Senate Approves $5.6 Billion for 10-Year ‘Bioshield’ Project

Repeatedly invoking the threat of terrorism, the Senate on Wednesday unanimously approved a $5.6-billion, 10-year initiative to encourage private industry to develop vaccines and drugs that would protect Americans from biological, chemical or nuclear attacks.

If terrorists have access to anthrax, smallpox, botulism toxin, plague or Ebola virus, said Sen. Judd Gregg (R-N.H.), “there is no question they will use it. And they will use it in a place where people gather to go about their daily lives.”

The Senate vote came more than two years after anthrax-filled letters caused five fatalities, changed the way mail was inspected and delivered, and highlighted the nation’s vulnerability to bioterrorist attacks.

President Bush, who on Wednesday praised passage of the bill as “another important step in winning the war on terror,” proposed Project Bioshield in his 2003 State of the Union address. The House passed a bill, 421-2, last summer, but the legislation stalled in the Senate over the technical concerns of a handful of lawmakers.

To get around that impasse, Congress included funding for the initiative in this year’s federal budget. That provision allows the government to spend up to $890 million on Project Bioshield this year and as much as $3.4 billion through 2008. House leaders now have agreed to accept the Senate’s version of the legislation, and Bush could sign it into law within days.

Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, said the government already was negotiating with several companies for the production and purchase of bioterrorism countermeasures. In March, the government opened bidding on contracts to buy as many as 75 million doses of an experimental anthrax vaccine.

Fauci said that the government has stockpiled enough smallpox vaccine to treat everyone in the country and that significant progress has been made in developing four specific products: a modified smallpox vaccine, a licensed anthrax vaccine that could be administered in three doses rather than the current six, a botulism antitoxin and an Ebola vaccine.

In a rare display of bipartisanship, Republican and Democratic senators praised Project Bioshield, saying it would speed the development of anti-bioterrorism drugs and vaccines by guaranteeing private pharmaceutical and biotechnology companies a government market for their products.

Sen. Edward M. Kennedy (D-Mass.) called the bill, which he co-sponsored, “a major down payment in terms of health security for all Americans.”

The legislation also would give the government the authority to purchase and stockpile large quantities of vaccines and drugs, to be distributed to public health officials in areas after an attack by terrorists using the smallpox virus, anthrax powder or other biological agents.

The government will work with private companies to develop anti-bioterrorism products, and then “guarantee you we’ll buy it, even if we never use it,” Fauci said.

In the event of a public health emergency created by a bioterrorism attack, the legislation would suspend the Food and Drug Administration’s normal drug-approval process. It would allow the secretary of Health and Human Services to order the distribution of drugs and vaccines even if they had not been fully approved and licensed by the FDA.

But lawmakers of both parties also said the nation remained unprepared for a significant bioterrorism attack.

“We are still not appropriately prepared against biologic agents,” said Senate Majority Leader Bill Frist (R-Tenn.), describing them as dangerous substances that “you can’t see, you can’t touch, you can’t smell, you can’t hear.”

Kennedy cited recent reports by the General Accounting Office, the investigative arm of Congress, and the nonprofit Trust for America’s Health on the failure of hospitals and public health agencies to prepare for bioterrorism attacks. “We still have a great ways to go,” he said.

The Senate’s passage of Project Bioshield is good news to the biotech industry, because about 100 companies are believed to have anti-bioterrorism products in the research and development pipeline.

Robert Marsella, a vice president for San Diego-based Hollis-Eden Pharmaceuticals, said Project Bioshield would spur its development of a drug to treat radiation sickness. “Our contractors are on hold right now, waiting to ramp up production,” pending FDA approval, he said.