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Congress seeks to stimulate market for bioagent vaccines

Government Executive
By Chris Strohm

Legislation will be introduced early next year as part of an ongoing effort to stimulate private sector development of medical vaccines and countermeasures to protect against biological pathogens, officials said Wednesday.

Congressional officials plan to introduce legislation for Project Bioshield II in February, said Chuck Ludlam, counsel to Sen. Joe Lieberman, D-Conn., ranking member of the Senate Governmental Affairs Committee.

"It will be the most ambitious, aggressive set of legislation on the development of drugs for infectious diseases ever introduced, or even contemplated," Ludlaw said Wednesday at a forum in Washington sponsored by Equity International.

Government and industry officials at the forum said the nation is woefully unprepared for a biological attack, despite the growing awareness of bioterrorism threats.

"We are totally unprepared medically for one of these attacks," Ludlaw said.
Last July, President Bush signed into law Project Bioshield, which is a $6 billion program to create and expand the nation's stockpile of vaccines and treatments to combat potential bioterrorism agents.

Ludlaw said the program is "a step in the right direction," but what it encompasses "is not remotely enough." Bioshield II will probably have 30 titles, he said, adding that a draft of the legislation should be completed by the end of this week.

Although there has been speculation that the Homeland Security Department will be given lead responsibility for Bioshield II, Ludlaw expects Congress to leave the program in the hands of the Health and Human Services Department.

Jerome Hauer, former HHS acting assistant secretary for the office of public health emergency preparedness, agreed with Ludlaw's assessment that Project Bioshield has not achieved its potential.

"Bioshield I was a good start; there's no question about it," Hauer said. "It was intended to engage the industry [and] to stimulate the industry. ... But it appears to have had just the opposite effect for many of the pharmaceutical companies."
Hauer said his former office, which is now run by Stewart Simonson, is not responsive to industry and not moving fast enough. He believes Bioshield should stay with HHS, but be moved to a new office.

Hauer is joining Fleishman-Hillard as a senior vice president for government relations. He also is a consultant for BioPort Corporation of Lansing, Mich., which produces the military's anthrax vaccine.

"Three years after Sept. 11, we have added virtually no new countermeasures to the national pharmaceutical stockpile with the exception of smallpox vaccine, a larger cadre of antibiotics and maybe some modest increases in the botulinum and antitoxin stockpile," Hauer said. "By and large, we have seen nothing in the way of addition of new chemical antidotes."

HHS did not provide comment by press time.

Industry efforts to develop vaccines have been stifled due to liability concerns, costs, difficulties producing enough vaccine and questions over how vaccines would be distributed, said Stephen Morse, director of the Center for Public Health Preparedness at Columbia University.

"While the number of threats continues to increase and become more dynamic, the vaccine industry has been shrinking in recent years," Morse said.

Air Force Col. Joseph Palma, director of the Defense Department's chemical and biological defense program, agreed. He said the government has not found an appropriate way to offer incentives to the pharmaceutical industry for producing vaccines. He added, however, that private corporations also need to "think very carefully about how they're going to support the national effort."

Ludlaw believes Project Bioshield II will have support in Congress. But he said the legislation's fate depends on whether the administration gets behind it.

"If the president leads, we can enact all of this," Ludlaw said. "If he doesn't, we will enact none of it."