May 15, 2003

Thank you, Mr. Chairman, for scheduling this markup of the Project Bioshield Act of 2003. This legislation reflects bipartisan negotiations that have significantly improved the language submitted to us by the Administration. That is a credit to this Committee and I commend all who participated in this endeavor.

Project Bioshield is unfortunately a necessary measure in view of the increased risk of harm to Americans in this era of heightened threats to our national security. There are no effective therapies for many of the "select agents" that have been identified as potential instrumentalities of terrorism. The basic purpose of Project Bioshield is to support research that will lead to the development and availability in the Strategic National Stockpile of "countermeasures" to combat public health emergencies that threaten our national security.

The bill has three basic features: enhanced countermeasure research; procurement of countermeasures; and emergency regulatory authority for approval and use of drugs, biologics, and devices that are qualified countermeasures. The Committee’s work clarified, modified, and otherwise improved on the Administration’s proposal in each of these areas.

Significantly, the bill before us contains an additional section that enhances accountability for actions taken pursuant to Project Bioshield. Congress will receive comprehensive information, not less than annually, on the major activities authorized by this act. In addition, the General Accounting Office and the National Academy of Sciences will provide reports on key economic and scientific elements of this program after it has been in effect for several years.

Finally, I commend the Chairman for deciding to proceed with an authorization for funding, rather than with the mandatory appropriation sought by the Administration. Bioshield should not automatically be given a higher priority over other national security or public health matters.