By Kim Coghill
WASHINGTON ¿ When Sen. Edward Kennedy (D-Mass.) introduced a $3.2 billion bioterrorism bill Thursday, he said the United States has a stockpile of petroleum, so why shouldn¿t government officials stash away vaccines for threats like anthrax and smallpox?
Kennedy¿s Bioterrorism Preparedness Act of 2001, co-sponsored by Sen. Bill Frist (R-Tenn.), not only would provide for accelerated development of a smallpox vaccine, but also aid production by removing barriers faced by the private sector.
¿The anthrax attack of the past few weeks has sounded the alarm,¿ Kennedy said on the Senate floor. ¿The clock is ticking on America¿s preparedness for a future attack. We¿ve had the clearest possible warning and we can¿t afford to ignore it. We know that hundreds, even millions, of lives may be at stake and we¿re not ready yet.¿
The warning Kennedy speaks of appears to have prompted the bipartisan legislation that is written on the side of the biotechnology and pharmaceutical industry. It calls for building a stockpile of critical vaccines, pharmaceuticals and devices, as well as expanding research on biological agents and toxins.
Frist, a physician and close ally of President Bush, released a prepared statement saying, ¿Biological weapons have the potential to exact a greater toll than anything we¿ve seen in our nation¿s history.¿
Similar to legislation introduced in recent weeks by senators Ted Hutchinson (R-Ark.) and Judd Gregg (R-N.H.), the Kennedy-Frist bill would give the secretary of Health and Human Services the authority to enter long-term contracts with companies for vaccine development.
¿This is particularly important for smaller companies that are concerned that they will start working on a project ¿ let¿s say for anthrax ¿ and in a year the government will say we don¿t need it,¿¿ Michael Werner, director of government relations and bioethics counsel for Washington-based Biotechnology Industry Organization, told BioWorld Today. ¿There needs to be a long-term commitment from the government and the Kennedy-Frist bill provides it.¿
Another industry-friendly provision accommodates the use of animal studies to demonstrate efficacy in clinical trials in the event that human studies are considered unethical. The legislation provides funding for security of companies and people engaged in anti-terrorism vaccine development, and again, similar to the Hutchinson-Gregg legislation, the Kennedy-Frist bill attempts to expedite FDA review and approval times.
¿The Kennedy-Frist bill will go a long way toward improving our public health infrastructure and also will go a long way toward removing the barriers faced by private-sector companies that want to step up to the plate and develop necessary products,¿ Werner said.
The Hutchinson-Gregg legislation, referred to as the Pathogen Emergency Preparedness and Response Efforts Act of 2001 (PREPARE ACT), would give the FDA authority to designate ¿anti-bioterrorism¿ products for fast-track approval. (See BioWorld Today, Nov. 12, 2001.)
Werner characterized the Kennedy-Frist bill as being broader than the Hutchinson-Gregg legislation.
Other sections of the legislation include provisions for improvement in state and local public health preparedness, and for improvements in food safety protection against agriculture bioterrorism. If approved, the Centers for Disease Control would receive $120 million to improve training, public health laboratories and disease surveillance and response.