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Wednesday, March 3rd, 2021

Energy and Commerce subcommittee examines U.S. biological threat preparedness

The Energy and Commerce Committee Subcommittee on Health held a hearing entitled “Examining H.R. 3299, Strengthening Public Health Response Act” on Thursday to examine legislation meant to better prepare the U.S. to fight biological threats.

The Strengthening Public Health Emergency Response Act of 2015, H.R. 3299, introduced by U.S. Reps. Susan Brooks (R-IN) and Anna Eshoo (D-CA), was written in response to an October report by the Blue Ribbon Study on Biodefense that warned that the U.S. was not prepared for emerging biological threats.

“The nation has not come to fully appreciate the severity of the biological threat and our leaders have not demonstrated the political will to fully address it,” the Blue Ribbon Study report said. “We must address these shortcomings by prioritizing the following ares: 1) coordination and accountability among federal departments and agencies; 2) collaboration between federal and non-federal stakeholders; and 3) innovation that addresses both lingering and novel problems.”

H.R. 3299 legislation would streamline decision-making procedures while incentivizing investment in vaccines and treatments for dangerous and deadly diseases and pathogens.

“When biological threats are considered, the most important part of our preparedness is the successful development of vaccines and treatments before a biological threat or attack occurs,” Brooks said. “Having treatments and vaccines ready when a biological threat like Ebola strikes has immeasurable benefits, not the least of which is significantly limiting the scope of the outbreak. Given reports that ISIS is pursuing chemical and biological weapons, we must act now to prepare ourselves for the challenges that these kinds of weapons pose to our collective health and security.”

Thirty-three recommendations to improve the U.S. response to biological threats were made by the Blue Ribbon Study on Biodefense, which was led by former U.S. Sen. Joe Lieberman (I-CT) and former Pennsylvania Gov. Tom Ridge, the first Secretary of Homeland Security. The panel’s report was based on meetings, interviews and research.

“Securing our nation against biological threats is a challenging endeavor,” Acting Biomedical Advanced Research and Development Authority (BARDA) Director Dr. Richard Hackett said. “The array of threats for which we must be prepared is vast. Such threats include bioterrorist agents such as anthrax, smallpox and botulism; evolving and emerging threats causing substantial regional disruption such as Ebola and Zika; and highly communicable diseases with pandemic potential such as influenza.”

One impediment to preparing for biological threats, according to U.S. Rep. Joe Pitts (R-PA), is the lack of demand in the private market for medical countermeasures to biological threats.

“The 2006 Pandemic and All Hazardous Preparedness Act was authorized through 2011,” Pitts testified. “It established research and development through BARDA at HHS to coordinate and accelerate the development of medical countermeasures. There is virtually no demand in the private market for these medical countermeasures, so BARDA bridges the funding gap between early-stage funding and the ultimate procurement of products for the national stockpile.

“By partnering with the private sector, BARDA can reduce the risk entailed in medical countermeasure research, thereby helping to mitigate the disincentives associated with countermeasure spending.”

Hackett pointed to the response to the Zika virus as an example of how production can be ramped up in the event of an emergency.

“When it is an emergency, like with Zika, we can act extremely quickly and responsively,” Hatchett said. “Operationally, the PHEMCE (Public Health Emergency Medical Countermeasures Enterprise) establishes product-specific requirements for CBRN medical countermeasures based on Material Threat Assessments developed by DHS. NIH and DoD support discovery and early-stage development of product candidates, often in collaboration with academic and industry partners, and prepare them for the transition to BARDA.

“In turn, BARDA supports and assists product candidates through advanced research and development, including preparation for FDA review, until they are ready for acquisition under Project BioShield. After procurement, medical countermeasures are maintained at CDC’s Strategic National Stockpile (SNS) location or within virtual stockpiles maintained by commercial vendors…If advanced development data lead to FDA approval of a marketing application, the financial responsibility for purchasing medical countermeasures for stockpile and delivery transfers from BARDA under Project BioShield to SNS. Items that have not yet received FDA licensure can also be procured for the stockpile if they are eligible for use during an emergency under an Emergency Use Authorization.”

H.R. 3299 would also expand the Priority Review Voucher program to allow for material threats identified by the Department of Homeland Security.

“Our national readiness and biodefense capabilities are underprepared,” Brooks said. “The threat to our national security posed by dangerous and deadly diseases and pathogens, like Ebola or anthrax, is constant and cannot be under estimated. The legislation we considered today is the result of more than a year of bipartisan work at this committee, and I look forward to further consideration of this proposal to better protect the health and safety of the American people.”