Expert testifies before committee on CBRN countermeasures

Cynthia Bascetta, the managing director of healthcare issues at the Government Accountability Office, explained the challenges in developing CBRN countermeasures to the House Subcommittee on Emergency Preparedness, Response and Communications this week.

"The anthrax attacks of 2001 raised concerns that the United States is vulnerable to intentional threats from CBRN agents," Bascetta said. “The federal government faces a variety of challenges in developing and acquiring medical countermeasures, such as the high failure rate in research and development and difficulties meeting regulatory requirements.

"Members of Congress, federal commissions, and other experts have noted the need for the United States to acquire available medical countermeasures and develop new ones to protect the public from attacks with CBRN agents. While rapid diagnosis, treatment, and prevention may minimize the public health impact of a release of these agents, there are currently few countermeasures available for many CBRN agents, and research and development to create usable countermeasures is a lengthy and complex process."

Bascetta said at the hearing, which focused on developing and acquiring medical countermeasures against chemical, biological, radiological and nuclear agents, that “the failure rate for development and licensure of most drugs, vaccines and diagnostic devices can be more than 80 percent, depending on the stage of scientific research and development. Given this risk, as well as a lack of a commercial market for most medical countermeasures, attracting large, experienced pharmaceutical firms to research and develop them is challenging.”

Bascetta also said that there are several challenges to regulatory processes to evaluate promising countermeasures.

"These challenges include proving a countermeasure’s effectiveness using animals as proxies for humans because humans cannot ethically be used in studies involving CBRN agents, determining appropriate doses of countermeasures for children who may be more vulnerable to exposure to CBRN agents and evaluating the safety and effectiveness of medical countermeasures for use in a public health emergency if they have not yet been approved or licensed," Bascetta said. "Finally, HHS faces the logistical challenge of ongoing replenishment of expiring medical countermeasures in the US.”

Because most CBRN countermeasures have not yet been developed, Bascetta said, the Department of Health and Human Services supports and oversees several stages of research and development of countermeasures. Priority CBRN countermeasures are coordinated by HHS through an interagency body that includes other federal agencies with similar responsibilities, including the Departments of Homeland Security and Defense.

Bascetta said that smaller biotechnology companies are more likely to develop medical countermeasures but that the HHS needs to provide these companies with more guidance, as smaller companies are likely less experienced that larger companies.