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. [email protected]
The first bill, S.1873, entitled The Biodefense and Pandemic Vaccine and Drug Development Act of 2005 was introduced by Senator Burr (R-NC). The bill takes the unusual step of amending the Public Health Service Act to establish the Biomedical Advanced Research and Development Agency (BARDA) within the Department of Health and Human Services (HHS) thus requiring a new agency infrastructure (think homeland security). BARDA would coordinate the development of vaccines and other countermeasures to fight potential pandemic agents and bioterrorism threats.
The bill comes with a healthy dose of controversy though. First, it amends the Federal Food, Drug, and Cosmetic Act to extend the period of market exclusivity for designated countermeasure products (i.e. vaccines, anti-viral medications and antibiotics) from seven to ten years. In essence, it pays for countermeasure development by making Americans who have to take the drugs pay a premium on them for 2 years longer then they would have to otherwise. In addition, the act prohibits any lawsuits for damages related to a security countermeasure or a qualified pandemic and epidemic product with an exception for cases where willful misconduct can be proven. The controversy with that language is that it is extremely difficult to prove willful misconduct, as opposed to negligence. It also amends the Clayton Act to allow antitrust exemptions for certain meetings and agreements among companies developing products that qualify under the act. Finally, the legislation makes BARDA exempt from Freedom of Information Act (FOIA) requests, in essence, making their activities secret.
The second bill that could be considered this year is S.1880, entitled The National Biodefense and Pandemic Preparedness Act of 2005, which was introduced by Senator Edward Kennedy (D-MA). This bill addresses the same issues as the Burr bill, but takes a very different approach. Instead of setting up a new Federal Agency, it looks to steer the existing biomedical infrastructure through a National BioVenture Trust, and a new National Institute of Pathology to the NIH. The trust would be set up as a federal government corporation to administer the BioShield Act and support the development of 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. Nonetheless, there is little in the way of controversy on this one…so far.
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. Both bills will likely go through some growing pains before they make it anywhere and I hope we will see objective independent evaluations of the two proposals presented to the public by Senators Burr and Kennedy before we run headlong into these new ventures.