Commentary: Biodefense and the Freedom of Information ActBy Beth Wellington, Published on November 22, 2006
On June 21, 2006, The Center for Arms Control and Non-Proliferation released its analysis, US Federal Spending on Biodefense from 2001-2007. It excluded funding for funding for pandemic and avian influenza, although "since FY2004, DHHS has received approximately $3.5 billion in pandemic influenza funding, an additional $2.6 billion is requested for FY2007. USDA is requesting $82 million for avian influenza in FY2007."
Stebbins commented in his June 30, 2006 entry for the FAS Strategic Security Blog,
"The numbers are staggering: Since 2001 the U.S. government has spent or allocated over $36 billion among 11 federal departments and agencies on biodefense. The Bush Administration has proposed $8 billion in biodefense spending for FY '07, approximately $120 million (or 1.5%) over the '06 appropriation. Of particular interest was that only 2% of all federal biodefense funding has been devoted to efforts to prevent the development, acquisition, and use of biological weapons by other nations and terrorists."
I've already written about how the House rushed through legislation before the August recess and it did so again in the days before recessing September 30, to allow members to campaign for reelection. The House Rules Committee reported a series of special rules, including House Resolution 1045 submitted on September 27 and agreed to by voice vote on September 28,
"...that it shall be in order at any time through the legislative day of September 29, 2006, for the Speaker to entertain motions that the House suspend the rules. The Speaker or his designee shall consult with the Minority Leader or her designee on the designation of any matter for consideration pursuant to this resolution."
But on September 26, without even a special rule, the Biodefense and Pandemic Vaccine and Drug Development Act of 2006,H.R. 5355 (See the Congressional Record pages H7445-7447), was reported at 6:40 p.m. and passed on a voice vote at 8:01 p.m., after a motion on the floor to suspend the rules.
September 28, the Lansing (MI) State Journal's correspondent Katherine Hutt Scott called H.R. 5533 a "noncontroversial bill" in her article, "Rogers' biodefense bill clears House: Area vaccine manufacturer BioPort Corp. could benefit."
BioPort, is the Lansing-based subsidiary of Emergent BioSolutions of Gaithersburg, MD, and holds a $120 million contract with the federal government to make 5 million doses of anthrax vaccine by September 2007. The vaccine would be part of a stockpile of medicines, called Project BioShield, designed to protect Americans during a terrorist attack. BioPort is also working on a new anthrax vaccine that could be delivered in pill or patch form and on developing typhoid and hepatitis B vaccines.
The biotech industry likes the bill because it would allow advance payments to vaccine and drug manufacturers to help them finish developing new products.But while the measure passed the house under a special rule, it is hardly non controversial. Henry Waxman (D-CA) spoke to the issues in the limited House debate September 26, urging that they be addressed in the conference bill. First, he raised the issue of the FOIA exemptions:
"This bill contains exemptions from important federal open government laws designed to ensure accountability and transparency, like the Freedom of Information Act (FOIA) and federal procurement law. These open government laws are within the jurisdiction of the Committee on Government Reform, on which I am the ranking member, but unfortunately, the Government Reform Committee did not have an opportunity to consider the bill...
H.R. 5533 establishes a new FOIA exemption....While this exemption appears narrow in scope, the Administration has a long record of interpreting narrow language broadly to withhold public information. Unless there is a compelling reason why the existing FOIA exemptions are inadequate--which there does not appear to be in this case--it is unwise to add new exemptions to FOIA. Moreover, the language of the new exemption is not clear. The language applies to any "advanced research and development that is funded by the Secretary,'' which may inappropriately extend the exemption far beyond BARDA to other research funded by the Department of Health and Human Services."
He also questioned the waiver from federal procurement law:
"...other transaction authority ''...[waives] everything from competition requirements, to auditing and pricing safeguards, to the Buy America and Drug-free workplace laws. The authority was originally developed to help DOD in attracting smaller contractors to federal research and development contracts, though in practice it has not often been used to accomplish that objective....If such a rationale exists, we should explore ways to limit its application at BARDA to those instances where it is truly needed, as opposed to the blanket grant of authority currently in H.R. 5533."
Waxman also pointed out that the advisory committees set up under BARDA would be exempted from section 14 of the Federal Advisory Committee Act which ensures
"their ongoing necessity. Again, there is no clear explanation for why this waiver of current law is necessary, or what interests would be protected by exempting the committees from renewal requirements."
The latest related Senate legislation, S. 3678, introduced by Senator Burr (R-NC) on July 18, 2006, for himself and Senators Edward M. Kennedy (D-MA), Barbara A. Mikulski (D-MD), Tom Harkin (D-IA), Mike Enzi, Gregg, and Bill Frist (R-TN) was marked up the HELP Committee on July 19, with the report (S. Rept. 109-319) filed on August 4, with no further action taken.. Joanne Carney, writing in the AAAS Science and Technology Newsletter for September 2006 explained that the bill "was brought to the floor on the last day before the chamber recessed but failed to reach a unanimous consent agreement to pass because a number of germane and non germane amendments stalled its movement."
The Office on Legislative Policy and Analysis of the National Institute of Health published a legislative update which lays out the various bio-terrorism measures.
Waxman was raising the long-expressed concerns by citizen advocacy groups to last year's similar version in the the Senate, Burr (R-NC) S. 1873. H.B. 5533 proposes total exemption from the Freedom of Information Act for a newly created agency, the Biomedical Advanced Research and Development Authority (BARDA) to develop drug technologies and vaccines to respond to natural outbreaks and bioterrorism.
Writing about S. 1873 on November 5, 2005, Jeff Nesmith of the Atlanta Journal Constitution noted that while the sponsor was Burr,
"Frist is one of five Republican co-sponsors, and the bill is believed to be his project.
In a June speech at Harvard University, Frist warned that the world may soon face "a front of unchecked and virulent epidemics, the potential of which should rise above your every other concern."
"I propose an unprecedented effort, the creation of a Manhattan Project for the 21st century, not with the goal of creating a new destructive agent, but to defend against infectious diseases and biological weapons."
Scientific organizations, some of which have been critical of delays by the Department of Homeland Security in identifying and counteracting bioterrorism threats, warned that the bill could disrupt existing disease agencies like the CDC and the National Institute of Allergy and Infectious Diseases."
Similar to this predecessor in the Senate, H.R. 5533 mandates that the Secretary of Health and Human Services withhold technical and scientific information that would "reveal vulnerabilities of existing medical or public health defenses" against biological threats. It establishes a five-year blackout on reviewing withholding decisions.
The bill follows up on issues raised at a Subcommittee on Health hearing held on April 6, 2006, `Project Bioshield Reauthorization Issues, which heard testimony from: The Honorable Alex M. Azar, Deputy Secretary, U.S. Department of Health and Human Services; Mr. Jean D. Reed, Special Assistant, Chemical and Biological Defense and Chemical Demilitarization Programs, Office of the Assistant to the Secretary of Defense for Nuclear and Chemical and Biological Defense, U.S. Department of Defense; Dr. Tara O'Toole, CEO and Director, Center for Biosecurity, University of Pittsburgh Medical Center; Mr. Peter F. Young, President and CEO, AlphaVax, Inc, on behalf of the Biotechnology Industry Organization; Mr. Bruce Cohen, President and CEO, Cellerant Therapeutics, Inc.; Dr. David P. Wright, President and CEO, PharmAthene, on behalf of the Alliance for Biosecurity; and Dr. Martin Blaser, President, Infectious Diseases Society of America.
H.R. 5533, introduced June 6, 2006 by Mike Rogers (R-MI), arrived that date at the House Committee on Energy and Commerce, which referred it on June 23 to its Subcommittee on Health. On September 20, the Committee held a mark-up session and ordered the bill reported (House Report 109-686). Interestingly, Clause 3(b) of rule XIII of the Rules of the House of Representatives requires the Committee to list the record votes on the motion to report legislation and amendments thereto. There were no record votes taken in connection with ordering H.R. 5533 reported. The motion by Mr. Barton to order H.R. 5533 reported as amended, was agreed to by a voice vote, according to House Report 686. The report also explains the background of the bill:
"Project BioShield was signed into law on July 21, 2004, to encourage the development of countermeasures to address chemical, biological, radiological, and nuclear threats. The legislation provided procedures for bioterrorism-related procurement, hiring, and awarding of research grants, in an effort to make it easier for the Federal government to quickly commit substantial funds to countermeasure projects. Congress has identified a number of improvements to fully realize Project BioShield's potential and to provide further incentives toward such development. H.R. 5533 provides a single point of authority within the Department of Health and Human Services for the advanced research and development of medical countermeasures to make important procurement decisions. The legislation provides needed authorization to fund advanced research and development activities that were not covered by Project Bioshield. Additionally, the legislation will provide for further purchasing and contractual flexibility."
In "Biodefence special: Fortress America? " in the October 6, 2006 New Scientist, Debora MacKenzie writes on what spurred the passage of Bio-guard, "It was the nightmare many had been expecting. Five years ago, hard on the heels of 9/11, someone sent anthrax spores through the US mail to journalists and politicians. Five people died, and at least 17 more got sick. The culprit was never caught."
This relatively unsophisticated attack confirmed fears, already growing in the US, that with a bit more effort a determined bioterrorist could spread disease and mayhem across the nation.
Bio-guard has spent $44 billion - three-quarters of it aimed at protecting civilians - on new organizations, training, and buying existing remedies such as the classic smallpox vaccine. Yet, according to MacKenzie, last month the Center for Biosecurity at the University of Pittsburgh announced that the U.S. remains unable to defend itself against any anthrax attack involving more than a few envelopes. She also reports on how most research covered under the act may be misguided or soon become obsolete, because it promotes vaccines for specific diseases rather than a broad spectrum approach.
Additionally, "Fort Detrick Poses a Threat to Frederick, Md.--and to Humanity" by Frederick, Maryland attorney Barry Kissen and Baltimore peace and environmental activist Richard Ochs [September 28, 2006], points out that:
"The NIH budget for medical research priorities has been slashed to help pay for bioweapons research--yet any bioterror threat pales in significance compared with diseases which already kill tens of thousands.--"
On September 26, 2006 Open the Government, some of its coalition members and other groups sent a letter to key members of Congress, urging the language of HR 5533 be modified:
· to provide more specific guidance on the information covered
· to give the secretary discretion to release information that he believes could be shared publicly, and
· to shorten the review period to two years.
"While well-intentioned, this language is vague and all but certain to result in inappropriate withholding of information that needs to be shared for reasons related to both public accountability and national security. All of the research and development activities that BARDA would pursue are directed at reducing our nation's vulnerabilities. What then are the limits on information that must be withheld? The legislation provides no guidance on this question, and allows no discretion. In the fast-moving area of biomedical research, a five-year blackout is unwise and likely to be counter-productive in many instances.
The legislation might also prevent the results of important fundamental research from being shared with other scientists who need to know. For instance, basic research on new broad spectrum anti-microbials is essential in the face of naturally-occurring but rapidly increasing antibiotic resistant bacterial infections. Yet, such research could reveal vulnerabilities and thus could fall within the broad language of the law. Withholding such information runs counter to long-standing U.S. policy that fundamental research be open, that the benefits of such openness outweigh the risks.
Indeed, the U.S. leads the world in biomedical research. Our experience has shown that robust and effective vaccine and drug development can only take place in a climate of timely and free exchange of materials and information. In contrast, secrecy in bioweapons related research will not only harm our biodefense vaccine and drug development efforts, but will set a poor example that other nations may follow to our chagrin.
Moreover, given the widespread criticism that the Department and Project BioShield have already received for lack of results and accountability, we believe that Congress should strive to make the BARDA as transparent as possible while ensuring necessary national security."
Open the Government coalition members signing the letter were:
- American Library Association
- National Freedom of Information Coalition
- American Association of Law Libraries
- OMB Watch
- Californians Aware
- Center for Democracy and Technology
- Project On Government Oversight
- Reporters Committee for Freedom of the Press
- Government Accountability Project
Other groups signing the letter were:
- Alternatives for Community & Environment, Inc.
- Center for National Security Studies
- Public Citizen
- Coalition of Journalists for Open Government
- Council for a Livable World
- Physicians for Social Responsibility (San Francisco Chapter)
- Council for Responsible Genetics
- The Edmonds Institute
- Scientists Working Group on Biological and Chemical Weapons
- The Sunshine Project
In her March 17, 2006 Winston-Salem (NC) Journal story, Burr to revive biomedical bill: Senator wants oversight on research; critics want less secrecy, Mary M. Shaffrey (email) explained why drug companies support the FOIA act exemptions for BARDA. Peter Young, the president of AlphaVax, a vaccine company based in North Carolina's Research Triangle Park, does not want to have greater exposure of proprietary information than he faces under the regular development process. Government
has to create a middle ground where there is still enough of an incentive for companies to participate.
This appears to be a red herring. Confidential business information already is exempt from FOIA. Shaffrey credits critics of the FOIA exemption for stopping Burr's (R-NC) earlier efforts to establish BARDA
Steven Aftergood, the director of the FAS's Project on Government Secrecy wrote about BARDA, as introduced in S. 1873, in his October 26, 2005 edition of Secrecy News, and noted that Nick Schwellenbach of the Project on Government Oversight (POGO) had observed,
"Even intelligence agencies and the Defense Department do not have blanket exemptions from FOIA..."
POGO's blog entry for October 20, 2005, noted
"Exempting BARDA would mean congressional and public oversight of the agency and its important activities would be severely curtailed."
On October 24, 2005, Dr. Alan M. Pearson (email), Biological and Chemical Weapons Control Program Director of the Center for Arms Control and Non-Proliferation's and Lynn C Klotz (email), the senior science fellow there, sent an open letter to the Senate. They said the earlier incarnation of Burr's bill, S. 1873, the Biodefense and Pandemic Vaccine and Drug Development Act failed to ensure biosecurity because:
"it fails to include provisions for enhancing international cooperation and international public health. Second, it mandates secrecy in areas where transparency is both appropriate and necessary for the public's health and security...
Secrecy is inappropriate when developing countermeasures for natural infectious disease, the need that S.1873 seeks to address. Indeed, robust and effective countermeasure development can take place only in a climate of timely and free exchange of materials and information. Moreover, public accountability is essential for ensuring that the activities envisioned in S. 1873 meet our nation's biodefense and public health needs.
Accountability is all the more important because S. 1873 exempts all contracts, grants, cooperative agreements and other transactions under the Project BioShield Act of 2004 from the cost principle and accounting standards set forth in the Federal Acquisition Regulations (see p. 25, line 3 - 15 of S. 1873 as introduced). Recent concerns about FDA regulatory oversight mechanisms clearly demonstrate the importance of transparency and accountability for public health.
Our biosecurity will be better served if public disclosure of all information related to the activities, working groups, and advisory boards of the BARDA is mandated, except in special circumstances where the Secretary or Director determines that disclosure would be an obvious threat to our national security.
Finally, suspicions on the part of nations about the intent of each other's biodefense activities can lead to an arms race in biological weapons. A high-level of transparency in biodefense activities can reduce suspicions, thereby reducing the risk of an international arms race. International cooperation in the form of consultation, oversight, and co-development of countermeasures implicitly contribute to transparency."
Pearson compiled an index of coverage on the secrecy issue, as of December 12, 2005, at his organizations site. Besides serving at the Center, he is a Global Security Science and Technology Fellow for the American Association for the Advancement of Science and the Nuclear Threat Initiative at the Department of Homeland Security. Klotz, a biotechnology consultant, formerly served on the Harvard faculty and as a biotechnology executive.
Jeff Nesmith's article for the Atlanta Constitution is no longer available free of charge; however it was distributed by Cox on November 12, as "Senate Bill Calls For Secretive New Bioterrorism Research Center." In it he quotes extensively from critics among the scientific community. For instance, the Federation of American Societies for Experimental Biology said in a letter to Burr that it was
"troubled over the impact this new agency might have on existing programs at the National Institutes of Health and the Centers for Disease Control and Prevention, particularly in an era of limited funding for discretionary spending."
Dr. Bruce Bistrian, a Harvard Medical School researcher who is president of the federation said,
"Our concern is BARDA might duplicate, constrain or even eliminate these programs."
Stanley Maloy, president of the American Society of Microbiology, said in a letter to Burr.
"Creation of a new and additional agency ... does not appear to be the best solution."
Nesmith also notes that Maureen McCarthy, director of research and development at the Department of Homeland Security, was asked at a Center for Strategic and International Studies conference to comment on the BARDA bill.
"We believe firmly that the organization of the biodefense world right now as it's established and the roles and responsibilities of the agencies is working and we're supportive of the current structure that exists. response."
While Rutgers University biologist Richard Ebright called the bill "essential and overdue" because it would bring central coordination to U.S. biodefense efforts, which he said have been marked by "duplication, waste and minimal progress." he added,
"Unfortunately, the Burr bill also calls for unprecedented, nearly absolute, exemptions of the coordinating agency from public accountability and of contractors from liability.
These exemptions need to be sharply curtailed, or even stripped from the bill."
Republicans like to tar Democrats, especially liberals, with the promotion of "tax and spend" big government, so it is ironic that Senator Ted Kennedy, (D-MA), one of the true liberals in Congress, introduced an alternative measure, The National Biodefense and Pandemic Preparedness Act of 2005 (S. 1880) which instead of setting up a new federal agency, BARDA, proposed organizing the existing biomedical infrastructure through a National BioVenture Trust, a federal government corporation to be set up to administer the BioShield Act and support the development of bioterrorism countermeasures using the existing Health and Human Services, NIH and corporate infrastructure.
"There is little question that this approach would have a lower overhead then BARDA, but it is unclear if such a trust would be as susceptible to the bureaucratic comorbidity that has made Bioshield so ineffective. This bill also extends the liability protection for health professionals administering smallpox countermeasures to include new countermeasures. It simultaneously provides for an injury compensation program, which is essential in the event that vaccines or medications have to be disbursed before they have passed through the rigors of the full clinical trial process. It also requires that countermeasures be post-market tested after an emergency distribution. The bill also calls for the establishment of a National Advisory Committee on Vulnerable Populations and Terrorism, a Select Agent Advisory Committee, but like the plethora of other Committees in Washington, they will have little or no authority...
Both of these bills call for an expansion of government, which is needed to direct the new efforts and goals set out in these bills. But S.1880 does so without creating an entirely new agency. I haven't actually been able to get anyone to explain why we would need a completely new agency to do this though...I hope we will see objective independent evaluations...before we run headlong into these new ventures. "
To protect the safety and well-being of our families, homes, and communities; to hold our government accountable; and to defend the freedoms upon which our democracy depends; we, the undersigned individuals and organizations, believe the public has a right to information held by our government.
The American way of life demands that government operate in the open to be responsive to the public, to foster trust and confidence in government, and to encourage public participation in civic and government institutions. The public's right to know promotes equal and equitable access to government, encourages integrity in official conduct, and prevents undisclosed and undue influence from special interests.
I just received an update from the group that that the House passed H.R. 5533 on September 26 to "create the Biomedical Advanced Research and Development Authority (BARDA) to develop drug technologies and vaccines to respond to natural outbreaks and bioterrorism. Language in the bill mandates that the Secretary of Health and Human Services withhold technical and scientific information that would "reveal vulnerabilities of existing medical or public health defenses" against biological threats. It establishes a five-year blackout on reviewing withholding decisions."
By the way, here are links to other Open the Government Coalition members:
American Booksellers Foundation for Free Expression
American Society of Newspaper Editors
Association of American Publishers
Association For Community Networking
Association of Research Libraries
Center for American Progress
The Center for Public Integrity
Electronic Frontier Foundation
Electronic Privacy Information Center
Federation of American Scientists
First Amendment Foundation
Florida First Amendment Foundation
Friends Committee on National Legislation
Fund for Constitutional Government
Humanist Society of New Mexico
Human Rights First
Illinois Community Technology Coalition
Indiana Coalition for Open Government
Institute for Defense and Disarmament Studies
League of Women Voters
National Coalition Against Censorship
National Coalition for History
National Committee Against Repressive Legislation
National Security Archive
National Security Whistleblowers Coalition
New Jersey Work Environment Council
Northern California Association of Law Libraries
Peace Corps Online
PEN American Center
People For the American Way
Political Research Associates
Positive Financial Advisors, Inc
Public Employees for Environmental Responsibility
Society of American Archivists
Society of Professional Journalists
Southeastern American Association of Law Libraries
Special Libraries Association
U.S. Public Interest Research Group
Working Group on Community Right-to-Know
Ironically, in other news from Open the Government, Section 525 of the House version of the Department of Homeland Security Appropriations Act to limit the use of the Sensitive Security Information (SSI) control marking, particularly by the Transportation Security Administration.
September 27, 2006 the House Government Reform Subcommittee on Government Management, Finance and Accountability approved the OPEN Government Act, H.R. 867, which established measures to hold agencies more accountable for fulfilling public requests for documents under the Freedom of Information Act. It awaits approval by the full committee. The Senate Judiciary Committee approved its version, September 21.
When the lame-duck session returns after the recess, it will be interesting to see whether BARDA maintains its FOIA exemptions, or whether the open government groups can once again prevail.