Congress Threatens FDA With Subpoenas on Approval of Baby Formula Contaminant
The full text of the Dingell/Stupak Letter to Commissioner von Eschenbach is below and can be found at the Committee’s website: http://energycommerce.house.gov/Press_110/110nr245.shtml
Tuesday, April 8, 2008
The Honorable Andrew von Eschenbach, M.D.
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
Dear Dr. von Eschenbach:
Under Rules X and XI of the Rules of the U.S. House of Representatives, the Committee on Energy and Commerce and its Subcommittee on Oversight and Investigations are investigating the use of the chemical Bisphenol A (BPA), particularly in products intended for use by infants and children.
Thank you for your February 25, 2008, response to our initial letter. However, based on your response, it appears that the Food and Drug Administration’s (FDA) position on BPA’s safety is entirely dependent on two studies, both of which are funded by the American Plastics Council, and one of which has not been published or peer-reviewed. Given that there are dozens of published, peer-reviewed studies related to BPA, your development of critical public health policy in this manner, especially as related to infants and children, seems highly questionable.
Therefore, we ask that you please respond to the following:
- Please provide in writing the names of those who specifically made the decision to base FDA’s assessment of BPA’s safety on these two studies;
- Please provide in writing the names of those who specifically made the determination of BPA’s safety based on these two studies; and
- Please describe the process by which FDA may reconsider their decision regarding the safety of BPA.
Finally, in your letter you indicate that you will provide copies of these two studies and their review memoranda as part of the response to our request. We have not yet received these studies or their review memoranda. Please provide them forthwith; otherwise, we may consider issuing a subpoena for these records.
Please deliver copies of the requested records to the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, Room 316, Ford House Office Building, no later than two weeks from the date of this letter. Please note that for the purpose of responding to this request, the terms “record” and “relating” should be interpreted in accordance with the attachment to this letter. After review of the records, we may require additional records and/or staff interviews with FDA staff.
Thank you for your prompt attention to this matter.
s/John D. Dingell
Committee on Energy and Commerce
s/Bart Stupak Chairman
Subcommittee on Oversight and Investigations
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