[afro-nets] Federal Health Research Agency Exempt from Public Scrutiny

[Claudio Schuftan <claudio@hcmc.netnam.vn>]

Proposed New Federal Health Research Agency Exempt from Public
Scrutiny
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From: Nancy Krieger <nkrieger@hsph.harvard.edu>

fyi ... an item of concern, promising less transparency & ac-
countability vis a vis the production of vaccines and testing of
new drugs, and instead more secrecy and more protection of phar-
maceutical 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 Com-
mittee.

Those exemptions would streamline the development process, safe-
guard 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 Pen-
sions approved the bill.

The agency would provide the funding for development of treat-
ments 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 the Fed-
eral Advisory Committee Act. Both are considered key for moni-
toring 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."