FDA needs new tools to check food, drugs: experts

The U.S. Food and Drug Administration is stuck using crude tools to measure the benefits of food, drugs and supplements and needs a whole new set of standards, a panel of experts said on Wednesday.

Relying on so-called biomarkers is confusing the entire process of drug development, the public and doctors alike, they said.

The FDA also needs to use the same strict standards for assessing health claims of food and supplements as it does for drugs, said the panel appointed by the Institute of Medicine, which advises the federal government.

The committee recommended a new framework the FDA could use for judging studies that companies provide to support health and safety claims for their products.

“Congress may need to strengthen FDA authority to accomplish this goal,” the institute’s report reads.

The Obama administration is tackling the issue of food and health on several fronts. On Tuesday, first lady Michelle Obama released a 70-point plan for reducing childhood obesity, including a call for marketing healthier food.

The committee’s report focuses on biomarkers, which can include measures as simple as temperature. Common biomarkers include levels of cholesterol and blood sugar.

Drugs to treat diabetes are often approved simply because they lower blood sugar and heart drugs can win FDA approval because they lower cholesterol. But the report said this does not mean they make patients healthier.

“This is a groundbreaking report that tells us we should really think carefully about the use of biomarkers and surrogates,” Dr. Harlan Krumholz, a cardiologist at Yale University who sat on the panel, said in a telephone interview.

One example: GlaxoSmithKline Plc’s diabetes drug Avandia lowers blood sugar well but also raises the risk of heart failure and heart attack.

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Krumholz said he was stunned to learn that tumor size is used as a surrogate to judge whether a cancer drug is working, even though the shrinking of tumors does not necessarily help cancer patients live any longer.

Another example would be breakfast cereals that claim 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.”

The Center for Science in the Public Interest, a consumer group, welcomed the report, which was sponsored by the FDA.

“Right now the supermarket is a jungle of unsupported health-related claims,” the group said in a statement.

Committee chairman John Ball of the American Society for Clinical Pathology said consumers often assume the FDA regulates food and supplements in the same way it does drugs.

The FDA is also hobbled by the Dietary Supplement and Health Education Act, or DSHEA, the report says.

“Under DSHEA, dietary supplements are broadly presumed to be safe, and the FDA does not have the authority to require dietary supplements to be approved for safety and efficacy before they enter the market,” it reads.

“Because of the regulatory framework for dietary supplements, the FDA has little information about the safety and effectiveness of dietary supplements.”

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