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U.S. Officials Anxiously Await Passage of Bioshield Bill

By David McGlinchey
Government Executive

WASHINGTON — U.S. public health officials said Thursday that they anticipate Congress will soon pass the Project Bioshield legislation, a sweeping bill designed to strengthen the nation’s biological defenses and also loosen restrictions on hiring biological experts and the use of emergency drugs (see GSN, July 17, 2003).

President Bush announced the Project Bioshield effort during his 2003 State of the Union speech, but the legislation has not moved with the speed that administration officials had anticipated.

“I’m hopeful that in the spring it will pass,” said Stewart Simonson, special counsel to Health and Human Services Secretary Tommy Thompson.

HHS officials are working with lawmakers to move the bill through Congress, according to Simonson, who spoke at a meeting of the Secretary’s Council on Public Health Preparedness in Washington.

Project Bioshield “seems like it’s very near,” said D.A. Henderson, the chairman of the secretary’s council and a senior scientific adviser at HHS.

House lawmakers passed the legislation last year, but it stalled in the Senate. The main resistance to the bill has come from Senator Carl Levin (D-Mich.), who is concerned that the bill will allow the White House to dole out large, no-bid contracts. Levin is reserving his right to offer an amendment to increase competition on Project Bioshield contracts, according to his spokeswoman.

“I think we are 98 percent there, but let me tell you, that last 2 percent is something,” Simonson said.

Project Bioshield includes several major initiatives, including an almost $6 billion incentive for drug companies to develop otherwise unprofitable medicines, vaccines and countermeasures to combat biological weapons. That funding has been approved by Congress and is separate from other Bioshield legislation, according to Simonson. Still being debated on Capitol Hill are portions of the plan that allow the executive branch to use unlicensed drugs in the event of a bioterrorist attack and loosen restrictions on drug procurement and hiring at the National Institutes of Health.

Federal health officials are already hiring biological experts and passage of the legislation will only speed that process, according to Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.

“We’re already doing it, [the legislation] will just facilitate that,” Fauci told Government Executive. “We’re already bringing a lot of good people in.”

Fauci said that he wants to increase the amount of biological research that is developed into actual biological defenses. “We are looking for people with expertise in the transition zone between basic research and advanced development,” he said.

Simonson said that it is generally accepted that the White House would need permission to use unlicensed drugs in the case of an attack. That action would only be used “as a last resort,” he said. “We need to have the authority,” he added.

Simonson dismissed fears that the Bioshield program would be used as a cash cow for drug companies with political ties to the White House.

He said that procurement would be “very much out in the open. Nothing will be done under the radar screen.”