PROJECT BIOSHIELD -- INCENTIVE FOR VACCINE MAKERS



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Last Updated

30 Jan 2003

Source: Wall Street Journal, January 30, 2003

HEALTH

Project Bioshield Is Offering Incentive for Vaccine Makers

By MARILYN CHASE, Staff Reporter of THE WALL STREET JOURNAL

President Bush, in unveiling Project Bioshield, a $6 billion initiative to finance new drugs and vaccines for combating bioweapons, offered companies an incentive to develop lifesaving products that was short on details but long on hope.

Two top federal health officials cautioned Wednesday, after Mr. Bush's State of the Union speech Tuesday night, that the new funding and procurement authority may require action by Congress before being implemented.

Still, said Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, the initiative should remedy past "difficulty to get companies engaged due to the lack of a guaranteed market" for new therapies and preventive vaccines.

Project Bioshield is a three-prong effort, officials said. First, it ensures there will be secure funding, initially estimated at $6 billion over 10 years, to buy improved vaccines or drugs for smallpox, anthrax and botulinum toxin, with more funds needed for other dangerous germs such as Ebola and plague.

Dr. Fauci said the $6 billion figure was less important than the establishment of a "permanent, indefinite funding authority" for such remedies that won't be subject to vicissitudes of the annual budget cycle that would otherwise stall creation of emergency products. That should help companies persuade their boards to let them invest capital in such expensive and risky research-and-development projects, he added.

Second, the initiative gives to NIAID and sister institutes within the National Institutes of Health a streamlined authority to speed the processing of grants to support biodefense research toward new remedies.

Finally, Mark McClellan, commissioner of the Food and Drug Administration, added the move gives the FDA a formal new authority to approve use of emergency drugs and vaccines for bioterror attack "under exigent circumstances."

VaxGen Inc., a vaccine company developing a safer smallpox vaccine, called the initiative "a real shot in the arm for the vaccine business." Donald P. Francis, founder and president of the Brisbane, Calif., company, said that vaccines "are tough and expensive to develop," so he was pleased that the president "is pushing it forward."

So far, there is only one experimental therapy for one of the 13 viruses listed among likely bioterror weapons -- cidofovir, for smallpox -- said a spokesman for Indianapolis-based drug maker Eli Lilly & Co. Speeding up the development of countermeasures "could result in countless lives being protected and saved," the spokesman said.

Democratic lawmakers were skeptical. A spokesman for Sen. Edward M. Kennedy (D., Mass.) said, "The irony is that the administration has twice blocked funding for bioterrorism already."