Report: For biodefense, US needs closer ties to industry

Feb 12, 2010 (CIDRAP News) – The US government needs much closer collaboration with private industry—like the arrangements used in building aircraft carriers and putting men on the moon—in order to improve the nation's medical defenses against biological, chemical, radiological, and nuclear threats, says a report from a federal advisory panel.

The 33-page report also says the government needs more centralized leadership, perhaps from a White House–level team, to improve medical countermeasures (MCM) against threats like anthrax, smallpox, and tularemia, as well as radiological weapons.

"With adequate resources and effective leadership, the various agencies of the U.S. Government can work together and harness the expertise of the private sector in ways similar to those used to produce aircraft carriers, land men on the moon, and accomplish other 'Manhattan Projects,'" states the report, which was adopted this week by the National Biodefense Science Board (NBSB). The board advises the Department of Health and Human Services on biodefense issues.

The report, titled "Optimizing Industrial Involvement with Medical Countermeasure Development," was prepared by an NBSB subcommittee called the MCM Markets and Sustainability Working Group. The document makes eight recommendation to the government, mostly dealing with more consistent funding, more coordinated leadership, and innovative partnerships with industry.

The full NBSB had assigned the working group to report on the financial, policy, and regulatory issues that limit private industry's willingness to invest in the development of drugs, vaccines, and diagnostics to counter biological and other threats. The government has been working for years, with limited success, to improve its inventory of such countermeasures. Inconsistent government support and the lack of a commercial market for those products are seen as the key barrier to their development.

The report comes just as the NBSB is getting involved in a more comprehensive review of countermeasures development, ordered by Department of Health and Human Service s (HHS) Secretary Kathleen Sebelius in December. She called for the review because of the slow delivery of pandemic H1N1 flu vaccine last fall and slow progress in the development of other countermeasures, especially a second-generation anthrax vaccine.

Sebelius assigned Dr. Nicole Lurie, HHS assistant secretary for preparedness and response, to complete a report on the countermeasures program by the end of March. Lurie has asked the NBSB to play a lead role in that effort.

The top-priority threats listed in the report are anthrax, botulism, filoviruses (Ebola and Marburg), glanders and meliodosis, Junin virus, plague, smallpox, tularemia, typhus, radiological and nuclear threats, and volatile nerve agents. The nation currently has Food and Drug Administration–approved medical countermeasures only for anthrax, plague, smallpox, tularemia, and radiological agents, the report says.

It adds that some unlicensed countermeasures, including antitoxins for anthrax and botulism, are available tin large quantities and could be used under an emergency use authorization (EUA).

To help in preparing the report, the NBSB working group published in the Federal Register last August an inventory of issues helping or hindering industry involvement in countermeasure development and received public comments.

The group also interviewed industry officials, who said they found contracting with the federal government to be "slow, unwieldy, expensive, and opaque," the report states. Things improve once a company actually has a contract, but lack of coordination among federal agencies is a problem, as is the lack of a clear definition of a "usable product."

In looking for historical examples of government-industry collaborations, the panel considered the Manhattan Project—the World War II effort to build the first nuclear bombs—but concluded that it's not the best analogy. Better models, it says, are offered by the Navy's contracting for aircraft carriers and by the space program. The steady acquisition of new aircraft carriers gives the shipbuilding industry confidence, it says.

A major question for industry is whether Congress "will appropriate adequate funding, sustained across a decade or two, for MCM discovery, development, trials, and licensure of the full MCM portfolio," the panel asserts. For example, the Project Bioshield Special Reserve Fund, a $5.6 billion fund authorized in 2004, was intended for procurement of finished products, but in recent years chunks of it have been diverted for advanced research and development.

Given that biological threats are a national security issue, the panel suggests that one way to improve coordination would be to put a White House official in charge: "A White House representative could form and chair an MCM integrated product team and monitor its progress. Team members could include experts from the federal government, industry, academia, and other civilian entities."

This approach might require waiving certain federal acquisition regulations so that national experts could help identify requirements for a product and then respond to requests for proposals that would be released based on their work, the report notes.

An alternative to using a White House–led team is to "designate one federal agency responsible for MCM development based on prioritized civilian and DoD [Department of Defense]–unique requirements and fund that agency adequately," the panel said.

Among the eight specific recommendations, the report says the government must do a better job of preparing for "anticipatable emergencies." One of these is the exposure of children to anthrax spores. Accordingly, the government should undertake clinical trials to determine the appropriate dose of anthrax vaccine, and several other countermeasures should also be tested for pediatric dosing, the group asserts.

The panel also suggests that the government assemble "mockup" collections of data to prepare the way for quick EUAs for unlicensed countermeasures in case of attack.

Among its other recommendations, the report says:

  • Congress and the executive branch must provide adequate, consistent funding.
  • The government must speed up the development and acquisition of countermeasures and "optimize distribution methods."
  • The government should expand MCM markets to include state and local first responders and allied governments.

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