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FDA Looking At Medical Devices, Drugs Containing BPA

Oct 16, 2008 | Parker Waichman LLP

Yesterday, the US Food and Drug Administration (FDA) announced that it is seeking assistance identifying medical devices, drugs, and other products it regulates that contain Bisphenol A (BPA).  The FDA is also reviewing a financial conflict of interest issue concerning a prominent toxicologist leading its panel reviewing BPA’s safety.  Some lawmakers say the controversy could minimize the credibility of the FDA’s BPA assessment while an FDA official argued that nothing improper occurred.

BPA is used extensively in food and drink containers and baby bottles; is found in drinking water, dental sealants, and household dust; and can be found in the systems of nearly every American.  In recent months, pressure has been mounting for government and corporate action, partly because BPA is so ubiquitous it is nearly impossible to avoid.  BPA, which has been linked to cancer, heart disease, obesity, liver function abnormalities, hormonal irregularities, diabetes, and interactions with chemotherapy is one of the world's highest production volume chemicals, with over 6.4 billion pounds produced in 2003 and annual increases in demand of between six-10 percent.

The FDA has long been criticized by consumers, researchers, and lawmakers for its unwavering stance—in the face of enormous opposition—that BPA is safe at current levels.  While over 100 studies point to BPA’s safety issues, the FDA continues to rely on two industry-funded studies, prompting researchers to argue that the FDA is ignoring most of the independent research indicating BPA may lead to human developmental health problems.

Meanwhile, the House Energy and Commerce Committee has been investigating the FDA's handling of the BPA issue and Tuesday said the FDA ignored an obvious conflict of interest involving University of Michigan professor Martin Philbert.  Philbert heads an FDA advisory panel that is presumably delivering an independent BPA risk assessment; however, the independence of that assessment is now in question.  It seems Dr. Philbert is also acting director of a risk science center at Michigan that received a $5 million pledge this summer from retired medical supply manufacturer Charles Gelman, a university alumnus who ran a manufacturing company that was involved in a pollution case in the 1980s with Michigan authorities.  Gelman is openly skeptical of BPA's risks. Philbert did not disclose the donation when the FDA reviewed his finances in preparation for his role in the advisory panel.

Government rules require outside advisers to disclose conflicts, and the FDA bars experts with a financial interest in a company from voting on recommendations that may affect it.  "That said, we have no reason to believe that Dr. Philbert has done anything other than act in good faith on this matter," FDA spokesman Mike Herndon said.  But, many wonder if such a donation can bias one’s judgment.

The FDA said it is seeking details on what medical devices with direct contact with tissue, blood, and skin contain BPA, such as implants, catheters, and most dental devices. The FDA is also looking for information on products with BPA that have indirect contact with patients, such as blood pathway and respiratory tubing circuit components and IVs.

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