Markey Urges “Return-Recuse-Review” Approach after Report of Multimillion Dollar Contribution Involving FDA Appointee Studying Chemical BPA  

WASHINGTON, D.C. – Representative Edward J. Markey (D-MA), a senior member of the House Energy and Commerce Committee with oversight over the Food and Drug Administration (FDA), today called on the FDA to fully respond to media reports that an anti-regulation advocate who considers bisphenol A (BPA) to be “perfectly safe” donated $5 million to a research center run by the chairman of a special FDA panel investigating the safety of BPA. The chairman, Dr. Martin Philbert, did not disclose the donation when reporting potential conflicts of interest, according to the Milwaukee Journal Sentinel which broke the story this weekend.

Rep. Markey noted that these revelations represent an apparent or, at minimum, a perceived conflict of interest that will cast doubt on the objectivity of the FDA panel's BPA determination.  In his letter, Rep. Markey urged the FDA to conduct a thorough investigation of the issues raised in the Journal Sentinel report, as well as an overall review of the BPA panel's activities to ensure that its work has not been colored by conflicts of interest.  He also urged the FDA to consider either requiring Dr. Philbert to return the $5 million donation or recuse himself from further participation on the BPA panel.

"In light of these disturbing revelations, the FDA should follow a ‘return-recuse-review' approach to ensure the objectivity of its BPA work.  The agency should either ask Dr. Philbert to return the $5 million gift his research center received from an opponent of BPA regulation or recuse himself from further participation on the BPA panel.  Moreover, the FDA should conduct a thorough review of all of the BPA panel's activities before it makes its determination of BPA's safety to make certain that its assessment has not been colored by any conflicts of interest," said Rep. Markey.

BPA is a chemical used to harden plastics and is associated with a broad spectrum of hazardous effects. Although the FDA preliminarily determined BPA to be safe, its final determination is expected soon. A growing number of scientific studies have shown the wide array of potential health hazards linked to the chemical.  

In June, Rep. Markey introduced legislation, H.R. 6228, to prohibit the use of BPA in all food and beverage containers. In his letter to FDA Commissioner Andrew von Eschenbach, Rep. Markey asked for responses to a series of questions including:

• When did the FDA become aware of this donation and from whom? 
• Should Dr. Philbert have disclosed Mr. Gelman's $5 million donation to the center when it occurred, reportedly in July 2008?  Does such a failure to disclose this information violate FDA policy? 
• If FDA had been aware of this donation prior to making its selection of chairperson to head the BPA panel, would it still have selected Dr. Philbert? 
• Now that FDA is aware of Dr. Philbert's involvement with Mr. Gelman, will it require Dr. Philbert either to return the $5 million his center received from Mr. Gelman or recuse himself from the decision-making process?  If not, why not? 

"The prevalence of BPA in everything from baby bottles to soup cans, coupled with mounting concerns about the effects of BPA on human health, have placed a special importance on the FDA's final determination on the safety of this chemical. As a result, it is all the more crucial for the FDA to investigate this situation immediately and uncover any other extraneous issues that could  influence the panel making this critical safety decision," Rep. Markey said.

A full copy of the letter is available here: http://markey.house.gov/docs/health/bpa_fda_conflict_of_interest_101408.pdf

 
#  #  #