Grassley asks the FDA to account for studies it used in assessing BPA

WASHINGTON --- Senator Chuck Grassley is asking the Commissioner of the Food and
Drug Administration to describe how the agency selected the studies it is using to assess the
safety of the chemical Bisphenol A, or BPA.

An FDA panel is scheduled to meet today to consider the FDA’s findings to date
regarding this component of plastic containers for food and beverages. Earlier this month, a
Dow Jones news story reported that studies of BPA funded by the National Institutes of Health
were largely not considered by the FDA. A study in today’s Journal of the American Medical
Association describes the negative health effects of BPA.

Here is the text of Grassley’s letter to FDA Commissioner Andrew von Eschenbach.

The Honorable Andrew C. von Eschenbach, M.D.
Commissioner
U.S. Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857

Dear Commissioner von Eschenbach:

As Ranking Member of the Committee on Finance (Committee), I have a responsibility
to the more than 80 million Americans who receive health care coverage under the Medicare and
Medicaid programs to oversee the proper administration of these programs and ensure that
taxpayer and beneficiary dollars are appropriately spent. This responsibility includes oversight
into the actions of executive branch agencies, including the activities of the Food and Drug
Administration (FDA).

Today, the Journal of the American Medical Association (JAMA) released a study which
claims to find an association between the chemical Bisphenol A (BPA) and a host of other health
effects including increased prevalence of cardiovascular disease, diabetes, and liver enzyme
abnormalities.[1] This study follows a report released on September 3, 2008, by the National
Toxicology Program (NTP), which is a part of the National Institutes of Health (NIH).

According the NTP’s report on BPA, there is some concern that low doses of BPA may affect
development of the brain. Further, the NTP report voiced concern that BPA may cause
behavioral effects in fetuses and children.[2] These findings are important because BPA is used
in plastics that serve as storage for food and beverages.

I understand that later today, FDA is holding a panel on the possible health effects of
BPA. This panel will peer-review and discuss a draft risk assessment on BPA that FDA released
in August 2008.[3] But according to news reports, this draft risk assessment only contains studies
that were funded by industry and ignores many studies funded by the NIH.[4]

In fact, Jerry Heindel, the scientific program administrator for the National Institutes of
Environmental Health Sciences told a reporter that the studies in FDA’s risk assessment were old
fashioned and did not go far enough to capture the effects of BPA.[5]

I am concerned that the FDA by its actions is determining that NIH-funded studies do not
merit a review by the FDA safety panel on BPA. Further, I am concerned that the FDA’s draft
risk assessment does not appear to list the name of the authors who wrote the assessment.
Accordingly, please respond to the following questions and request for documents. In
responding, please repeat the enumerated request followed by the appropriate answer.

1) Why did FDA decide not to include NIH funded studies for this draft risk assessment on
BPA?

2) According to Dow Jones, FDA is only allowing studies that rely on Good Laboratory
Practices in the draft risk assessment. This means that NIH-funded studies were not
allowed. Does FDA allow studies that do not use Good Laboratory Practices when
making decisions on drug safety?

3) Please provide the names and titles of any individuals who worked on drafting the BPA
risk assessment.

4) Please provide all internal communications regarding FDA’s draft risk assessment on
BPA, including drafts.

5) Please provide all communications and documents received by the FDA from the
American Chemistry Council and/or producers of Bisphenol A regarding FDA draft risk
assessment on BPA.

Thank you for your cooperation and attention to this important matter. Please respond to
the questions and requests set forth in this letter by no later than September 30, 2008.

Sincerely,

Charles E. Grassley
United States Senator
Ranking Member of the Committee on Finance

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[1] David Melzer et. al. “Association of Urinary Bisphenol A Concentration with Medical Disorders and Laboratory
Disorders in Adults” JAMA, September 17, 2008.
[2] Jared A. Favole “FDA to Face Public Upbraiding Over Ingredient in Plastic,” Dow Jones Newswires, September
11, 2008.
[3] Food and Drug Administration, “Draft Risk Assessment of Bisphenol A for Use in Food Contact Applications,”
August 14, 2008.
[4] Jared A. Favole “FDA to Face Public Upbraiding Over Ingredient in Plastic,” Dow Jones Newswires, September
11, 2008.
[5] Id.

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