House Passes Bill To Provide $5.6 Billion for Project BioShield
As expected, the House on Wednesday voted 414-2 to pass the Project BioShield Act (S 15), guaranteeing $5.6 billion over the next 10 years for the private sector development of bioterror countermeasures and vaccines to treat U.S. residents in the event of a biological, nuclear, radiological or chemical attack, the AP/Las Vegas Sun reports (Abrams, AP/Las Vegas Sun, 7/14). President Bush announced Project BioShield in his 2003 State of the Union address. The legislation authorizes funds to encourage pharmaceutical and biotechnology companies to work with NIH to develop antidotes, vaccines and other products to treat and protect against anthrax, smallpox, botulism, plague, Ebola virus and radiation from "dirty bombs." Under the bill, the federal government guarantees the purchase of such products, which likely would not have a high demand in the private market, to provide companies with incentive to invest in their research and development. The legislation also allows for the emergency distribution of such products before they receive FDA approval. In such cases, the government will inform individuals about the risks and benefits of unapproved products, after which time individuals could choose to refuse treatment. The House passed its version of the bill in July 2003, but the Senate's legislation was delayed for nearly a year; the Senate ultimately passed the bill in May. The House passed the Senate bill in part because both chambers want to avoid a conference on the legislation. Bush is expected to sign the bill into law (California Healthline, 7/12).
The bill's passage was delayed in Senate and House negotiations for 18 months after Bush proposed the plan, "frustrat[ing]" lawmakers who said "the government and private sector must play catch-up," CQ Today reports (Schuler, CQ Today, 7/14). According to CongressDaily, final action on the plan "stalled [in the House] for reasons even backers of the relatively non-controversial measure could not fully explain" (CongressDaily, 7/15). Legislators said they were concerned that funding would not have been subject to the usual appropriations process under the original version of the bill. The final draft guarantees the full $5.6 billion will be spent on anti-bioterror programs, but grants Congress discretion over allocating specific awards from the fund, according to the San Francisco Chronicle. Drug companies had been concerned that the government might lose interest and shift funds from the program as more time passed since the anthrax attacks in 2001, according to John Clerici, a Washington, D.C., lawyer who worked on the bill as a representative for several drug makers (Tansey, San Francisco Chronicle, 7/15).
Bush said in a statement that the bill would protect the nation and "break new ground in the search for treatments and cures while strengthening our overall biotechnology infrastructure." House Homeland Security Committee Chair Christopher Cox (R-Calif.) said, "This is the largest first responder program ever enacted in American history" (AP/Las Vegas Sun, 7/14). Rep. Sherrod Brown (D-Ohio) voted for the bill, but said he was concerned that other medical research funding was being sacrificed for Project BioShield. Brown, who called for a 10% increase in NIH funding, said, "We have a responsibility to prepare the country for biological attack, but we also have a responsibility to maintain strong support for medical research." Rep. Joe Barton (R-Texas), chair of the House Energy and Commerce Committee, said that without the funding "in future years, the private sector companies capable of development won't undertake the heavy investment and risk associated with developing products" (CQ Today, 7/14).
CongressDaily reports that "the companies expected to participate in the program are not completely satisfied with it" (CongressDaily, 7/15). Companies would like to see revisions to the bill that would relieve drug makers of any liability they might face related to bioterror medications, Clerici said, adding that large drug companies will more actively seek contracts if they receive this protection. BioShield proponents have not worked to enlist larger firms such as "the GlaxoSmithKlines, the Pfizers and the Mercks," Clerici said, adding, "It's like fighting a war without Lockheed Martin, Boeing or [Northrop Gumman] supplying the government" (San Francisco Chronicle, 7/15). Sen. Judd Gregg (R-N.H.), chair of the Senate Health, Education, Labor and Pensions Committee, said he plans to work later this year on a "BioShield 2" measure to address liability and antitrust issues in the bill. Gregg also has scheduled for July 22 a hearing on bioterror preparedness (CQ Today, 7/14).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.