Global Security Newswire

The U.S. Health and Human Services Department yesterday declared that a major program intended to prepare the country for a biological weapons attack would be overhauled with a focus toward decreasing the length of time it takes to produce new medical countermeasures, the Los Angeles Times reported (see GSN, July 14).

"We aren't generating enough new products," HHS Secretary Kathleen Sebelius said. She attributed the lengthy time it takes for medical discoveries to be turned into commercially available vaccines and treatments on "leaks, choke points and dead ends."

The $1.9 billion program revamp is to include improvements to the countermeasure production process that could reduce by weeks the time required to manufacture flu vaccines as well as several changes to the process for identifying encouraging research and moving candidate drugs quickly through the medical development pipeline.

As part of the overhaul, $678 million would be allocated to establish one or more private institutions that would collaborate with small firms on the production of new treatments, establishment of new production systems and manufacturing of vaccines during times of extreme demand. Another $822 million would go toward efforts to decrease the amount of time required to produce pandemic flu vaccines.

The planned reforms appear to be a tacit admission by federal authorities that the $5.6 billion Project Bioshield has failed to adequately meet the goals of speeding along the development of treatments, vaccines and medical processes to be used in a potential bioterrorism or other WMD attack, according to the Times.

House legislation introduced this year could have slashed the Bioshield fund by $2 billion in order to address unrelated budget issues. White House spokesman Nick Shapiro said Bioshield and the agency that oversees the program, the Biomedical Advanced Research and Development Authority, are still key parts of the nation's biodefense efforts but that "we are now finally creating conditions that will enable their success" (Andrew Zajac, Los Angeles Times, Aug. 20).

The planned changes were addressed in a report issued yesterday, "The Public Health Emergency Medical Countermeasures Review: Transforming the Enterprise to Meet Long-Range National Needs."

Sebelius said the Health and Human Services Department is "working toward a nimble, flexible capacity to produce countermeasures rapidly in the face of any attack or threat, known or unknown, including novel naturally occurring infectious diseases," the Center for Infectious Disease Research and Policy reported.

"Too many of our facilities are filled with big equipment that's designed to produce just one product over and over," Sebelius said at a press conference. "That works for seasonal flu vaccine, but it's not good for something we don't use regularly or haven't invented yet."

Roughly $170 million is to go toward improving Food and Drug Administration regulatory efforts, said HHS Assistant Secretary Nicole Lurie. Officials at that agency are today using "science that's decades old" to assess highly advanced treatments, Sebelius said.

Margaret Hamburg, FDA commissioner, said the HHS branch would take steps to eliminate obstacles that could slow the pace of the countermeasure review process.

Another $33 million has been allocated for initiatives at the National Institute of Allergy and Infectious Diseases to turn scientific breakthroughs into medical countermeasures, Lurie said.

BARDA officials have been assigned to oversee the establishment of new flexible manufacturing facilities as well as the refurbishment of old centers to meet the development and production needs of small-scale bioresearch firms, agency Director Robin Robinson said (Center for Infectious Disease Research and Policy release, Aug. 19).

Meanwhile, the Centers for Disease Control and Prevention yesterday announced the allocation of $698.2 million in fiscal 2010 HHS funding to 62 public health departments located in each of the 50 states, eight territories as well as New York City, Los Angeles County, Chicago and Washington, D.C. The funds are to be boost the emergency preparedness efforts of local and statewide agencies (Centers for Disease Control and Prevention release, Aug. 19).