BURR INTRODUCING BIODEFENSE BILL

Sen. Richard Burr (R-N.C.) was expected July 17 to introduce his long-awaited biodefense bill after removing provisions that were opposed by HHS and activists, congressional sources said.

The Pandemic and All-Hazards Preparedness Act would broaden the federal government's authority to address potential bioterrorism and pandemic flu threats. Burr has been reworking his bill since last October, following severe criticism from various parties that undermined the legislation's support.

According to a draft of the bill, the legislation places HHS in charge of the nation's response to these threats. The legislation also requires the development of a national health security strategy that will be submitted to Congress every four years beginning in 2009.

The bill also requires HHS to consider how to improve medical surge capacity in local communities through the use of mobile medical equipment and federal facilities. Medical surge capacity describes the ability of healthcare systems to assist large numbers of patients in case of an emergency.

Furthermore, the bill gives the agency the authority to establish a voluntary electronic vaccine-tracking network "to track influenza vaccines that are available for distribution to providers."

What the bill no longer does is establish a new agency, the Biomedical Advanced Research and Development Agency (BARDA), to oversee bioterrorism countermeasures.

HHS Secretary Mike Leavitt had opposed Burr's proposal to create a new agency to address bioterrorism, saying a new agency would impair HHS' ability to respond to such threats. However, the BARDA provision is likely to come up in separate legislation, a congressional staffer said.

The bill also does not include an extended market exclusivity for drugs used to combat bioterrorism. The National Organization for Rare Disorders had argued that extending market exclusivity would jeopardize orphan drug development. (http://www.fdanews.com/did/5_138/)