drug Avandia which lowers blood sugar levels in diabetics, while raising the risk of heart failure and heart attack.
Another example is breakfast cereals claiming to provide immune-boosting vitamins and minerals or to lower cholesterol.
"A lot of people probably fed Cocoa Krispies to their kids this winter thinking it would protect them from flu," Krumholz said. "What we say is there is a Wild West out there with regard to food."
Consumer Group, the Centre for Science in the Public Interest welcomed the report.
The report says FDA is hobbled by the Dietary Supplement and Health Education Act (DSHEA), uncer which dietary supplements are broadly presumed to be safe.
Lacing the authority to require dietary supplements to be approved for safety and efficacy before they enter the market, the FDA has little information about the safety and effectiveness of dietary supplements.
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