PHA-Exchange> proposed new federal health research agency exempt from public scrutiny

[Claudio]

From: "Nancy Krieger" <nkrieger at hsph.harvard.edu>

fyi ... an item of concern, promising less transparency & accountability
vis a vis the production of vaccines and testing of new drugs, and instead
more secrecy and more protection of pharmaceutical companies from public
scrutiny & liability (hence market concerns again trumping actual
public health needs ...)

THE BOSTON GLOBE:
By Andrew Bridges, Associated Press  |  December 4, 2005

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.

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

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