The $5.6 billion, 10-year Project BioShield program provides the drug industry with incentives to research and develop responses to bioterrorism. The legislation also speeds the approval process of antidotes and will allow emergency government distribution of certain treatments before the Food and Drug Administration has approved them.
“We know that the terrorists seek an even deadlier technology, and if they acquire chemical, biological or nuclear weapons we have no doubt they will use them to cause even greater harm,” President Bush said in the Rose Garden.
“The Department of Health and Human Services has already taken steps to purchase 75 million doses of an improved anthrax vaccine for the Strategic National Stockpile. Under Project BioShield, [Health and Human Services] is moving forward with plans to acquire a safer, second generation smallpox vaccine, an antidote to botulinum toxin, and better treatments for exposure to chemical and radiological weapons,” the president continued.
The bill tries to guarantee a market for bioterror defenses by buying and stockpiling the new drugs and vaccines to treat or protect people against such diseases as anthrax, smallpox or the plague, or against such toxins as ricin.
Without such assurances, the private sector would probably be reluctant to invest millions in products that may never be needed.
The legislation received bipartisan support in Congress. It passed the House on a 414-2 vote July 15 and the Senate passed it 99-0 in May.
“Modern terrorist threats come not just from explosions, but also from silent killers such as deadly germs and chemical agents,” Sen. Ted Kennedy, D-Mass., an author of the bill, said in a statement. “Project BioShield creates a lifesaving partnership between our government and the private sector to develop the vaccines needed to project our citizens from this bioterrorism. This bill could save millions of lives.”
Some critics of the bill said it did not provide adequate protection against lawsuits for the companies creating the drugs and vaccines. Sen. Joseph Lieberman, D-Conn., and Sen. Orrin Hatch, R-Utah, proposed a bill known as BioShield II that would provide litigation protection and additional “incentives designed to stimulate private sector biotechnology firms,” Hatch said June 9 at the Senate Judiciary Committee.