Gawd.....

Anti-disease agency would be exempt from rules



2005-11-12 / KNIGHT RIDDER / By Mark Tapscott

Members of Congress are moving rapidly to create a new federal agency designed to manage the government's anti-bio-terrorism research and encourage private companies to bring more drugs and vaccines to market quicker.
Sounds good. But there's a catch.

The proposed Biomedical Advanced Research and Development Agency intended to be part of the U.S. Department of Health and Human Services, would be exempt from the federal Freedom of Information Act. It also would be exempt from rules designed to ensure efficiency and protect against waste and fraud.

In other words, BARDA would escape public and judicial oversight, even though it would have billions of tax dollars to spend, with much of it likely going to favored drug industry firms.

Senator Richard Burr is the main sponsor behind BARDA. He says the agency is needed to "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."

Burr is chairman of the Senate's Bio-terrorism and Public Health Preparedness Subcommittee. At first glance, Burr's BARDA bill seems promising, but closer inspection reveals some major problems that haven't received public attention, beginning with the FOIA exemption.

The bill explains special treatment

Here's how the BARDA bill explains the FOIA exemption:

"Information that relates to the activities, working groups and advisory boards of the BARDA shall not be subject to disclosure under (the FOIA) unless the Secretary or Director determines that such disclosure would pose no threat to national security."

The bill also adds this provision to the FOIA exemption: "Such a determination shall not be subject to judicial review." Those 10 simple words mean BARDA will essentially be accountable to nobody and can operate without having to worry about troublesome interference from courts or private citizens like you and me.

Nobody doubts that government should do everything possible to protect citizens from terrorist attacks using biological agents and from natural-disease threats such as an Avian Flu pandemic.

But what would this new federal agency be enabled to do that the Department of Homeland Security or Department of Defense cannot already do? If there are things only a new agency can do, what does that tell us about the efficacy of the billions spent during the Cold War to prepare for potential Soviet attacks using biological weapons? What about the billions spent since 9-11 to prepare for new terrorist attacks that experts tell us are inevitable?

Then there is the question of why we should exempt an entire agency from the FOIA and judicial review? Not even the Defense Department or the CIA enjoys such blanket exemptions. The traditional approach has been to exempt specific categories of documents rather than whole agencies.

That's why the FOIA has long had an exemption to prevent disclosure of materials whose release would threaten national security. Why isn't that exemption sufficient for the new agency? If BARDA is approved as it's now proposed, it would be the first federal agency outside the intelligence community to be wholly exempted from the FOIA.

Also exempt from the FACA

BARDA also would be exempt from the Federal Advisory Committee Act and major portions of the Federal Acquisition Regulations. The former requires that advisory panels that help federal agencies make policy must meet in public in order to protect against conflicts of interest among participants. Sharp-eyed readers will recall that Hillary Clinton's massive health-care reform panels ran afoul of this Act.

The Federal Acquisition Regulations, meanwhile, are designed to insure that taxpayers get fair value for their money when federal agencies purchase everything from advice on personnel management to preventing pollution with zinc.

Just how big an agency would BARDA be? Well, it's biggest initial project will likely be taking over Project Bio-shield, the US$5.6 billion initiative announced two years ago to stimulate the creation of a new bio-defense industry through government contracts and incentives.

Some lawmakers contend that BARDA is needed now because Project Bio-Shield didn't create enough incentives for the private sector, since it focused only on vaccines for which the government would be the lone purchaser. Of course, without FOIA, how will we ever know if BARDA is making real progress fast enough on the terrorist and natural threats most likely to do the worst harm to largest number of Americans? Before it's too late?

Mark Tapscott is director of the Center for Media and Public Policy at The Heritage Foundation.