Counter-Bioterrorism Reform Plan Looks Promising, Experts Say

August 20, 2010
By Matt Korade, CQ Staff

The Obama administration has struck out in a bold, new direction by announcing an overhaul of the production of countermeasures to bioterrorism and pandemic disease, observers say, adding that the plan’s more prosaic recommendations might be as important as its eye-catching items.

The administration’s planned new direction, released Thursday, calls for reinvesting $1.9 billion in funding left over from last year’s response to the H1N1 “swine flu” pandemic. While some of that money would go toward attention-getting proposals — such as creating a new strategic investment agency to promote innovative but struggling companies — experts also praised less catchy recommendations, such as managerial changes to the countermeasure development effort and a proposal to give the Food and Drug Administration (FDA) $170 million to revamp the way it approves new drugs and vaccines.

The FDA money would go toward improving its scientific expertise and assessment tools and creating special teams to work on high-priority medical countermeasures. Those teams would work from across the FDA to identify problems and resolve them early in the regulatory process. The review also recommended that the Department of Health and Human Services (HHS) create “early development teams” to provide guidance to its public health agencies, academic researchers and biotech companies working on promising drug candidates.

Retired Air Force Col. Randall Larsen, who served as executive director of the congressionally chartered Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism, said the review shows the administration understands that the security challenges of the 21st century require new solutions, including bringing the FDA into the national security fold.

Larsen said he only rarely describes new government programs as imaginative and well-conceived — but that the new strategy would deserve that description if properly executed.

“It will help transform the ability of the government to develop and manufacture the medicines and vaccines needed to protect the nation’s health,” Larsen said, adding that the senior public health officials responsible for the review should be commended for their work.

Changes in Management
The administration’s review calls for changing the leadership structure of the medical countermeasure enterprise, recommending that HHS designate one person as coordinator of its overall efforts and establish a decision-making senior leadership council to provide strategic oversight of the effort.

In addition, the administration recommends HHS’s Office of the Assistant Secretary for Preparedness and Response and its Biomedical Advanced Development and Research Authority (BARDA) speed up their contracting process and improve communication with industry. The agencies, which work with biotechnology firms during the later stages of drug development, need to ensure that the business community receives information on the size of the market for certain countermeasures and the price the government will pay for them, the review said.

Furthermore, HHS and other partners should develop a comprehensive, five-year budgeting process for the effort, covering everything from the initial stages of development to the maintenance of the Strategic National Stockpile, the report said.

“All these things are really good,” said Francesca Cook, senior vice president of policy and government affairs for the Annapolis, Md., pharmaceutical company PharmAthene, Inc., which is under contract to develop anthrax vaccine for the U.S. government.

The review’s proposed guarantee of timely information, improved guidance and removal of regulatory obstacles would be critical to generating and sustaining private sector interest, she said. Having the FDA and BARDA collaborate and clear the pathway for the development and approval of drugs and vaccines would be especially critical, she said.

“We’re very supportive of the initiatives in the regulatory science arena,” Cook said.

However, she added that the overhaul faces a tough path to success.

Anders Hedegaard, president and CEO of the Danish biotechnology company Bavarian Nordic, said the administration’s recommendations would simplify his company’s efforts to overcome the unique challenges of medical countermeasures development. Bavarian Nordic recently delivered 1 million doses of a next-generation smallpox vaccine to the U.S. stockpile, a milestone that was only reached through an intensive, seven-year partnership with HHS, he said.

“The development of an integrated, five-year budget for medical countermeasures development, procurement and stockpiling, and a clear articulation of the U.S. government’s requirements, will allow us to better target our investments in product development,” he said.

Funding Security
Despite the proposed use of unspent money from the H1N1 response, industry observers worry that the administration and lawmakers will not sustain their commitment to established biodefense investments.

Those investments include the Project Bioshield special reserve fund, which HHS uses to purchase pharmaceuticals for use in national emergencies. On Friday, President Obama tweaked his pending request for fiscal 2011 funding of health programs, including a provision that would let HHS transfer as much as $200 million in existing funds from Bioshield to the Pentagon to establish a technical center to aid in developing countermeasures against chemical, biological, radiological, and nuclear threats and emerging infectious diseases.

Friday’s request, made to House Speaker Nancy Pelosi, D-Calif., also would transfer up to $200 million from Bioshield for the new strategic investment corporation, which is intended to support companies working on new infection-fighting drugs, diagnostic tests and medical countermeasures.

Pharmaceutical companies have said proposals to use Bioshield money for other priorities erodes private-sector confidence that government money will be available to companies to pay for their costly and often financially risky development of new drugs and vaccines.

Barry Kellman, president of the International Security and Biopolicy Institute, a nonprofit dedicated to global biosecurity policy, said the proposed regulatory changes could provide a way around the funding concerns.

If U.S. agencies harmonize regulations with allied governments, it could expand the number of companies willing to get involved in the medical countermeasures program, Kellman said. In this way, the relatively small investment in a new regulatory framework could stretch U.S. dollars over the long run, he said.

“The real answer here is to substantially expand the market, and that’s a regulatory, not a financial challenge,” Kellman said.

The administration’s strategic push could provide a new opportunity for cooperation at both ends of Pennsylvania Avenue, experts said.

“I am neither a medical practitioner nor a public health specialist,” Larsen said. “But I do understand that the FDA is now as important to national security as the National Security Agency, the FBI or the U.S. Air Force. I hope Congress understands that.”

Matt Korade can be reached at mkorade@cq.com