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U.S. Senate Passes “Bioshield” Plan

By Joe Fiorill
Global Security Newswire

WASHINGTON — The U.S. Senate yesterday voted 99-0 to establish a program that would use $5.6 billion over 10 years to stimulate private-sector development of vaccines and treatments against agents such as smallpox, anthrax, botulinum toxin, Ebola and plague (see GSN, May 5).

The House of Representatives is expected to endorse the bill and pass it on for signature to President George W. Bush in short order. A Health and Human Services Department spokesman said today that the first contract under the program would be for an anthrax vaccine and is expected in “the near future.”

First proposed early last year by Bush, Project Bioshield would give the government long-term authority to buy billions of dollars’ worth of new drugs from private companies, speed National Institutes of Health research and development on such medicines and allow the Food and Drug Administration to greatly quicken its drug-approval process during emergencies. The bill would also cover some countermeasures against chemical, radiological and nuclear attacks.

Senate Health, Education, Labor and Pensions Committee Chairman Judd Gregg (R-N.H.), who played a major role in crafting compromises that led to the bill’s passage, yesterday called Project Bioshield “a major component of our defense against future terrorist attacks.”

“We need to protect ourselves and our country against the ability of these terrorists to use the weapons they can easily get their hand on to kill innocent Americans. If these Islamic fundamentalists get their hands on a biological weapon like anthrax, they will use it, and they will use it in a place like a subway station, where great numbers of people congregate,” Gregg said.

The House voted 421-2 last July to approve its own Bioshield bill, but several key House members said the Senate bill is now likely to be submitted to Bush without a formal conference to reconcile the two versions.

“It is my expectation that this will now be passed swiftly by the Senate and the House without any formal conference. … After nearly 18 months of consideration, it is urgent that the Congress send this important public health and safety legislation to the president for his signature. Our national security cannot afford to wait while terrorists act,” House Select Committee on Homeland Security Chairman Christopher Cox (R-Calif.) said yesterday, shortly before the Senate passed its bill.

The impetus for Bioshield was the drug industry’s unwillingness to develop and produce medicines for which the everyday market is small but which could become crucial in an attack. National Institute of Allergy and Infectious Diseases Director Anthony Fauci said in January 2003 that the project would “assure drug companies there will be a market for their product.”

“The medical treatments available for some types of terrorist attacks,” the White House said in February 2003, “have improved little in decades, while there has been tremendous and rapid progress in the treatment of many serious naturally occurring diseases. … The president believes that, by bringing researchers, medical experts and the biomedical industry together in a new and focused way, our nation can achieve the same kind of treatment breakthroughs for bioterrorism and other threats that have significantly reduced the threat of heart disease, cancer and many other serious illnesses.”

Biotechnology Industry Organization President Carl Feldbaum said yesterday that by passing the bill, Congress would create “the procurement structure to make product development and production financially viable.”

Compromise won out over strong objections to aspects of bills to create Project Bioshield in both chambers of Congress.

Representative Harold Rogers (R-Ky.) said last May at a Select Committee on Homeland Security hearing that Bioshield would be “chicken feed to the industry,” while Representative Christopher Shays (R-Conn.) called for more flexibility in deciding what biological threats to guard against.

“What if they [terrorists] just do the one thing we don’t have?” Shays asked.

In the Senate, opposition to the project was led by Robert Byrd (D-W.Va.), the top Democrat on the Appropriations Committee, and by Carl Levin (D-Mich.), the senior Democrat on the Armed Services Committee. Byrd withdrew his opposition after a compromise was reached on language governing how the funds would be appropriated.

Levin was still expressing reservations about the bill as late as May 7, when a spokesman said the senator sought to increase competition for Bioshield contracts and was concerned about part of the measure that could allow the military to give its members emergency-approved countermeasures without obtaining their informed consent.

Expressing support for the bill yesterday, though, Levin said he was “pleased” that the final Senate bill stipulates “full and open competition” for most Bioshield contracts. Provisions in the pending defense appropriations bill, ensures the bill “will not make it more likely that military personnel will be required to take unapproved products without their consent,” Levin said.

Although only the House had then passed legislation to create the program, Congress voted last September to fund Bioshield with $890 million for fiscal 2004. The Bush administration’s fiscal 2005 budget proposal includes $2.5 billion for Bioshield under the Homeland Security Department budget.

The first contracts are expected within months. Health and Human Services spokesman Marc Wolfson said today that the department’s Office of Emergency Public Health Preparedness is reviewing proposals for an anthrax vaccine and is likely to make an announcement “within the near future.”

“That will be the first Bioshield” contract, Wolfson said.