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US FDA Says Chemical Panel Chief did Nothing Wrong

Source: Reuters
30/10/2008

Washington, Oct 30 - The U.S. Food and Drug Administration on Wednesday cleared the head of an advisory panel that examined the safety of a chemical used in many plastic products of allegations of conflict of interest.

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The action came a day after the panel issued a report saying the FDA failed to consider studies calling into question the safety of bisphenol A, or BPA, when it issued a draft conclusion in August maintaining that the chemical is safe.

The controversy involved Martin Philbert, a University of Michigan professor serving as chairman of an FDA panel of outside experts who reviewed the safety of BPA, used for decades to harden plastic in products including baby bottles.

U.S. lawmakers and activist groups had accused Philbert of acting improperly by failing to disclose that a research center he headed accepted a $5 million donation from a retired medical equipment maker who has argued BPA is "perfectly safe."

Randall Lutter, deputy commissioner for policy, said in a letter that an FDA investigation found Philbert had done nothing wrong, but "it might be wise" if he refrains from voting when an FDA board considers the panel report on Friday.

The advisory panel's report concluded "the margins of safety defined by FDA as 'adequate' are, in fact, inadequate."

The FDA issued a statement reiterating its view that "based on all available evidence" current levels of exposure to BPA through food packaging do not pose an immediate health risk to the public, including infants and babies.

"We need to get that clear -- we did not ignore studies. We looked at all the studies," Norris Alderson, FDA associate commissioner for science, said in a telephone interview.

"The committee gave us valuable guidance on how we can improve our assessment using the current data. But they did not say in any way that I can find that there is an immediate health risk," Alderson said.

Some U.S. lawmakers said the advisory panel's report is more evidence the FDA has mishandled its assessment of BPA.

BPA is used in many food and beverage containers, the coating of food cans and some medical devices. It mimics the hormone estrogen in the body. People consume it when it leaches from plastic into baby formula, water or food in a container.

The panel urged the agency to take into account other animal studies that have found health concerns and studies published since the draft assessment was made.

U.S. government toxicologists at the National Institutes of Health this year concluded BPA presents "some concern" for harmful effects on development of the prostate and brain and for behavioral changes in fetuses, infants and children.

A study by British researchers published in September showed that people with the highest levels of BPA in their body were much more likely to have heart disease, diabetes and liver-enzyme abnormalities than those with the lowest levels.

Canada said this month it will move to limit sales of baby bottles made with BPA due to health concerns.

Environmental activists and some U.S. lawmakers have accused the FDA of relying too heavily on two industry-funded animal studies to dismiss safety concerns about BPA.

Laura Tarantino of the FDA's Center for Food Safety and Applied Nutrition said those studies "were the best we had" in guiding safety conclusions on BPA. She said it is unlikely the FDA would make its final conclusion on BPA's safety this year.



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