Biodefense Journal recently contacted the office of Senator Richard Burr, R-NC, Chair of the Senate Subcommittee on Bioterrorism and Public Health Preparedness concerning the legislation dubbed Bioshield II. Following are responses BJ received to its submitted questions

BJ: What were you trying to achieve with your original legislation?

Burr: First, I would like to clarify what legislation we are discussing. The Pandemic and All-Hazards Preparedness Act (S. 3678) was passed by the U.S. Senate and House of Representatives during the last week of the 109th Congress. It is on its way to President Bush to be signed into law. People refer to this legislation through many acronyms, including Bioshield II, BARDA, and others.

This legislation represents the culmination of nearly two years of bipartisan work within the Senate on the important issue of preparedness for all-hazards public health emergencies. By all-hazards, I mean chemical, biological, radiological, and nuclear threats, as well as deliberate, accidental, and natural emergencies.

I believe you are asking specifically about the provisions in this legislation that build on the Project Bioshield Act of 2004 to more quickly develop drugs and vaccines to protect against threats such as bird flu and bioterrorism. What we learned over the last two years is that even though Project Bioshield established a $5.6 billion fund to purchase biodefense countermeasures in order to incentivize big pharmaceutical companies to develop these products, it was not enough of an incentive for these companies. As a result, the only companies doing biodefense countermeasure research and development are smaller biotechnology companies. Many of these companies come up with new innovative ideas but do not have the financial capital and business savvy to get products all the way through the development pipeline. So, many products are caught in the “valley of death” between basic research funding from the National Institutes of Health, and Bioshield procurement funds.

Additionally, the process for developing a new medical countermeasure still takes up to a decade and costs hundreds of millions of dollars. S. 3678 reorganizes and enhances HHS medical countermeasure research, development, and procurement activities, through the Biomedical Advanced Research and Development Authority, or BARDA. Modeled after the Defense Advanced Research Projects Agency’s successes in defense research, BARDA will bring innovation to a process that is simply too slow to combat terrorist activities or Mother Nature. BARDA will be an aggressive venture capitalist partnering with universities, research institutions and industry on the advanced development of promising drugs and vaccines. In addition to helping bridge the “valley of death,” BARDA will help make the government more dynamic, nimble and accountable and will bring more and better medical countermeasures to the public faster in case of emergency.

BJ: Do you think the final version still achieves your goals?

Burr: Yes, I believe the improvements we made to the legislation over the last two years will empower the federal government to partner with private industry, academic universities, and research institutions in the development of new medical countermeasures, and will ensure we are better prepared to meet the all-hazards threats of the future.

BJ: What about concerns that the liability provision prevents citizens from any legal recourse?

Burr: Thank you for the question. First, let me clarify that S. 3678 does not include any provisions related to liability. Limited provisions included in the 2006 Defense Department Appropriations bill shield manufacturers, distributors, and administrators of specific medical countermeasures from liability unless they were “bad actors”. A “bad actor” has done something intentionally wrong. This section of the appropriations bill was called the PREP Act, Public Readiness and Emergency Preparedness Act. Additionally, the liability shield only applies in specific cases when the U.S. Secretary of Health and Human Services declares a public health emergency and identifies a specific medical countermeasure to be covered by the declaration. The PREP Act also includes a provision to set up a compensation program for individuals who are injured from a medical countermeasure, under these special circumstances.

BJ: Bioshield II media has emphasized drug manufacture and vaccine development. But there are provisions for grants to modernize biomedical and behavioral research facilities. Are there any guidelines on those funds? For instance, are you looking for research into bioagents themselves?

Burr: In the final legislation which passed the U.S. Senate and House, there are no new grants for modernizing research facilities. The National Institutes of Health currently funds construction of new biosafety labs across the country.

BJ: Bioshield II focuses on protections like vaccines and drugs, but genetic engineering provides a dimension not considered even a few years ago. How do you see that impacting the thrust of Bioshield II?

Burr: Advances in biotechnology and genetic engineering offer the opportunity to eliminate certain diseases but may also be put to destructive use by those who seek to harm us. The existing National Science Advisory Board for Biosecurity has been evaluating ways to prevent good science from being put to bad uses, what some call “dual use”. Additionally, I believe the model we have created in S. 3678 through the establishment of BARDA and the new National Biodefense Science Board will move the country in the right direction by identifying threats, challenges and opportunities presented by advances in biological and life sciences, and by developing more and better medical countermeasures to meet these challenges faster.

BJ: What are some of the ways you intend to monitor the implementation of the legislation to assure Congressional intent is followed?

Burr: Congress has a number of ways to oversee program implementation – from holding committee hearings, to making official inquiries, requesting briefings, and funding programs. I will work with my colleagues to ensure the U.S. Department of Health and Human Services has the resources to fully implement S. 3678, and to closely monitor its implementation.

BJ: What open forums will the general public have to monitor the implementation?

Burr: The U.S. Department of Health and Human Services has already held its first public stakeholders meeting on the development of a strategic plan for their medical countermeasure enterprise. It solicited information publicly and will be releasing the final strategic plan shortly. This is the beginning of what I hope will be a more open and transparent process of soliciting input from public and private sources. This process will enable the general public to have greater insight into the implementation of the Pandemic and All-Hazards Preparedness Act. Additionally, Congressional hearings are always open to the public and are another good way to monitor implementation.

BJ: Can we expect a later provision that seeks to monitor terrorist bioweapons development activity in order to ensure the research is heading in the right direction?

Burr: The U.S. Department of Homeland Security is responsible for evaluating material threats against the people of the United States sufficient to affect national security. Then the U.S. Department of Health and Human Services evaluates the public heath consequences of these threats and the medical countermeasures available to combat them.

BJ: The emerging threats have come quickly in the last several years. Do you expect to continue to monitor this aspect as well, particularly in areas like Asia and Africa?

Burr: As you know, naturally emerging diseases are a growing threat to public health. One only needs to look at the spread of H5N1. We must be able to identify a newly emerging disease at the earliest possible moment, and ultimately reduce its transmission. In the United States, public health departments across the country have varying abilities to identify a case of bird flu and contain its spread. The Pandemic and All-Hazards Preparedness Act establishes a set of key capabilities that all health departments must strive for, and builds the foundation for a uniform public health security system that is robust and trained to address public health emergencies. S. 3678 also modernizes how public health departments detect, respond to, and manage public health threats, by collecting instant electronic information which will enable public health officials to make informed decisions before, during, and after a public health emergency. Additionally, it strengthens the nation’s public health infrastructure by offering loan repayments to recruit and train a stronger public health workforce, capable of responding to emergencies.

[Senator Burr's Bio]