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Biotech officials pan implementation of Project Bioshield

HHS accused of moving too slowly to issue contracts for vaccines and treatments under the program.

The program Congress established to speed commercial development of vaccines and treatments to counter a potential bioterror attack is moving too slowly, biotechnology industry officials told lawmakers Thursday.

While Congress is already considering legislation to expand "Project Bioshield," lawmakers and companies agreed implementation of the original plan might be hitting snags.

During a hearing of his panel, House Government Reform Committee Chairman Tom Davis, R-Va., noted the government has entered into three contracts for countermeasures under Bioshield.

"In spite of these efforts, there remains concern that [the Health and Human Services Department] is moving too slowly to award contracts and has made insufficient efforts to stockpile existing countermeasures while new and improved ones are being developed," Davis said.

Companies had harsher words about BioShield. Under the program, HHS is supposed to identify potential threats and encourage industry to produce medical countermeasures.

The theory is companies will develop vaccines and other products for which the government would be the only likely purchaser, as long as they know there is a market. Without incentives, the government might lack a sufficient supply of treatments or vaccines for bioterrorism threats such as anthrax, botulism and Ebola.

But firms said HHS is not moving quickly enough to identify threats, and that the procurement process is flawed.

HHS has not implemented procurement policies under BioShield in a way that will expand the number of companies manufacturing countermeasures, said Robert Kramer, president and chief executive of BioPort Corp. "Project Bioshield has come up short," Kramer said, adding his company is not sure it can continue to make its Food and Drug Administration-approved anthrax vaccine without more assurance the government would buy it.

Richard Hollis, chairman and CEO of Hollis-Eden Pharmaceuticals, said Bioshield is not being used to send signals to encourage investment from private capital markets in companies that are making countermeasures.

"Bioshield has increasingly appeared to be reverting back to a more traditional government-funded research and development model," Hollis said. "As a result the breadth of technology, knowledge and discovery that will be focused on safeguarding this nation will be only a fraction of what a broader, private sector-based program would provide."

Government health officials, however, told lawmakers that they have taken important steps to boost countermeasure research and manufacture.

Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said there had been "substantial progress" on that goal.

HHS awarded a contract to VaxGen for up to 75 million doses of a new anthrax vaccine, a contract to BioPort for 5 million doses of its approved anthrax vaccine and a contract for pediatric potassium iodine, which is used after radiation exposure to prevent cancer.

Congress is planning a second installment of Bioshield legislation, aimed at further encouraging companies to develop drugs by lifting their liability.