House Government Reform Committee Raises Concerns About ‘Project BioShield’
Members of the House Government Reform Committee at a hearing on Friday expressed general support for "Project BioShield," a program proposed by President Bush to improve the nation's defense against bioterrorism, but raised concerns about some provisions of the program, CongressDaily reports (Heil, CongressDaily, 4/4). Under Project BioShield, which Bush announced in his State of the Union address in January, the federal government would provide $6 billion over 10 years to create and produce vaccines and medications for anthrax, Ebola, plague and other biological agents. The government would guarantee pharmaceutical companies a purchaser for the products, which they have not developed or manufactured in the past because of concerns over the lack of a market for them. In addition, the FDA would have the authority to recommend the use of vaccines and medications in the event of a bioterrorist attack, regardless of whether the agency had approved the products for general use (California Healthline, 3/20). Rep. Henry Waxman (D-Calif.), ranking member of the committee, said the provision that would waive FDA approval for some medications and vaccines could lead to "the widespread distribution of unapproved drugs." In addition, he said that the program would limit the ability of the government to file suit against pharmaceutical companies over contract violations. Committee member Rep. Christopher Shays (R-Conn.) said, "Hasty acquisition of medical countermeasures available within five years, as proposed in BioShield, is a short-term bandage to a long-term illness." HHS officials defended the program but agreed to work with lawmakers to address their concerns. Dr. Anthony Fauci, head of the National Institute for Allergy and Infectious Diseases at NIH, said, "We are willing to work with the committee and other experts to find the right framework." FDA Commissioner Dr. Mark McClellan said he would work with lawmakers to "tailor the language appropriately" in the provision that would waive FDA approval for some medications and vaccines. A Senate bill (S 15) that would authorize Project BioShield could reach the floor as early as next week (CongressDaily, 4/4).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.