FDA could do better: experts - Macleans.ca

FDA could do better: experts

A new set of standards is needed, they say


The U.S. Food and Drug Administration is hampered by the crude tools it uses to examine the benefits of food, drugs and supplements, according to a panel of experts who are calling for an entirely new set of standards, Reuters reports. Its standards for assessing the health claims of food and supplements are not as strict as those used for drugs, which is a mistake, said the panel appointed by the Institute of Medicine, which advises the federal government. It recommended a new framework to compare companies’ studies to support their health and safety claims. In the report, it noted that relying on so-called biomarkers has confused the process. These can include temperature, levels of cholesterol, and blood sugar. But while drugs used to treat diabetes, for example, are often approved just because they lower blood sugar, this doesn’t necessarily mean they make patients healthier, the report said. For example, GlaxoSmithKline Plc’s diabetes drug Avandia lowers blood sugar, but raises the risk of heart failure and heart attack. “Congress may need to strengthen FDA authority to accomplish this goal,” the report says.


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