An agency, quietly, would spur vaccines

WASHINGTON -- By creating a federal agency shielded from public scrutiny, some legislators say they might speed the development and the testing of new drugs and vaccines needed to respond to a bioterrorist attack or super-flu pandemic.

The proposed Biomedical Advanced Research and Development Agency, or BARDA, would be exempt from open records and meetings laws that apply to most government departments, according to legislation that was approved Oct. 18 by the Senate Health Committee.

Those exemptions would streamline the development process, safeguard national security, and protect the proprietary interests of drug companies, the bill's Republican backers say. The bill also proposes giving manufacturers immunity from liability in exchange for participation in the public-private effort.

''We must ensure the federal government acts as a partner with the private sector, providing the incentives and protections necessary to bring more and better drugs and vaccines to market faster," Senator Richard Burr, a Republican of North Carolina, said when the Committee on Health, Education, Labor, and Pensions approved the bill.

The agency would provide the funding for development of treatments and vaccines to protect the United States from natural pandemics, as well as chemical, biological, and radiological agents.

But the secrecy and immunity provisions of the legislation have alarmed patient rights and open-government advocates. The agency would be exempt from the Freedom of Information Act and theFederal Advisory Committee Act. Both are considered key for monitoring government accountability.

''There is no other agency that I am aware of where the agency is totally exempt either from FOIA or FACA," said Pete Weitzel, coordinator of the Coalition of Journalists for Open Government. The coalition is an alliance of journalism groups, including the American Society of Newspaper Editors and Associated Press Managing Editors, that wrote to lawmakers seeking amendments to the bill. ''That is a cause for major concern and should raise major policy concerns," Weitzel said.

A Burr spokesman, Doug Heye, said the provisions would keep competitors from gaining proprietary information through FOIA. However, confidential information is exempt from FOIA. ''There's no secrecy involved in BARDA," Heye said. ''This is an agency that will be putting out information daily."

Some Democrats question whether the public would accept drugs or vaccines developed with the agency, citing the abortive 2003 effort to vaccinate 500,000 front-line healthcare workers against smallpox. Only about 40,000 workers ultimately received the vaccine amid concerns about its safety.

''Republican leaders in Congress are now proposing a plan that would make exactly the same mistake," said Senator Christopher J. Dodd, Democrat of Connecticut.

''Their plan," Dodd said, ''will protect companies that make ineffective or harmful medicines, and because it does not include compensation for those injured by a vaccine or drug, it will discourage first responders and patients from taking medicines to counter a biological attack or disease outbreak."

The bill does provide for limited compensation. However, another provision would grant drug companies immunity unless ''willful misconduct" can be shown.

The Pharmaceutical Research and Manufacturers of America said it was reviewing the bill. Another industry group, the Biotechnology Industry Organization, declined comment.

The National Vaccine Information Center, an advocacy group, called the legislation ''a drug company stockholder's dream and a consumer's worst nightmare."

The law was proposed amid concern about pandemics and the government's ability to meet them. For example, the United States needs three to five years to develop the capacity to produce 300 million doses of flu vaccine, Health and Human Services Secretary Michael Leavitt said last month on NBC's ''Meet the Press."

The agency would improve on Project BioShield, a barely two-year-old program also meant to encourage production of vaccines and drugs, Heye said.

''While some progress has been made, we still haven't seen the participation from companies, universities and research institutions in developing vaccines we might need to protect us from the next threat, whatever that might be," Heye said.

''One of the reasons," Heye added, ''is [they] don't want to put their very existence on the line."

Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, said the agency as proposed would represent a setback to decades of progress in opening up to the public the process of testing the safety and efficacy of a number of drugs.

''These provisions are extremely dangerous," Wolfe said.

''The fact that they are being proposed, really exploiting people's fears about pandemics and epidemics," Wolfe also said in an interview, ''is outrageous and goes backward on the progress on the use of the Freedom of Information Act and Federal Advisory Committee Act."

The motivation, Wolfe said, was probably ''to increase public scrutiny and increase the correctness of decisions that are made."