Medical Device Daily Washington Editor

WASHINGTON – To borrow a line from Elvis Presley, industry seems to be looking for “a little less conversation and a little more action, please,” when it comes to Project BioShield.

During a two-part hearing on Capitol Hill before the House’s Committee on Homeland Security on Tuesday, a panel of government witnesses, followed by a group of six industry representatives, tackled the topic, “Linking Bioterrorism Threats and Countermeasure Procurement to Enhance Terrorism Preparedness.”

The industry representatives told members of the Subcommittee on Emergency Preparedness, Science and Technology that they needed more information about possible terror threats from government agencies, such as the Department of Homeland Security (DHS) and the Department of Health and Human Services (HHS), to balance out the risks, high costs and low returns of investment in bioterrorism countermeasure development.

Despite federal incentives, biotech and drug companies so far have resisted. Along with cost, companies also have expressed concern about liability issues.

BioShield II was proposed in Congress last year to update the legislation and respond to some of industry’s incentive, patent and liability concerns.

James Joyce, founder and CEO of Aethlon Medical (San Diego), was one of the industry panelists on Tuesday and the only one representing the medical device sector.

He told the panel that though the new BioShield legislation expands the definition of counterterrorism to include the general term “therapeutics,” therapeutic devices are not mentioned specifically.

For the most part – at least by National Institutes of Health (Bethesda, Maryland) standards – therapeutics traditionally include only drugs or vaccines, Joyce added, but needs to be broadened.

Aethlon Medical is developing technology it calls the Hemopurifier, a filtration device intended to deliver an immune response process for clearing pathogens and related toxins from the body’s circulation.

Hemofiltration is used as a common therapeutic intervention for the treatment of sepsis and sepsis shock, often the primary cause of death in viral infection, including conditions related to biological weapons, Joyce noted.

He said his company’s device could be used as a first line of defense against drug- and vaccine-resistant bioweapons.

Following the panel’s proceedings in the afternoon, Joyce told Medical Device Daily that the role of devices in the new legislation must be “expanded and clarified.”

“Until it is clarified, a device company really can’t expect to play a role,” he said.

One of the goals of the hearing, and for future deliberations, should be whether the government agencies involved in BioShield conduct “adequate consideration of medical devices,” Peter King (R-New York), chairman of the subcommittee, said in his opening remarks.

Joyce also expressed concern with language in BioShield dealing with commercial markets for countermeasures being considered by the secretary of HHS prior to purchase for stockpiling.

“I believe such open-ended language may deter organizations from pursuing the development of innovative therapies against biowarfare agents,” he said in his testimony. “This language also is counterintuitive [since] the best hope for treating such a wide range of threats is through the evolvement of post-exposure immunotherapeutic countermeasures.”

He argues that therapies such as the Hemopurifier could have boarder market opportunities beyond bioweapons. Aethlon currently is preparing to initiate human trials for HIV and hepatitis C.

“If the goal is to attract the development of treatment countermeasures, then references that imply the presence of a broader market as being detrimental should be eliminated,” he added.

One concern shared by all industry panelists was the process of Material Threat Assessment (MTA) conducted by DHS and HHS. MTA examines biological, chemical, radiological and nuclear agents of greatest concern in an effort to guide BioShield requirements and acquisitions.

BioShield funds can only be used for countermeasures identified by a MTA.

Over the past year only four MTAs have been released – anthrax, smallpox, botulinum toxin, and radiological/nuclear devices – leaving industry and lawmakers wondering where the gaps in the system are and whether or not government agencies are communicating.

“This is an absolute disgrace,” said Rep. Bill Pascrell (D-New Jersey), ranking member on the subcommittee. “Departments don’t talk to each other and are not working effectively. This is absolutely unacceptable, given the task they’re charged with.”

Some lawmakers questioned whether the lines among the different agencies involved in Project BioShield are too blurred and if a better-defined chain of command is needed, perhaps even the appointment of an official to oversee all BioShield-related activities.

“I would hate to see more bureaucracy added to this process, but something needs to be done to better coordinate the process,” said Michael Greenberger, a law school professor and director of the University of Maryland Center for Health and Homeland Security (Baltimore), testifying before the committee.

“The BioShield Act established no procedure for DHS to employ in supervising the making of the material threat determinations,” Greenberger said in his opening statement. “Despite what was an obvious congressional invitation to summarily determine what the widely recognized CBRN [chemical, biological, radiological, or nuclear] threats to the United States, DHS has employed an opaque, highly bureaucratized, relatively lengthy process for determining material threats.”

Greenberger went on to describe the process at DHS and HHS as “cumbersome and poorly delineated.”

DHS had promised more threat determinations by the end of the fiscal year in October, including plague, tularemia, and viral hemorrhagic fevers such as Ebola or Marburg virus.

Representatives from DHS and HHS told subcommittee members that they regularly collaborate with other agencies, including the Center for Disease Control and Prevention (Atlanta), and intelligence agencies and law enforcement bureaus.

Stewart Simonson, assistant secretary in the Office of Public Health Emergency Preparedness at HHS, cautioned subcommittee members and industry that research and development of countermeasures was a “complex, lengthy and expensive” process.

Project BioShield is a $5.6 billion body of legislation signed by President George Bush a year ago to encourage biotech and pharmaceutical companies to develop treatments and vaccines against potential chemical and biological weapons such as anthrax and smallpox.

BioShield also allows the government to buy drugs still under development if they are needed to combat a bioterrorism attack.

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