BNA's Health Care Daily Report
December 7, 2006
The Senate Dec. 5 approved by voice vote a biodefense bill (S. 3678) that would improve the ability to quickly develop countermeasures to pandemic flu and bioterrorism, according to its supporters.
The measure now goes to the House. An aide to Sen. Richard M. Burr (R-N.C.), a leading sponsor of the bill, told BNA that sponsors are hopeful the House will pass the Senate's bill before adjourning for the year.
The House already has passed its own biodefense bill (H.R. 5533), but the House version is less comprehensive than the Senate bill. Both bills would establish a new federal agency called the Biomedical Advanced Research and Development Authority (BARDA) that would allow vaccine makers to be paid sooner for developing medicines for national emergencies. BARDA would be part of the Department of Health and Human Services.
Passage of the Pandemic and All-Hazards Preparedness Act in the Senate was praised by the Biotechnology Industry Organization (BIO), which urged the House and Senate to reconcile their different proposals quickly.
A statement from Burr's office said the Senate bill would enable HHS to work with universities, research institutions, and industry to bring more and better medical countermeasures to the public faster in case of an emergency, such as a flu pandemic.
Burr's bill would reauthorizes the Public Health Security and Bioterrorism Preparedness and Response Act of 2002; it also builds on the Project BioShield Act of 2004 to accelerate advanced research and development of drugs and vaccines, according to his statement.
The Senate bill, according to Burr's office, identifies the Department of Health and Human Services secretary as the lead federal official responsible for public health and medical response to emergencies "which will help eliminate confusion and chaos, and increase accountability and predictability." The bill also would unify HHS work under a re-named Assistant Secretary for Preparedness and Response, "which will ensure someone in the federal government, is constantly improving the country's preparedness." In addition, the Senate bill would move the National Disaster Medical System from the Department of Homeland Security to HHS.
For state and local governments, the Senate bill would reauthorize over $1 billion per year in federal funding through grants from HHS for public health and medical preparedness.
According to a summary of the Senate bill by the law firm McKenna, Long, & Aldridge, which is lobbying for passage of the bill in the House before scheduled adjournment Dec. 8, a key Senate bill provision gives BARDA the authority to directly invest in medical countermeasure advanced research and development to bridge the "valley of death"--the period between early-stage research and final product development where most new products fail. Currently, many promising countermeasures are not making it through the "valley of death" and never reach the point of eligibility for procurement by Project BioShield, the summary said. The bill authorizes over a billion dollars for advanced research and development over 2007 and 2008.
In a Dec. 6 statement, BIO President and Chief Executive James C. Greenwood said that through the BARDA authority in HHS, contracts and grants for advanced research and development will be made to companies working on products to protect the American people.
"Significantly, the Senate-passed bill contains strong funding levels and important provisions to permit competing companies to cooperatively respond to government-declared emergencies without violating antitrust laws," Greenwood said.
In a statement, HHS Secretary Michael O. Leavitt commended the Senate for passing S. 3678. "This bipartisan legislation complements important work that we have already begun to improve the BioShield program, as well as our overall preparedness against the threats of pandemic flu and bioterrorism."
Leavitt said the Senate measure is a complement to HHS's efforts on biodefense. The bill "also supports our efforts to improve coordination of preparedness and response programs across the department."