Submitted in response to FDA meeting to discuss updates regarding the continued assessment of BPA in FDA-regulated products
August 18, 2009
Good afternoon. My name is Stephanie Drahan; I am representing the Association of Reproductive Health Professionals (ARHP).
ARHP was founded in 1963 as a multidisciplinary professional association, and our membership is composed of over 12,000 reproductive health professionals who provide direct services, conduct reproductive research, or influence policy. ARHP is offering comments today because we value evidence-based science and serve as the translating interface between cutting edge science and reproductive aged consumers.
On behalf of ARHP and its members, I thank Dr. McNeil and the Science Board for the opportunity to speak on the topic of Bisphenol A (BPA) use in FDA-regulated products. ARHP is encouraged to see that the Science Board and FDA take BPA-associated risks seriously, and are continuing to investigate this area. The subcommittee on BPA completed important work last year, and it is our hope that the Science Board can continue to build upon last year’s recommendations.
History and science make clear that substances once considered safe, such as tobacco, alcohol and mercury, have later been shown to cause harm to pregnant women and their future children. Research informs us that a critical window of exposure may have much to do with what effect a harmful agent may later play in the woman’s health or that of her child.
As a reproductive health issue, it is important for health care professionals, as well as women and families to have state-of-the-art recommendations so women can plan their pregnancies appropriately and assume the healthiest lifestyle—before they even know they are pregnant.
As the Science Board convenes to asses the use of BPA in medical products, ARHP urges you to:
- Take into account all existing research on health effects of BPA to make a final determination about whether or not it is safe.
- Let any action the FDA takes with regard to BPA be driven by the most up to date scientific evidence. If definitive proof of safety cannot be determined, opt for precaution.
When a chemical, such as BPA, raises threats of harm to public health or the environment, precautionary measures should be taken even if cause and effect relationships are not fully established scientifically. In the face of scientific uncertainty and credible threats of harm, ARHP supports preventative action to decrease overall BPA exposure. ARHP and its members believe that it is the responsibility of our regulatory agencies, like the FDA, to protect people, especially women of childbearing age, children and adolescents from the risk of exposure to BPA.
Informed by this research from the environmental sciences, and by confirmatory research in laboratory animals that are exposed to levels of Bisphenol A that are relevant to human exposures, the scientific community is becoming increasingly concerned about BPA’s adverse effects upon humans, particularly women of reproductive age, pregnant women, developing embryos, and young children.
Two points are chief among ARHP’s concerns about the FDA’s current assessment:
- Again, echoing last year’s BPA subcommittee document, ARHP believes that safety evaluations of chemicals should take into account the entire existing body of research. To date, over 100 publicly and privately funded studies have been completed or performed on the health effects of BPA exposure. To make its determination, the FDA used two of these existing studies both of which followed Good Laboratory Practices, or GLP – a set of standards commonly used by industry-based researchers. Many university-based and independent researchers do not use GLP standards because of the high costs associated, but are still using research methodology and design considered to be among the best in the world. The FDA should use the vast body of research available from non-GLP studies.
- Currently, there is a concern expressed among valued scientists that all BPA scientific studies are not created equal. Of the industry funded studies, including the two used by the FDA, none have found BPA to have health effects. However, over 100 studies have been conducted by independent NIH funded scientists and all have found health effects. This level of disparity among studies, particularly when the sharp contrast exists along funding lines, is alarming.
The FDA should reconsider its current assessment and bring to bear the weight of all existing research on BPA safety to reach its determination. In doing so, the FDA will ensure that the public benefits from all we currently know about low-dose chronic exposure to BPA.
ARHP supports the use of evidence-based science to inform clinical decision making. Unfortunately, we do not always have the data we want to guide us in making recommendations to patients. But absence of definitive evidence does not necessarily mean absence of harm. Ethical concerns prevent us from ever being able to conduct randomized double-blinded placebo controlled studies on pregnant women looking at various effects of various levels of exposure to BPA, or other endocrine disruptors like phthalates, Polybrominated Flame Retardants, Dioxin, Pesticides and perfluorinated compounds. Scientific uncertainty will therefore continue to exist.
In sum, ARHP’s two recommendations to the Science Board are to:
- Use all existing research to inform the FDA’s consideration of BPA’s safety; and
- In the absence of scientific certainty, err on the side of caution when taking any action that will affect public health, particularly with regards to BPA exposure to pregnant women and infants.
ARHP appreciates the important work the subcommittee on BPA has done in this area, and we look forward to the Science Board’s decision. Thank you for the time to comment on this important issue that potentially affects the health and lives of countless Americans.
About Audrey Kelly, PharmD