Senate Bill Calls For Secretive New Bioterrorism Research Center

WASHINGTON — A bill moving rapidly through the Senate would create a secretive national research center to respond to bioterror threats and natural disease outbreaks.

Some scientists cautioned Friday that the new agency could draw funds away from the Centers for Disease Control and Prevention and the National Institutes of Health, and disrupt their work.

The bill, said to be a priority of Senate Majority Leader Bill Frist, R-Tenn., would shift the main responsibility for developing bioterrorism countermeasures out of the Department of Homeland Security and into a new Biological Advanced Research and Development Agency (BARDA) in the Department of Health and Human Services (HHS).

The agency would be given a first-year budget of $1 billion, and some unusually strong powers.

It would have authority to shield drug manufacturers from liability lawsuits in the event a drug used to counteract a bioterrorism event or disease outbreak caused death or injury.

It also would be granted a blanket exemption from the federal Freedom of Information Act.

The bill creating BARDA was introduced by freshman Sen. Richard Burr, R-N.C., on Oct. 17 and approved the next day by the Health, Education, Labor and Pensions Committee.

Frist is one of five Republican co-sponsors, but some say the bill is actually his project.

In a June speech at Harvard University, Frist warned that the world may soon face "a front of unchecked and virulent epidemics, the potential of which should rise above your every other concern."

"I propose an unprecedented effort, the creation of a Manhattan Project for the 21st century, not with the goal of creating a new destructive agent, but to defend against infectious diseases and biological weapons."

Burr's press secretary confirmed Friday that BARDA would be the agency to carry out that project.

The press secretary, Doug Heye, said Burr's staff was negotiating with aides to Sen. Edward Kennedy, D-Mass., in an effort to get a bipartisan bill to the Senate floor as soon as possible.

Scientific organizations, some of which have been critical of delays by the Department of Homeland Security in identifying and counteracting bioterrorism threats, warned that the bill could disrupt existing disease agencies like CDC and the National Institute of Allergy and Infectious Diseases (NIAID).

NIAID recently created a network of 10 regional centers for research on bioterrorism, including one at Duke University in Burr's home state of North Carolina.

The Federation of American Societies for Experimental Biology said in a letter to Burr that it was "troubled over the impact this new agency might have on existing programs at the National Institutes of Health and the Centers for Disease Control and Prevention, particularly in an era of limited funding for discretionary spending."

"Our concern is BARDA might duplicate, constrain or even eliminate these programs," said Dr. Bruce Bistrian, a Harvard Medical School researcher who is president of the federation.

Other scientific organizations expressed similar concerns.

"Creation of a new and additional agency ... does not appear to be the best solution," Stanley Maloy, president of the American Society of Microbiology, said Friday in a letter to Burr.

Spokespersons for NIAID and CDC said the agencies do not comment on pending legislation.

Maureen McCarthy, director of research and development at the Department of Homeland Security, was asked at a recent Center for Strategic and International Studies conference to comment on the BARDA bill.

"We believe firmly that the organization of the biodefense world right now as it's established and the roles and responsibilities of the agencies is working and we're supportive of the current structure that exists," she said in a recorded response.

Groups representing scientists, news organizations and public accountability advocates have complained that the agency would be given unprecedented exemption from public scrutiny.

"This bill breaks new ground in the area of government secrecy," said Steven Aftergood, director of a Federation of American Scientists project on official secrecy.

Aftergood said other federal agencies can legally deny access to government documents if they decide the material deserves an exemption under the federal Freedom of Information Act (FOIA).

But BARDA would have blanket exemption for any FOIA requests, he said.

"It is an insult to the public," Aftergood said.

"These provisions turn the concepts of 'open government' and 'democracy' on their heads," said the Coalition of Journalists for Open Government in a letter to senators. "To our knowledge, an entire agency has never received a blanket exemption from compliance with the Freedom of Information Act.

"Even those agencies which deal with sensitive national security information on a regular basis — including the Central Intelligence Agency, the Department of Homeland Security, and the Department of Defense — must comply with FOIA," the letter states.

Rutgers University biologist Richard Ebright called the bill "essential and overdue" because it would bring central coordination to U.S. biodefense efforts, which he said have been marked by "duplication, waste and minimal progress."

"Unfortunately," he said, "the Burr bill also calls for unprecedented, nearly absolute, exemptions of the coordinating agency from public accountability and of contractors from liability."

"These exemptions need to be sharply curtailed, or even stripped from the bill," he said.

Heye, Burr's press secretary, said that "this agency will be about providing information, not withholding it." He said the measure was meant to remove barriers to the development and production of drugs to defend Americans against infectious disease threats and bioterrorism events."

The bill states:

"Information that relates to the activities, working groups, and advisory boards of the BARDA shall not be subject to disclosure under section 552 of title 5, United States Code, unless the Secretary or Director determines that such disclosure would pose no threat to national security. Such a determination shall not be subject to judicial review."

Section 552 is the Freedom of Information Act.

Although the measure does not require BARDA's director to respond to FOIA requests, it contains no requirement that employees of the agency maintain secrecy about matters that are deemed to involve national security.