March 21, 2006

Sen. Richard Burr (R-N.C.) will soon introduce revised legislation to strengthen the federal government's efforts to fight bioterrorism and pandemic flu. But the bill already faces a new critic: HHS.

Burr has been reworking a bill to broaden the federal government's authority to address potential bioterrorism and pandemic flu threats since last October, following severe criticism from various stakeholders that undermined the legislation's support. Burr is a few weeks away from reintroducing his bioterrorism bill, S.1873, his spokesman Doug Heye told FDAnews.

But while Burr and proponents such as Senate Health, Education, Labor and Pensions (HELP) Chairman Sen. Mike Enzi (R-Wyo.) believe they have made the adjustments necessary to improve the bill's odds of passing, the legislation has attracted a new critic in HHS Secretary Mike Leavitt.

Leavitt used his March 16 testimony before the HELP committee to criticize S.1873, arguing it would hamper HHS efforts to ensure there are sufficient vaccine stockpiles in the event of a bioterrorism incident or pandemic flu threat. The HELP committee has jurisdiction over HHS and the biodefense issue.

Leavitt introduced his plan to reorganize the Office of Public Health Emergency Preparedness (OPHEP), giving it the authority to better integrate biodefense requirements "across the full range of threat agents, with the execution of advanced development and procurement of medical countermeasures." HHS will also work to improve interagency collaboration on biodefense issues, Leavitt said.

Burr's proposal calls for the creation of a new agency, the Biomedical Advanced Research and Development Agency (BARDA), which would coordinate and oversee bioterrorism countermeasures.

Leavitt expressed concern that establishing BARDA "would impose an organizational framework on HHS that impairs my ability to implement the strategic approach for medical countermeasures development and procurement including the functions to be executed by a reorganized OPHEP and a more efficient BioShield interagency governance process."

However, Burr and Enzi are optimistic they can work out a solution with HHS. Burr staff have already met with HHS officials and believe they can reach a compromise because "the goals that we share are the same," said Heye. Enzi's staff also will consider the HHS proposal in deciding on final language for the bill. "We will take those thoughts into account when working with Senator Burr to craft any legislation that would affect these critical public health activities," said Enzi spokesman Ryan Taylor. (http://www.fdanews.com/did)