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Secretive Biodefense Legislation Moves Forward

OMB Watch

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. Richard Burr (R-NC) and Edward 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:

The requirement that the Secretary of HHS withhold certain sensitive information should be revised to permit the Secretary to release certain publicly valuable information.

The FOIA exemption provision should include a provision that excludes information which is already publicly accessible.

The FOIA exemption should be limited to BARDA and BARDA-related projects and should not permit the interpretation that it covers the entire HHS.

The review period for restricted information should be reduced from every 5 years to every 2 years.

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

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. Anna Eshoo (D-CA) and Mike Rogers (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.