Lawmakers question Bush 'Bioshield' plan

Proponents of President Bush's "Bioshield" plan for encouraging commercial research and production for bioterrorism defense faced bipartisan questions Friday during a hearing before the House Government Reform Committee.

Several lawmakers present said that while they supported the goals of the program, they questioned aspects of it, such as the loosening of government procurement rules and the waiver of FDA approval for certain drugs in an emergency.

"Hasty acquisition of medical countermeasures available within five years, as proposed in Bioshield, is a short-term bandage to a long-term illness," said Rep. Christopher Shays, R-Conn.

Joining in the questioning was Government Reform ranking member Henry Waxman, D-Calif., who complained that the plan limits the government's ability to sue companies that abuse contracts. Waxman also said the FDA-approval waiver could lead to "the widespread distribution of unapproved drugs."

Officials from the Health and Human Services Department defended the plan, but also agreed to work with legislators to address their concerns.

"We are willing to work with the committee and other experts to find the right framework," said Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases in the National Institutes of Health.

HHS officials stressed that the program is "results-based," meaning that pharmaceutical companies are only paid in full when they deliver a final, successful product that the Food and Drug Administration approves. FDA Commissioner Mark McClellan agreed to work with members to "tailor the language appropriately" to guide the use of drugs without FDA approval. Meanwhile, pharmaceutical companies told the committee they need more protections to conduct the risky and expensive research and development on countermeasures to bioterror weapons.

Bioshield legislation may reach the Senate floor as early as next week, after clearing committee unscathed on that side of the Capitol.