Archives: Biodefense

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Recent Support of Countermeasure Development Poised to Continue in Reauthorization of PAHPA

The U.S. Government has recently taken a number of steps to reinvigorate its support of medical countermeasure development. In particular, by pursuing new methods of contracting, updating regulatory frameworks, and establishing additional incentives for capital investment, the U.S. Government has confirmed that countermeasure development remains a critical component of public health preparedness. Now, over the … Continue Reading

FDA Commitment to MCM Development Reflected in New Draft Guidance on Medical Countermeasure Priority Review Vouchers

On January 19, 2018, FDA announced the availability of a new draft guidance, titled “Material Threat Medical Countermeasure Priority Review Vouchers.” FDA’s publication of the draft guidance, which was issued by FDA’s Office of Counterterrorism and Emerging Threats (OCET) without a statutory mandate – reflects the commitment of FDA leadership to the development and approval … Continue Reading

DARPA Targets Animal-Based Viral Threats in Solicitation for PREEMPT Program

On January 19, the Defense Advanced Research Projects Agency (“DARPA”) issued a new solicitation in the form of a broad agency announcement for the Preventing Emerging Pathogenic Threats—or “PREEMPT”—program. The program will be managed by the DARPA Biological Technologies Office, which generally supports activities that integrate biology, engineering, computer science, physical sciences, and mathematics. The … Continue Reading

DoD Class Deviations Allow for Greater Contracting Flexibility in Times of Crisis

The Department of Defense (“DoD”) has issued two Class Deviations that provide defense agencies with greater flexibility when procuring in times of crisis. These Class Deviations allow for the use of simplified acquisition procedures and excuse certain procurement obligations when DoD is responding to a cyber-attack or providing relief in support of domestic or international … Continue Reading

Senate Committee Directs DoD to Reduce Drug Prices

In its Report on the National Defense Authorization Act for Fiscal Year 2018, the Senate Armed Services Committee (the “Committee”) included an “Item of Special Interest” directing the DoD to exercise its rights under the Bayh-Dole Act “to authorize third parties to use inventions that benefited from DOD funding whenever the price of a drug, … Continue Reading

DARPA Seeks to Establish New Platforms for Rapid Development of Medical Countermeasures

Last week, the Defense Advanced Research Projects Agency (“DARPA”) issued a new broad agency announcement (“BAA”) seeking proposals to support the creation of an integrated “capability platform” for the delivery of medical countermeasures to prevent a pandemic threat within sixty days of targeting a known or newly emerging pathogen.  The BAA confirms DARPA’s commitment to … Continue Reading

Zika Virus Complications Lead to Expected Government Partnership with Private Industry

Concerns about the spread of Zika virus and potential complications associated with infection may soon lead to new research and development opportunities for government contractors and grant recipients.  Similar to developments after the recent Ebola outbreak in West Africa, a need to better understand Zika’s characteristics and develop an effective countermeasure or vaccine has led both domestic and … Continue Reading

President Signs Act Authorizing $5.4 Billion in Emergency Funding to Combat Ebola

Yesterday, President Barack Obama signed into law a $1.1 trillion appropriations act that allocates approximately $5.4 billion in emergency funding to support the U.S. Government’s response to the Ebola outbreak in West Africa.  Although this funding falls short of the Administration’s initial $6.18 billion request—approximately $1.54 billion of which was to be allocated to a … Continue Reading

HHS Issues PREP Act Declaration Covering Ebola Vaccines

The U.S. Department of Health and Human Services (“HHS”) published a declaration today under the Public Readiness and Emergency Preparedness (“PREP”) Act covering activities relating to three Ebola vaccine candidates that are currently in development.  The declaration went into effect on December 3, 2014 and extends liability protection to manufacturers, distributors, program planners, and qualified … Continue Reading

Defense Threat Reduction Agency Seeks “Near-Term” Solutions to Ebola Outbreak

The Defense Threat Reduction Agency (“DTRA”) issued a broad agency announcement (“BAA”) at the end of last week seeking “near-term” solutions that can be developed in time to assist with the current (Zaire) Ebola virus outbreak in West Africa.  Expanding on the BAA under which the U.S. Department of Health and Human Services (“HHS”) is … Continue Reading

Government Looking to Existing Procurement Vehicles to Stem Ebola Threat

As the U.S. government works to address the threat posed by the Ebola virus, one tool available to the Department of Health and Human Services (HHS) in this effort is a broad agency announcement (BAA) originally issued in 2009 as a means of accelerating the development of vaccines, therapeutics, and diagnostics to prevent and treat … Continue Reading
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