Biological Weapons Experts Call for Revisions to BioShield II Legislation October 25, 2005 For more information contact: Alan Pearson, apearson@armscontrolcenter.org

FOR IMMEDIATE RELEASE Press Contact: Alan Pearson Phone: 202-546-0795 x107 email: apearson@armscontrolcenter.org

Washington, DC (October 25, 2005)

Biological weapons experts at the Center for Arms Control and Non-Proliferation called yesterday for changes in the BioShield II legislation currently making its way through the U.S. Senate (S. 1873 - the “Biodefense and Pandemic Vaccine and Drug Development Act”) that would increase transparency and international cooperation in U.S. biodefense.

In a letter distributed to all U.S. Senators, Alan Pearson, Director of the Center’s Program on Biological and Chemical Weapons Control, and Lynn Klotz, a biotechnology consultant and former biotechnology executive who is Senior Science Fellow at the Center, noted that the legislation “laudably seeks to correct weaknesses in the Project BioShield Act of 2004.” However, they said, it “falls short. In particular, …[it] fails to address two key aspects of our biosecurity.”

According to Pearson and Klotz, “biosecurity at home relies on biosecurity throughout the world. Epidemics and pandemics of naturally occurring disease outside our borders can be a major threat to the U.S., as could a biological weapons attack.” They noted that the current legislation “fails to … include provisions for enhancing international cooperation and public health, such as strengthening and integrating international infectious disease surveillance.”

Pearson and Klotz also said that the legislation “mandates secrecy in areas where transparency is both appropriate and necessary for the public’s health and security.” In particular, they pointed to language which exempts the newly envisioned Biodefense Advanced Research and Development Agency from the Freedom of Information Act (FOIA). The said that “all information relating either directly or indirectly to this new agency could be withheld from public disclosure unless the Secretary of Health and Human Services or the Director of the Agency specifically determines, on a case by case basis, that such disclosure would not pose a threat to national security.” Pearson said that “this stands FOIA on its head.”

In their letter, Pearson and Klotz wrote that such “secrecy is inappropriate when developing [drugs and other] countermeasures for natural infectious disease. … Robust and effective countermeasure development can take place only in a climate of timely and free exchange of materials and information.” They continued “public accountability is essential for ensuring that the activities envisioned in [this legislation] … meet our nation’s biodefense and public health needs.” Yet, “if enacted as is, this legislation will dramatically reduce the level of public accountability for” such efforts. They noted that “recent concerns about FDA regulatory oversight … clearly demonstrate the importance of transparency and accountability for public health.”

Pearson and Klotz noted that lack of transparency can also fuel “suspicions on the part of nation’s about the intent of each other’s biodefense activities. … A high level of transparency in biodefense activities can reduce suspicions, thereby reducing the risk of an international [biological weapons] arms race.”

In their letter to the Senators, Pearson and Klotz concluded that “our biosecurity will be better served if public disclosure of all information related to … the BARDA is mandated, except in special circumstances where the Secretary [of Health and Human Services} or Director [of BARDA] determines that disclosure would be an obvious threat to our national security.” Tying transparency to international cooperation, they noted that “international cooperation in the form of consultation, oversight, and co-development of countermeasures implicitly contributes to transparency.” ¹⁾

See also-“Even intelligence agencies and the Defense Department do not have blanket exemptions from FOIA” - Nick Schwellenbach of the Project on Government Oversight. See a statement on the POGO blog here -

S. 1873 Biodefense and Pandemic Vaccine Drug Development Act of 2005

(Bio)Shielding Industry

This Tuesday, October 18, a Senate committee moved a bill forward that would create a new agency within the Department of Health and Human Services (HHS). This new agency would help spur private industry to develop and manufacture medical countermeasures for bioterrorism agents and natural outbreaks such as a possible avian flu pandemic. But the bill also makes oversight and accountability of much of America's biodefense efforts nearly impossible.

S. 1873, the Biodefense and Pandemic Vaccine and Drug Development Act of 2005, exempts industry from liability and a new agency within HHS, the Biomedical Advanced Research and Development Agency (BARDA) from the Freedom of Information Act (FOIA), the Federal Advisory Committee Act (FACA) and parts of the Federal Acquisition Regulations (FAR). Here's the October 17, 2005 text of the legislation (pdf).

Global Security Newswire lists other questionable aspects of the bill, such as forbidding government purchases of generic drugs thus tying the government's hands.

Several groups such as the National Vaccine Information Center and the Center for Justice and Democracy are opposed to the indemnification of industry. And we at POGO don’t see how exempting BARDA from FOIA, FACA and FAR cost/accounting standards can even be justified.

BARDA would be responsible for handling the $5.6 billion Project Bioshield initiative to create a new biodefense industry with government incentives and contracts. Exempting BARDA would mean congressional and public oversight of the agency and its important activities would be severely curtailed. A less effective agency and an American public more vulnerable than it should be are the likely results of this erosion of transparency. ²⁾