MARCH 27, 2003

Mr. Bilirakis, thank you for holding this hearing. We need to continue to focus our attention on the important and time-sensitive issue of preparing for the possibility of a biological, chemical, or radiological attack. I look forward to hearing from all of our witnesses today. I am especially pleased to welcome my good friend from the University of Michigan, Dr. James Baker.

We are here today to examine the Administration’s proposed "Project Bioshield Act of 2003". This bill has three main components: it seeks to accelerate research at the National Institutes for Health (NIH) for the purposes of developing new biomedical countermeasures; it provides a guaranteed market to manufacturers of drug and medical device countermeasures; and it authorizes new Food and Drug Administration (FDA) emergency use authorization for treatments and products still under development. The overall goal of this legislation has merit. Some of its specific provisions may be cause for concern, however, so I am anxious to learn more about them. For example, the appropriations section of the Administration’s bill provides unlimited, indefinite appropriations for research and development of biomedical countermeasures. A blank check is usually a bad idea. At the same time, other provisions of the bill relax basic procurement laws aimed at preventing waste, fraud, and abuse. This is usually a bad idea as well.

There are also other questions of interest to me in the Project Bioshield Act of 2003. How will the government price products under the five year contracts specified in the bill? Why does the bill allow for discounted prices for unlicensed and unapproved products? Shouldn’t there be more specific definitions for certain terms contained within this bill, such as "product," "significant market," and "pressing research needs"?

I thank our witnesses for their help as we begin forging the useful and well-intended Administration proposal into more workable legislation.