Senate Approves $5.6B in Funding for Prevention Against Bioterrorist Attack

The Senate on Wednesday unanimously approved a bill that would provide $5.6 billion over 10 years to fund Project BioShield, a program that encourages the development of medications and vaccines to treat U.S. residents in the event of a biological, nuclear, radiological or chemical attack, the New York Times reports (Stolberg, New York Times, 5/20). President Bush first announced Project BioShield in his 2003 State of the Union Address. The legislation would authorize funds to encourage pharmaceutical and biotechnology companies to work with NIH to develop anecdotes, vaccines and other products to treat and protect against anthrax, smallpox, botulism, plague, Ebola virus and radiation from "dirty bombs" (Dewar/Gillis, Washington Post, 5/20). Under the bill, the federal government would guarantee 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 (New York Times, 5/20). The legislation also would allow for the emergency distribution of such products before they received FDA approval (Schaefer Munoz, Wall Street Journal, 5/20). In such cases, the government would inform individuals about the risks and benefits of unapproved products, after which time individuals could decide to refuse treatment (Washington Post, 5/20). The bill would provide $890 million in funds for Project BioShield this year and as much as $3.4 billion over the next four years (Kemper, Los Angeles Times, 5/20).

Differences With House Version
The House passed a version of the bill in July 2003; lawmakers must resolve differences in the legislation before the bill can move to Bush for consideration. According to the Journal, the legislation was "bogged down" in the Senate in part because of concerns about which federal agency would administer the program and about whether U.S. military personnel would have to receive experimental vaccines (Wall Street Journal, 5/20). The Senate version does not include liability protection for pharmaceutical and biotech companies (New York Times, 5/20). The legislation also does not include a provision in the House version that would allow the government to assume the production of products in an emergency (Rovner, CongressDaily, 5/19). According to the Post, House leadership aides said that the House plans to accept the Senate version of the bill and will pass the legislation later this week, or in early June (Washington Post, 5/20). Senate Health, Education Labor and Pensions Committee Chair Judd Gregg (R-N.H.) said, "I expect the House to hopefully take our bill and move it on to the president" (CongressDaily, 5/20).

Reaction
Sen. Edward Kennedy (D-Mass.) said, "BioShield is a major step toward giving the nation's health care professionals the support they need to respond to attacks with biological, chemical or nuclear weapons" (Wall Street Journal, 5/20). HHS Secretary Tommy Thompson said, "We are going to be able to push the industry in order to do research in particular areas, and then we're going to be able to provide them with a market after they find the kind of remedies and solutions that we need" (Holland AP/Boston Globe, 5/20). According to CongressDaily, "it remains unclear" whether Project BioShield would attract the participation pharmaceutical and biotech companies. A spokesperson for the Biotechnology Industry Organization said that the bill should include liability protection and that the legislation may not guarantee funds over an adequate period to move products from development to the market. "It is an improvement, but when you consider that it takes 10 to 15 years to develop a product, it may still fall short," the spokesperson said (CongressDaily, 5/19).

BioShield II?
According to the San Diego Union-Tribune, "The ink probably won't be dry" on the signed Project BioShield bill "before lawmakers offer a new legislative package." A lobbyist who helped draft the legislation said that he expects legislators to introduce a bill called "BioShield II" to address the concerns of pharmaceutical and biotech companies. A provision in the new legislation "likely to spark debate is a proposal to allow a drug company that develops a BioShield medicine to extend the patent on one of its other commercial drugs," the Union-Tribune reports (Crabtree, San Diego Union-Tribune, 5/20).

NIH National Institute of Allergy and Infectious Diseases Director Anthony Fauci on Wednesday answered questions about Project BioShield in an "Ask the White House" chat. The complete transcript of the chat is available online.