HHS, DHS officials defend cooperative efforts

Two agencies must work together under last year’s Project Bioshield law, designed to increase U.S. supply of countermeasures to biological, chemical and radiological agents.

The Homeland Security and Health and Human Services departments are cooperating well and moving as quickly as they can in efforts to boost the nation's stockpile of countermeasures to weapons of mass destruction, officials from the two agencies said Tuesday in response to legislators' concerns.

The two agencies have distinct responsibilities but also must work together under last year's Project Bioshield law, designed to increase the U.S. supply of countermeasures to biological, chemical and radiological agents, mainly by guaranteeing drug makers a government market for the products.

The state of communication between the agencies on the program is "an absolute disgrace," ranking Democrat Bill Pascrell (N.J.) said this morning at a hearing of the House of Representatives Homeland Security Subcommittee on Emergency Preparedness, Science and Technology.

Officials, however, said the relationship was working well.

"I actually think, in this case, we may be dealing with an exemplary process," said John Vitko, biological countermeasures director for the Homeland Security Science and Technology Directorate, when asked by subcommittee Chairman Pete King (R-N.Y.) about the cooperation.

Vitko laid out the steps involved in identifying and eventually procuring countermeasures, which he said entail intense cooperation between the two departments. The process begins with threat assessments of agents by Homeland Security and, if warranted, results in development and acquisition efforts by Health and Human Services.

"Once a material threat determination has been issued" by Homeland Security, he said, "the HHS then assesses the potential public health consequences of the identified agent, determines the need for countermeasures, evaluates the availability of current countermeasures and the possibility of development of new countermeasures" and, if warranted, initiates acquisition processes.

"Throughout this process, DHS works very closely with HHS," Vitko said.

To date, Homeland Security has issued threat-level determinations for anthrax, smallpox, botulinum toxin and radiological and nuclear devices. Vitko said assessments of plague, tularemia, radiological devices and nerve agents would be completed by year's end. At the other end of the process, Health and Human Services has so far awarded contracts for two anthrax vaccines and for pediatric potassium iodide.

"There is an enormous level of cooperation among us," said Stewart Simonson, Health and Human Services' assistant secretary for public health and emergency preparedness. "It's been getting better, and I think it's pretty good right now, frankly."

Simonson added that cooperation would intensify over time, as the priorities for countermeasure work become less clear.

"In many ways, anthrax and smallpox represent the low-hanging fruit for medical countermeasure research, development and acquisition," he said. "There was consensus that these were our highest priorities, and we had countermeasures available or relatively far along in the development pipeline to permit acquisition."

Now, "given an almost endless list of potential threats with finite resources to address them," he said, "prioritization is essential to focus our efforts. We rely heavily on our interagency partner, the Department of Homeland Security, to provide us with a prioritized list of threats along with material threat assessments."

The top Democrat on the full Homeland Security Committee, Bennie Thompson (Miss.), questioned the pace of the countermeasure program, asking why Homeland Security had over the past year issued "only" four material threat determinations. The Centers for Disease Control and Prevention, Thompson said, maintains a list of more than 60 agents that Homeland Security must review.

Although the officials did not respond directly to Thompson's presentation of those numbers, Simonson said drug development, approval and production can go only so fast.

"The process of defining required specifications for a countermeasure often reveals few if any candidates in the pipeline," he said. "Basic research and early development efforts, even when robustly funded, often take years before a concept is mature enough for advanced development. The development of medical products … is a complex, lengthy and expensive process."