Secretive Biodefense Legislation Moves Forward

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http://www.ombwatch.org/article/articleview/3598/1/1?TopicID=1

Secretive Biodefense Legislation Moves Forward

The House and Senate are nearing a vote on legislation to authorize a new

federal agency, the Biomedical Advanced Research and Development Agency

(BARDA), within the Department of Health and Human Services (HHS). The

agency would oversee " advanced research and development " of countermeasures

to bioterrorism threats, epidemics, and pandemics, and would have broad

authority to exempt information from public disclosure under the Freedom of

Information Act (FOIA).

Sponsored by Sens. Burr (R-NC) and Kennedy (D-MA), the

Pandemic and All-Hazards Preparedness Act (S. 3678) would create BARDA to

facilitate partnerships between industry and academia to meet public health

and national security needs. The legislation would also empower BARDA to

contract with academic institutions and pharmaceutical companies.

To carry out this mission, the bill's supporters argue, information

collected and used by BARDA needs protection from public disclosure.

According to Burr's staff, secrecy provisions help the government avoid

disclosing what the U.S. cannot protect itself against and how existing

bioterrorism and epidemic countermeasures could be defeated. The bill thus

specifies particular types of information that would be exempted from FOIA.

This approach is in almost direct contrast to the conclusions of the

National Research Council (NRC), which reviewed biochemical research and

bioterrorism safeguards in a recent report, entitled Globalization,

Biosecurity, and the Future of the Life Sciences. The NRC concluded that an

open and free exchange of scientific research and ideas is an essential

component of effective program to protect the country from a biochemical

attack or accident.

The legislation requires the Secretary of HHS to withhold from disclosure

under FOIA " specific technical data or scientific information that is

created or obtained during the countermeasure and product advanced research

and development funded by the Secretary that reveal vulnerabilities of

existing medical or public health defenses. " The Secretary would have to

review decisions to withhold every 5 years.

Another provision of S. 3678 exempts all anti-trust related information from

FOIA and declares decisions to restrict access to such information not

judicially reviewable. Moreover, the FOIA exemption does not appear to be

limited to information generated by BARDA but may include any and all

information at HHS.

In order to provide access to important health and safety information and to

ensure adequate oversight of government collaborations with the

pharmaceutical industry, S. 3678 needs revision:

a.. The requirement that the Secretary of HHS withhold certain sensitive

information should be revised to permit the Secretary to release certain

publicly valuable information.

b.. The FOIA exemption provision should include a provision that excludes

information which is already publicly accessible.

c.. The FOIA exemption should be limited to BARDA and BARDA-related

projects and should not permit the interpretation that it covers the entire

HHS.

d.. The review period for restricted information should be reduced from

every 5 years to every 2 years.

e.. Requests for protected information should trigger such reviews of the

restriction.

f.. The anti-trust FOIA exemption should be removed entirely.

Such modifications will ensure that sensitive information is protected while

providing access to information critical to harnessing the enormous resource

represented by the scientific, research, and public health communities in

the fight against disease and bioterrorism.

Introduced by Reps. Eshoo (D-CA) and Mike (R-MI), the Biodefense

and Pandemic Vaccine and Drug Development Act of 2006 (H.R. 5533) is the

companion bill to S. 3678 in the House. It contains identical language

exempting specific technical data or scientific information from release

under FOIA and establishing five-year mandatory reviews. It does not contain

the anti-trust FOIA exclusion, however. Both versions have passed out of

committee and may be considered on their respective floors this week.

Randi Airola

517-819-5926

When Good People do Nothing....

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