Congress approves bioterror vaccine bill

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Lawmakers who experienced the dangers of anthrax firsthand sent President Bush legislation Wednesday to give private companies $5.6 billion in incentives to develop antidotes to biological and chemical weapons.

Lawmakers who experienced the dangers of anthrax firsthand sent President Bush legislation Wednesday to give private companies $5.6 billion in incentives to develop antidotes to biological and chemical weapons.

“This is the largest first responder program ever enacted in American history,” Homeland Security Committee chairman Christopher Cox, R-Calif., said before the House voted 414-2 to pass the Project Bioshield Act.

Over the next 10 years, the act would give the pharmaceutical industry the financial guarantees it says it needs to research and produce vaccines and antidotes for bioterror agents. Otherwise, the industry said, such products would have little marketable value.

“What’s the incentive today to develop a vaccine for Ebola or for the plague when there is no real market for such a vaccine in this country?” asked Rep. Billy Tauzin, R-La., a chief sponsor of the legislation.

Bush expected to sign bill
Bush said in a statement that he looked forward to signing the bill, which would help protect the homeland and “break new ground in the search for treatments and cures while strengthening our overall biotechnology infrastructure.”

With the House vote, Congress completed work on legislation Bush requested in a State of the Union speech 18 months ago. Agreement between the House and Senate was delayed by a dispute over how to guarantee a steady stream of funding to drug makers without taking away Congress’ authority to make annual decisions on spending levels.

Protection against the weapons is of personal interest to many lawmakers, who have seen their offices closed and their lives disrupted twice by biological threats since the Sept. 11 attacks.

It took three months and $23 million to clean up Senate office buildings after deadly anthrax bacteria was discovered in October 2001 in the mailroom of then-Senate Majority Leader Tom Daschle, D-S.D. Hundreds of people who work in those buildings were given antibiotics such as Cipro.

Three Senate office buildings were also closed for up to a week this February after the biological toxin ricin was found in the office of Majority Leader Bill Frist, R-Tenn.

The legislation guarantees that any company that develops countermeasures to treat diseases and conditions caused by bioterrorism would have a buyer in the federal government. Also included would be antidotes for chemical, radiological and nuclear agents.

Cox said it would be the responsibility of the Homeland Security Department to assess the global threats posed by the different weapons of mass destruction, and the job of the Health and Human Services Department to implement work on countermeasures for the most dangerous threats.

'An important day in the defense of our nation'
“This is an important day in the defense of our nation,” HHS secretary Tommy Thompson said. He noted that, among its first endeavors, the act would allow the government to acquire up to 75 million doses of the new generation anthrax vaccine early next year.

California-based VaxGen Inc. and Britain’s Avecia have the leading candidates. Safety testing is under way, but the hope is that the newer type of vaccine could cut in half the number of shots now required for anthrax inoculation, with few side effects.

The bill also would accelerate the approval process for vaccines and, in an emergency, let the government distribute certain treatments before the Food and Drug Administration approves them.

In cases where the private sector does not respond to the federal incentives, the bill allows the government to operate emergency programs to research and produce vaccines.

The House passed a bioshield bill in July 2003, but Senate appropriators balked at language that would have made spending automatic, saying that would undermine their authority to oversee and determine annual spending and create an entitlement for the drug industry.

In the compromise unanimously approved by the Senate in May and endorsed by the House Wednesday, Congress agreed to spend $5.6 billion over the next decade while retaining control over how the money is appropriated.

Sen. Judd Gregg, R-N.H., who helped steer the legislation through the Senate, said the nation faces “a threat that is dramatically different from any that we have seen before.” He is already planning hearings this fall on a second Bioshield bill that would address such issues as liability.

The Pharmaceutical Research and Manufacturers of America, the drug industry trade group, said in a statement it also welcomed passage of the bill but hoped for “meaningful product liability protection for products specifically designed to be used ... to combat bioterrorism threats.”

Among the agents to be covered by Project Bioshield are smallpox, anthrax, botulism toxin, plague and Ebola.

The two votes against the bill were cast by Reps. Ron Paul, R-Texas, and Jeff Flake, R-Ariz.

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