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Some Drug Companies Say Project Bioshield Does Not Address Important Industry Concerns From Monday, July 26, 2004 issue.

Some Drug Companies Say Project Bioshield Does Not Address Important Industry Concerns


Project Bioshield, the legislation President George W. Bush signed last week to help develop a biodefense industry in the United States, has been criticized by some of the companies it was designed to assist, the Washington Post reported today (see GSN, July 21).

While the bill authorizes the use of federal money for the purchase of drugs and vaccines, some pharmaceutical industry executives and analysts say developing medicines for use after a biological attack is a high-risk business. Despite the $5.6 billion in federal Bioshield funding, new drugs take a long time to develop, profit margins tend to be small, and the possibility of patient lawsuits if a drug fails is a major disincentive for most drug companies, they say.

“I can’t blame companies for not wanting to get involved,” said Charles Bailey, executive director of research at the National Center for Biodefense at George Mason University. “It is not a very attractive market,” he added (see GSN, June 22).

Many executives say they need complete liability protection should a drug have adverse effects or fail to protect against a pathogen, potentially leading to devastating lawsuits.

Only about 100 of the 1,000 U.S. biotechnology companies are working on biodefense efforts, the Post reported.

“Until the liability question is solved, we’re not going to see big drug companies come to the table,” said Frank Rapoport, who represents vaccine maker Aventis Pasteur SA. “They have too much to lose,” he added.

Some Washington-area executives for biodefense-related companies say Bioshield is unlikely to significantly affect their firms’ business plans.

“I don’t think companies are going to turn on a dime to start chasing this money,” said Robert Eaton, president of MdBio Inc., a Maryland trade group for biotechnology companies.

Congress is likely to address liability and other big industry concerns, said Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.

“Bioshield does not solve all the disincentives a company may have to get involved,” he said. “But it’s a very good start,” Fauci added (Michael Barbaro, Washington Post, July 26).


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