We've been keeping an eye out for the FDA's expert task force review of their own draft report on bisphenol-A (BPA; for more posts see here, here, here, here, here for other BPA posts). We previously reported to you the concern that the (outside) chair of that expert panel had a risk assessment institute at the University of Michigan that was the recipient of a large gift from one of the most vociferous proponents of BPA's safety and an ardent anti-regulatory ideologue. Whether it was a result of "working the refs" or a straightforward judgment, the panel has returned its report, concurring with the critics of the FDA draft:
Health regulators failed to properly assess the potential safety risks posed by the chemical bisphenol A, according to a report by a panel of U.S. independent scientific advisers.
The staff of the U.S. Food and Drug Administration failed to provide "reasonable and appropriate scientific support" for its finding that the public wasn't at risk from bisphenol A, or BPA, a chemical linked in some studies to diabetes and developmental changes in children, the report released today found.
The rebuke widens a dispute among U.S. government scientists over the risks posed by BPA, which has been used for decades to help stiffen plastic for baby bottles and food- storage containers. The FDA said in August that the chemical is safe at current exposure levels, prompting criticism from consumer groups and lawmakers. The finding conflicted with a separate report from the National Toxicology Program that found a risk to children. (David Olmos, Bloomberg)
The task force goes on to detail how FDA failed to take into account the most current scientific information, relying instead on outdated industry studies that were decades old, on the grounds that they used official FDA guidelines and methods. The draft report is scheduled to go to the full FDA Scientific Board October 31 (Happy Halloween!), where it will be discussed at a public meeting. Presumably the critical task force report will be part of the public record.
This latest rebuke is yet another awkward embarrassment for a broken agency . It's response?
The FDA agrees that, due to the uncertainties raised in some studies relating to the potential effects of low dose exposure to bisphenol A, additional research would be valuable. The FDA is already moving forward with planned research to address the potential low dose effects of bisphenol A, and we will carefully evaluate the findings of these studies. (FDA Statement)
Shouldn't they have done this work before they went ahead and gave BPA the "all clear"?
Echoing the task force's report, the authors of this recent paper (http://www.ehponline.org/docs/2008/0800173/abstract.html) argue that the FDA used faulty criteria in selecting the studies to be included in their evaluation.
... with fewer than 500 import inspectors and computer systems so old that repairmen must be called out of retirement to fix them, the agency is increasingly beset by a sense of futility.
Even the F.D.A.'s staunchest defenders now acknowledge that something is terribly wrong. Among them is Peter Barton Hutt, who served as the agencys general counsel during the Nixon administration and is widely considered the dean of the F.D.A. bar in Washington. Ive interviewed Hutt dozens of times over the years, and he has always defended the F.D.A. No more. "This is a fundamentally broken agency," Hutt told me earlier this year, "and it needs to be repaired."