By creating a federal agency shielded from public scrutiny, some lawmakers
think they can speed the development and 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 long-standing open records and meetings laws that
apply to most government departments, according to legislation 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, say Republican
backers of the bill. The legislation also proposes giving manufacturers immunity
from liability in exchange for their 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," Sen. Richard Burr, R-N.C.,
said when the Committee on Health, Education, Labor and Pensions approved the
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 it is the secrecy and immunity provisions of the legislation that
have alarmed patient rights and open government advocates. The agency would
be exempt from the Freedom of Information and Federal Advisory Committee acts,
both considered crucial 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.
Burr spokesman Doug Heye said the provisions would keep competitors from gaining
proprietary information through FOIA. However, confidential business information
already is exempt from FOIA.
"There's no secrecy involved in BARDA," Heye said. "That is
absolutely false. This is an agency that will be putting out information daily."
Some Democrats question whether the public would accept drugs or vaccines developed
in conjunction with the agency, citing the abortive 2003 effort to vaccinate
500,000 front-line health care workers against smallpox. Only about 40,000 workers
ultimately received the vaccine amid concerns about the vaccine's safety, which
health authorities initially downplayed.
"Republican leaders in Congress are now proposing a plan that would make
exactly the same mistake," Sen. Chris Dodd, D-Conn., said in a statement.
"Their plan 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
The Pharmaceutical Research and Manufacturers of America said it was reviewing
the bill. Another industry group, the Biotechnology Industry Organization, declined
The National Vaccine Information Center, an advocacy group, called the legislation
"a drug company stockholder's dream and a consumer's worst nightmare."
The proposed law comes amid growing concern about pandemics and the government's
ability to meet such threats. For instance, the United State needs another three
to five years to develop the manufacturing capacity to produce 300 million doses
of flu vaccine, Health and Human Services Secretary Mike Leavitt said Sunday
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 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 drugs.
"These provisions are extremely dangerous," Wolfe said. "The
fact that they are being proposed, really exploiting people's fears about pandemics
and epidemics, is outrageous and goes backward on the progress on the use of
the Freedom of Information Act and Federal Advisory Committee Act to increase
public scrutiny and increase the correctness of decisions that are made."
Republican and Democratic lawmakers alike agree the drug industry needs some
protections to encourage it to produce emergency stocks of vaccines and drugs,
but Democrats have balked at providing blanket immunity without first establishing
a compensation fund for patients.
Republicans are pushing for liability protections for vaccine manufacturers
on other fronts as well. Senate Majority Leader Bill Frist, R-Tenn., is seeking
to add such protections to a defense appropriations bill.
Frist spokeswoman Amy Call said drug company concerns about liability are real.
"There's really no financial incentive for them to get into the market,
sell to the government at a reduced rate and then open themselves up to losses
that could potentially bankrupt them," Call said.
The push for liability exemptions may force the Burr bill to the sidelines
until the next session of Congress, Republican and Democratic aides said. But
Call said Frist intends to pursue the legislation.