Legislation to bolster biodefense industry

Sen. Richard Burr, R-N.C., has plans to introduce a biodefense bill this fall that will address the medical and financial concerns faced by the pharmaceutical industry.

The National Biodefense Act of 2005 seeks to establish a new state agency - the Biomedical Advanced Research and Development Agency - and to encourage researchers, manufacturers and distributors to commit resources toward developing a national biodefense program.

Burr stated in a press release that the legislation will provide a comprehensive approach to combat outbreaks of infectious diseases.

"By establishing a single agency responsible for medical countermeasures, we will be able to develop more drugs and vaccines at a faster rate and reduce our vulnerability to potential health threats like avian flu and anthrax," he said in the release.

Brad Smith, an associate at the University of Pittsburgh Center for Biosecurity, said the biological threats faced by the U.S. - whether natural or in the form of biological weapons - could result in "large-scale, potentially destabilizing epidemics."

Biological threats also pose problems beyond a potentially substantial death toll, he said.

They could also have disastrous civic, political and economic consequences.

The new biodefense bill aims to unite experts from different fields in a common effort to prevent the uncontrolled spread of disease.

"It would work with academia and companies to make sure we could bring vaccines and other products to market," said Doug Heye, spokesman for Burr.

Besides establishing the new agency, the bill provides incentives for major drug companies to produce biodefense drugs with no market outside of government purchase, Smith said.

"Drug development is a long, involved process that's pretty risky," he said.

Heye acknowledged that drug company liability is an overriding concern.

"Two years ago we introduced BioShield, which hasn't been as successful as we had hoped in terms of bringing products to market for that reason," he said.

Smith said the Project BioShield Act of 2004 was a commendable attempt to encourage the research and production of new drugs, but it fell short in practice.

"Many felt it was an important first step but wouldn't revolutionize drug development or create a new industry," he said.

Many senators have proposed improvements in light of BioShield's shortcomings, but Burr's bill offers the most holistic solution and has the greatest general support in the Senate, Smith said.

He said BioShield created a system under which the government could agree to buy a drug once the product was complete, but was basically unable to monitor the progress of the drug.

"There was a gap from basic research to the completed product - a many-years, millions-of-dollars gap known as the 'valley of death,'" he said.

"The new agency has the ability to help companies bridge that gap."

The agency would be responsible for impacting and directing the development of a biodefense drug, providing leadership, communication and funding.

Burr plans to formally introduce the bill after the October recess with the intent of marking up the bill in committee this fall.

 

Contact the State & National Editor at stntdesk@unc.edu.