Congressional Quarterly Homeland Security

(Reprinted with the Permission of CQ)
Dec. 2, 2009

Bioterror Experts, Industry Encouraged by Federal Review of Countermeasure Development
By Matt Korade, CQ Staff

and distributing new medicines for public health threats, a move that could portend an increase in investment, public health officials say.

The goal of the federal review is to modernize medical countermeasures to all public health threats — including bioterrorism — creating a system “so dependable and comprehensive that it deters potential bioterrorism attacks and makes our enemies say, ‘It’s not worth the effort,’ ” said Health and Human Services Secretary Kathleen Sebelius during the American Medical Association’s Third National Congress on Health System Readiness, held Nov. 30.

Among the groups calling for improvements to the government’s biosecurity efforts is the congressionally established National Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism. Its December 2008 report, “World at Risk,”, estimated a greater than 50 percent probability of a terrorist WMD attack somewhere in the world by 2013 and said the weapon would most likely be biological in nature.

In its second report, “The Clock Is Ticking,” the commussion focused on a “range of missteps” by the executive branch and Congress in recent months that have hindered U.S. biosecurity efforts. But the Obama administration’s announcement of a comprehensive review indicates that the situation could be changing, Randy Larsen, the commission’s executive director, said Wednesday.

“We’re stuck with a system right now that’s been inherited through generations,” Larsen said. “And what the commission is trying to say is ‘We’re not here to point fingers, We’re just saying it’s time to take action.’ So we applaud her speech, and what I was most impressed with is that she said the review would be out in early 2010.”

Since the advent of the H1N1 pandemic, a top talking point for the commission has been that America needs the capability to produce vaccines and therapeutics faster and less expensively, Larsen said.

“We see that is a national security issue, not just a public health issue,” he said.

Gretchen Michael, a spokeswoman for the HHS’s assistant secretary for preparedness and response, said the announcement of the review could mean more money for the development and acquisition of countermeasures.

“Let’s look at the entire spectrum of things,” Michael said Wednesday, explaining the administration’s rationale. “Here are the threats. How can we strategically look at this and set up systems so that, not only from the [Biomedical Advanced Research and Development Agency] side, but also from the early stage of development at [the National Institutes of Health . . . we align all of the money spent so that we are spending money well and investing consistently along the way so that we can arrive at where we need to arrive?”

BARDA provides money to companies to bring countermeasures already past the basic development stage into clinical trials and ultimately approval by the Food and Drug Administration. From there, the government uses an acquisitions program called Project Bioshield (PL 108-276) to buy FDA-approved countermeasures from major pharmaceutical companies.

The fiscal 2004 Homeland Security spending bill (PL 108-90) included $5.6 billion in advance appropriations for the fund, allowing up to $2.5 billion to be used in fiscal 2005-08. The remaining money will be available through 2013.

The review will look at that money, Michael said.

“That’s part of the process,” she said. “The Bioshield funding for acquisition is certainly a part of what we’re talking about.”

In her announcement, Sebelius described a comprehensive, continual and long-term overhaul of the medical countermeasures development and procurement process. The changes will seek to improve to basic research and advanced development, manufacturing, stockpiling, and distribution of the countermeasures, she said.

Typically, medical countermeasures take more than a decade to develop, but in an age of growing public health threats — including the threat of bioterrorism — the United States doesn’t have years to wait, she said.

During the response to the H1N1 flu, for example, it became clear that vaccine technology has not kept pace with the need for a rapid response to growing public health threats, Sebelius said. Despite quick action to identify the H1N1 and send a workable vaccine strain to manufacturers, inspect and license vaccine plants and sign production agreements, production speed was ultimately limited by the method of manufacturing, she said. Today’s vaccine production in the United States relies on chicken eggs as the medium for growing virus particles in order to produce the vaccine, a slow process that dates to the 1950s.

To avoid these problems in the future, officials concluded there needs to be a long-term investment in fast, reliable countermeasures development, Sebelius said.

With HHS support, for example, the drug manufacturer Novartis opened the first vaccine plant in the United States to use cell-based, rather than egg-based, production. Cell-based production is a quicker method that removes the danger of egg-based allergies.

HHS also supports a company in Connecticut that is developing a new approach to vaccine production. Instead of trying to grow the whole virus, Sebelius said, they are growing only the part that triggers the immune response.

But the overhaul won’t stop at the development of new technology, she said. A more robust public health response will require changes to the financial, legal and regulatory frameworks that create incentives for large pharmaceutical companies to manufacture countermeasures on a significant scale.

“As a pharmaceutical company, you can usually count on the [Centers for Disease Control] to buy some of a countermeasure to replenish its stockpile,” Sebelius said. “But in many cases, that’s an insufficient market.”

Anders Hedegaard, president and chief executive officer of Bavarian Nordic, a Denmark-based company under contract with Health and Human Services to produce smallpox vaccines, said the news was encouraging.

“As a company with extensive experience working with the U.S. government, we know that long-term funding and commitment to these important biodefense initiatives are crucial,” he said.

Matt Korade can be reached at