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Congress approves 'Bioshield' legislation

By Joe Fiorill, Global Security Newswire

Congress approved legislation that would guarantee a government market for medical countermeasures against a biological, chemical, radiological or nuclear attack.

The chamber voted 414-2 in favor of a bill to implement Project Bioshield, which President George W. Bush first proposed in January of last year. The Senate passed identical legislation May 19. Bush is expected within a week or two to sign the bill, which is intended primarily to spur production of drugs that manufacturers would otherwise find unprofitable.

Select Committee on Homeland Security Chairman Christopher Cox, R-Calif., called the passage "a watershed in our mission to defend America against bioterrorism, establishing our first line of defense against biological weapons."

"This is the most significant first-responder program in our nation's history. It will ensure that we have treatments immediately on hand to save lives," Cox said.

Besides authorizing the government to spend $5.6 billion over the next decade on countermeasures produced by private drugmakers, the act would speed National Institutes of Health countermeasure research and development, as well as allow the Food and Drug Administration to approve new drugs more quickly during emergencies.

A $700 million contract for a new anthrax vaccine, the first contract under the new law, is likely to be awarded "as soon as next month," said Rep. Jim Turner, D-Texas, the top Democrat on the House committee.

"By bringing researchers, medical experts and the biomedical industry together in new and innovative ways," Bush said in a statement today, "we will not only help protect the homeland but also gain insights into other diseases. This will break new ground in the search for treatments and cures while strengthening our overall biotechnology infrastructure."

Lawmakers Take "First Step," Eye Long Road Ahead

The measure passed with nearly unanimous bipartisan support, but representatives from both parties cautioned that it is only a first step in bolstering the country's biological defenses. Several outside experts and industry representatives agreed.

"From the beginning of this process," Turner said, "I have been concerned that this legislation will not be enough. Project Bioshield is an experiment. We do not know if the incentives in this bill will drive our pharmaceutical industry to develop medicines for biodefense when they can make so much more money on other products."

Seeking to plug another perceived gap in the Bioshield plan, Turner and other Democrats in May introduced a bill seeking to shorten the time needed to produce countermeasures against new agents. The Democrats said at the time that Bioshield would not address the threat of future pathogens that could be engineered to resist existing drugs.

Rep. Christopher Shays, R-Conn., said Wednesday that "implementation of Bioshield must be linked to the threat," with spending guided by a list of high-priority pathogens maintained by the Centers for Disease Control and intelligence agencies.

"The success of Bioshield also depends upon broader biopreparedness priorities," Shays added. "Massive caches of stockpiled vaccines, antibiotics and drugs," he said, "will protect no one if they cannot be administered quickly and safely. Public-health capacity is a critical enabler to Bioshield success."

Executive Director Shelley Hearne of the Trust for America's Health, a nonpartisan advocacy group, expressed similar sentiments today. "While we feel that Bioshield is an important and laudable step toward better preparedness," Hearne said through a spokesman, "we also need a simultaneous upgrade on distribution systems and work-force shortages. We need to shore up the full spectrum of our bioterrorism and public-health capabilities in order to really improve our readiness."

American Public Health Association Executive Director Georges Benjamin said Bioshield "will serve as a good way of funding cutting-edge research in a time of extraordinary need." In an interview Thursday, Benjamin expressed optimism that Bioshield will prove flexible enough to address broad public-health concerns in addition to drug procurement.

"It makes no sense to create a new vaccine and then not figure out how to get people to take it," Benjamin said.

Some drug makers also highlighted the work left to be done after passage of the measure, calling in particular for special legal protections for the government's vendors. Congress is preparing legislation known as "Bioshield 2" that could set limits on the legal liability of drug makers whose government-purchased products are said to cause harm to users.

In an e-mail Thursday, Pharmaceutical Research and Manufacturers of America spokesman Court Rosen called for "meaningful product liability protection for products specifically designed to be used (or used in new ways) to combat bioterrorism threats, as well as procurement provisions that more closely resemble the competitive private market in which the biotechnology and pharmaceutical industries ordinarily operate."

Democrats Slam Previous Bush Biological-Defense Efforts

Rep. John Shadegg, R-Ariz., said Wednesday that although the Bioshield act is not "perfect ... I do not think we will hear anyone take to the floor and say that this is not a bicameral, bipartisan proposal to address a serious threat to this nation."

Democrats nonetheless took the opportunity to blast the Bush administration for what they called the failure of previous efforts to protect the United States against potential WMD attacks.

Turner called on Congress for "vigorous oversight" of Bioshield implementation, criticizing the Bush administration for past "biodefense failures." He cited the administration's civilian smallpox vaccination program, which he said has vaccinated only about 10 percent of its goal of 500,000 health care workers.

"We need to be asking now, before the ink is dry on this [anthrax-vaccine] contract, 'What's the plan? How does this vaccine fit into our biodefenses?'" Turner said.

"Given the failure of the smallpox vaccination program, do we really expect our citizens to be any more receptive to an anthrax vaccine?" he asked.

Shadegg said simply readying countermeasures can serve as a deterrent against an attack.

"If al Qaeda knows that we are unprepared for a chemical, a biological or a radiological attack," he said, "then they are incentivized to make that kind of attack. On the other hand, if they know that we have invested the money and done the research and we have developed countermeasures ... then they are discouraged to even make that kind of attack."