BARDA

On June 18, 2008 the National Biodefense Science Board held their second meeting. The NBSB was created under the 2006 Pandemic and All-Hazards Preparedness Act and was established to provide expert advice and guidance to the Secretary of the U.S. Department of Health and Human Services (HHS) on scientific, technical, and other matters of special interest to HHS regarding activities to prevent, prepare for, and respond to adverse health effects of public health emergencies resulting from chemical, biological, nuclear, and radiological (CBRN) events, whether naturally occurring, accidental, or deliberate. During the inaugural meeting of the NBSB on Dec 17-18, 2007 members were sworn in and working groups were formed to consider the issues members felt were important.

The meeting began with a presentation from Robin Robinson, the newly named the Director of the Biomedical Advanced Research and Development Authority (BARDA), on “Old & New Perspectives at BARDA”. Whereas in the past initiatives for CBRN threats and Pandemic Flu were independent projects within BARDA, and BioShield was used for high risk acquisition tasks, these have all been integrated under the new BARDA strategy. During both this and a later presentation, Robinson described BARDA’s interest in the possibilities of personal preparedness. He described the progress made on small medical kits (MedKits) containing doxycline to treat anthrax that could be stored by individuals in their homes in case of an emergency. He also discussed the plans for influenza-focused antiviral MedKits. On what became the hot topic of the day, Robinson solicited input from the board on the issues surrounding home stockpiling, whether it is safe, effective, and worthwhile. He also asked for input on what should be the  right balance of government and personal strategies for preparedness.

Later in the day Robinson continued the discussion of personal preparedness and invited comments from Richard Besser of the CDC and Boris Lushniak of the FDA. Besser and Lushniak discussed public safety issues with personal stockpiling as well as some of the underlying problems with antibiotic resistance, drug expiration, product labeling and other regulatory issues.

In their December meeting, the NBSB had expressed an interest in biosurveillance. To address this, Capt. Daniel Sosin of the CDC briefed the board on the draft National Biosurveillance Strategic Plan. The NBSB has also indicated a concern for vulnerable populations in the event of pandemic of other major public health emergency, and therefore invited Susan Cooper from the Tennessee Department of Health to come and talk about this issue. Cooper gave an overview of the Association of State and Territorial Health Officials (ASTHO) Guidance document on “At-Risk Populations and Pandemic Influenza: Planning Guidelines for State, Territorial, and Local Health Departments”.

The NBSB also heard from C. Norman Coleman from the Radiation Research Program at HHS and Richard J. Hatchett from the Radiation Countermeasures Research and Preparedness program at NIAID. Coleman presented some of the strategies within the Radiation Management System and Hatchett discussed providing support services for radiation countermeasures product development.

Amy Patterson, executive director of the National Science Advisory Board for Biosecurity (NSABB) provided an overview of NSABB efforts to the NBSB. The NSABB has a similar mandate as the NBSB, and has been working since 2005 on issues of dual-use research of concern. Patterson focused on the NSABB’s recent recommendations on synthetic genomics and their draft oversight framework for dual-use research.

Throughout the day the Chairs of the working groups which were formed in December (Pandemic Influenza, U.S. Government Medical Countermeasures Processes for CBRN Agents, Markets and Sustainability, and Disaster Medicine) gave progress reports. In addition, a new subcommittee on Disaster Mental Health was introduced.

Finally, the NBSB discussed their recommendations and future activities. The members expressed interest in looking more carefully at the issue of personal preparedness. To this end it was decided that a working group be formed to deal specifically with the issue. It was also decided that no formal recommendations be made to Secretary Leavitt at this time, however, they would ask the Secretary to review the comments made by individual members on the topics of personal preparedness and home stockpiling during the meeting.

The next NBSB meeting will be held in November 2008.

To begin the day the NBSB listened to presentations from each of the members of the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE). The Enterprise is coordinated within HHS by the Assistant Secretary for Preparedness and Response and includes the NIH, CDC, FDA and BARDA. PHEMCE’s role in HHS is to coordinate the research, development, acquisition and deployment of medical countermeasures to chemical, biological, radiological or nuclear (CBRN) threats. Many of the topics the NBSB will consider and provide recommendations on will fall within the PHEMC Enterprise, so the board heard a representative from each of the agencies describe their efforts and role in PHEMCE. The morning session ended with presentations from Bruce Gellin giving an overview of the HHS pandemic flu program and Robin Robinson detailing BARDA’s pandemic preparedness and response activities.

During the afternoon session the board got down to business. After being presented with information on the possible topics that they were considering, the NBSB voted for 4 specific topics and formed subcommittees for each.

First the NBSB wanted to address the issue of pandemic influenza preparedness. The subcommittee will evaluate current research, identify the gaps, and then report to the whole board to begin making recommendations.

The second subcommittee will review the US government research portfolio to determine whether efforts are as integrated as they could be. They too will return their findings to the whole board with the goal of making recommendations to increase collaboration and avoid duplication of efforts.

The third subcommittee was commissioned to look at disaster medicine. They will take HSPD-21 as a framework for evaluation and further development of a national disaster medicine plan. It will include the possibility of promoting ‘disaster medicine’ as a new discipline and setting up dedicated training courses and programs.

Finally, it was agreed that a subcommittee be set up to look at the gaps in the medical countermeasures marketplace. This subcommittee will focus on the private sector and look at ways to engage their involvement in countermeasures development.

It was also agreed that the issue of special and at-risk populations and the issue of communications and data interoperability not be stand alone topics. They will be integrated into each of the four subcommittees and a decision to exclude them would need to be explicitly justified.

Finally the members of the NBSB volunteered their placement on subcommittees within their areas of expertise and subcommittee chairs were appointed. Andrew Pavia will chair the pandemic influenza subcommittee, Patrick Scannon; the government research evaluation subcommittee, Jim James; the disaster medicine subcommittee and John Parker; the gaps in countermeasure marketplace subcommittee. The NBSB will meet again in 6 months to hear reports from the subcommittees and make recommendations.

Written with Cheryl Vos

The same day that President Bush signed the Pandemic and All-Hazards Preparedness Act into law, the government canceled their contract for the production of 75 million doses of anthrax vaccine. The contract, with VaxGen, was the most significant from the much criticized Bioshield program. But the cancellation was anticipated by many after VaxGen, who has never brought a vaccine or drug to market missed several deadlines and, most recently, had their application for testing their vaccine in humans rejected by the FDA.

The company only has one other product in its pipeline, a new smallpox vaccine, but they do not have a contract to produce it. So, after shelling out approximately $175 million of its own cash, they have been left at the table with the bill. This scenario is precisely why no large pharmaceutical companies bid on the anthrax vaccine contract when it was offered. It was simply too much of a gamble. Granted, VaxGen’s 5 year time line for production of a next generation vaccine was overly ambitious by most standards, and they have no one to blame but themselves for signing a contract that there was little chance of completing on time.

The US will continue to stockpile the previously available anthrax vaccine from Emergent BioSolutions even though its safety has been a topic of concern for some time and that it has to be delivered in several doses over 6 months.

The cancellation of the contract and the passing of the Pandemic and All-Hazards Preparedness Act represent a welcome step back and reevaluation of how the US has been approaching countermeasure development. Amongst several provisions, the act calls for a reorganization of the Bioshield program and establishes the Biomedical Advanced Research and Development Authority, or BARDA, under the Department of Health and Human Services, which will be tasked with organizing vaccine and therapeutic development for potential bioterror agents. Having a more organized and accountable system for spending the $5.6 billion dollars in Bioshield funding will most certainly be a step forward.

Earlier this month, Representative Mike Rogers (R-MI) submitted the House version (H.R.5533) of the `Biodefense and Pandemic Vaccine and Drug Development Act of 2006′ (BARDA). The bill was introduced in the Senate by Senator Richard Burr (R-NC) (S.2564). The two bills are essentially the same with the exception of two controversial sections included in the Senate, but not the House version. Section 5: Orphan Drug Market Exclusivity for Countermeasures Products and Section 7: Collaboration and Coordination.

The Market Exclusivity section Amends the Federal Food, Drug, and Cosmetic Act to extend the period of market exclusivity from seven years to ten years for certain new drugs, antibiotics, or anti-infective drugs to treat a rare disease or condition caused by a biological agent, toxin, chemical, radiological, or nuclear agent that is deemed by the Secretary to be a material threat to the United States.

The Collaboration and Coordination section provides an antitrust exemption for: (1) meetings and consultations held by the Secretary among persons engaged in the development of countermeasures or pandemic or epidemic products; and (2) agreements resulting from such meetings.

See the extended entry for the full text of Sections 5 and 7.

Here I detail the two major pieces of biosecurity legislation up for consideration by Congress this year, S.1873, The Biodefense and Pandemic Vaccine and Drug Development Act of 2005 and S.1880, The National Biodefense and Pandemic Preparedness Act of 2005. They both address similar issues relating to the nation’s ability to develop countermeasures against emerging public health threats including bioterrorism agents and avian influenza. However, there are fairly significant differences between them. My understanding is that the Republicans and Democrats have not gotten together to discuss these two bills yet. Please feel free to get in touch with me directly if you have any questions. mstebbins@fas.org