Project Bioshield Protectsthe Homeland and Product Developers

Originally Published MPMNOctober 2003

EDITOR'S PAGE

Project Bioshield Protectsthe Homeland and Product Developers


Since our country was attacked two years ago on September 11, terrorism has become a bona fide threat. Many experts say that it is not a question of whether another event will occur, but when. And another attack could affect entire cities. Its effects could even spread across the country if biological or chemical agents are used.

It is clear that the government needs to protect people and healthcare workers against such events. New medical devices, as well as vaccines and their delivery devices, have to be created to do this. 

Some companies are already starting to make such products or modify their existing ones. For example, Steris Corp. and the U.S. Army Edgewood Chemical Biological Center have entered into a collaborative R&D project that will evaluate, optimize, and modify the company's Vaporized Hydrogen Peroxide technology to demonstrate its effectiveness against biological and chemical warfare agents.

However, medical product design is a risky business even in the best of times. Bringing new devices to market can be a long and erratic process. The high costs involved in planning clinical trials and manufacturing processes can seem overwhelming to a manufacturer, especially since there is never any guarantee that the product will succeed. Also, even after a company effectively navigates through the regulatory hurdles, it may still have to deal with unpredictable reimbursement policies. 

Add to those obstacles the fact that many of the products needed in the event of terrorism have limited use. Understandably, companies might be hesitant to spend the time and money to create them, despite the obvious need. What manufacturers must have is a guaranteed buyer and expedited regulatory approval for such products.

Enter Project Bioshield. "Project Bioshield would correct this [problem]," said FDA commissioner Mark B. McClellan, MD, PhD, "by doing what bipartisan legislators agree is most needed: allowing the government to commit years in advance to paying for counterterrorism treatments that work."

In February 2003, President Bush proposed the creation of this permanent indefinite funding authority. Under Project Bioshield the government will be able to purchase medical countermeasures to terrorism as soon as experts believe that they can be made safe and effective. This is meant to ensure that the private sector devotes efforts to developing these products.

"Bioshield is a good example of how we can find policy solutions that improve access to new technologies by providing appropriate incentives for developing new products," said McClellan. 

The full House approved its version of Project Bioshield on July 16, 2003. It includes $5.6 billion over 10 years, with up to $890 million for fiscal year 2004, and $3.4 billion through 2008.

In the Senate, the Health, Education, Labor, and Pensions committee chairman Judd Gregg (R-NH) reached an agreement with Senate Appropriations committee ranking member Robert Byrd (D-WV) on September 3. This will allow the Senate version of the bill to progress. The Senate bill is estimated to cost $8.1 billion over 10 years.

Project Bioshield will do more than just prepare us for another terrorist attack. The discoveries made will also have important spillover benefits in diagnosing and treating other diseases.

Susan Wallace, Managing Editor

Copyright ©2003 Medical Product Manufacturing News