The world has been almost singularly focused on the 2019 coronavirus for more than 18 months now, but the fact remains that we still face an array of other known pathogens with pandemic potential and any number of unknown pathogens that could pose a similar risk.  These threats have periodically been an area of congressional focus since the 2009 H1N1 influenza pandemic, and most recently a bill for the Disease X Act would renew this focus and direct it at new, currently unknown viral threats.  The bill is poised to be a key piece of legislation in ongoing and future biodefense initiatives and pandemic preparedness. Continue Reading The Next Pandemic: New Bill Looks Ahead to Counteract Novel Threats

In the latest World Health Organization daily situation report, as of March 11, 2020, the WHO reported 118,326 COVID-19 cases confirmed and 4,292 deaths worldwide, and the U.S. Centers for Disease Control and Prevention (CDC) reported 938 cases and 29 deaths in the United States.  The same day, WHO characterized COVID-19 as the first global pandemic sparked by a coronavirus.  Additionally, the Secretary of the U.S. Department of Health and Human Services (HHS), issued a Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) to provide liability immunity for entities against any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of covered medical countermeasures (MCMs).  Prioritized pathways are now available to expedite review of new, responsive technology proposals for MCMs from diagnostics to therapeutics.

Continue Reading Expanding the Coronavirus Disease 2019 (COVID-19) Response through Diagnostic Development

Last week, the FAR Council issued a Final Rule, setting forth new FAR provisions that require the reporting of certain counterfeit and suspect counterfeit parts and certain major or critical nonconformances to the Government – Industry Data Exchange Program (“GIDEP”).[1]  This Final Rule comes more than five years after the rule was first proposed in the Federal Register in June 2014.  The FAR Council describes the Final Rule as “significantly de-scoped” from the version proposed in 2014, but it nonetheless constitutes a significant expansion of the existing counterfeit part reporting obligations, which to date have applied only to electronic parts under DOD contracts.

Continue Reading New FAR Rule Expands Counterfeit Reporting Obligations

Late last month, the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (PAHPAI) was signed into law.[1] The Act is a much anticipated reauthorization of the Pandemic and All-Hazards Preparedness Act, originally passed in 2006.[2] The legislation is a key development in strengthening the country’s ability to respond to bio-threats, disasters, and other national emergencies by defining federal program initiatives and funding states and private researchers. PAHPAI-authorized grants allow for the research and development of biodefense measures and the stockpiling of preparedness supplies.

Continue Reading PAHPAI Reauthorizes Key Biodefense Initiatives and Provides Opportunities for Industry Partners

The Section 809 Panel recently concluded its monumental analysis of defense acquisition law and regulations and released its third volume of recommended changes.  As we have written previously, the Panel’s work stands out from previous acquisition reform efforts with the appendices of detailed legislative and regulatory changes that accompany the commissioners’ analysis and recommendations.

Given the scope of the Panel’s work, few believe that Congress or the Department of Defense (“DoD”) will — or even could — simply adopt the recommendations in full.  Legislative bandwidth for additional acquisition reform is finite, and some of the Panel’s recommendations will prompt robust debate.  In this post, we analyze some of the recommendations that government contractors should follow most closely.  We highlight key issues and address the political dynamics involved in enacting them. Continue Reading After the Final Report: Expectations Following the Section 809 Panel’s Third Volume of Acquisition Policy Reforms

Registration will open soon for the Biomedical Advanced Research and Development Authority’s (“BARDA”) 2018 Industry Day to be held on October 29 and 30 at the Grand Hyatt in Washington, D.C. This event has been an integral part of BARDA’s outreach efforts to the life sciences community since 2007, and the newest version of this event promises to continue to provide meaningful insight into BARDA’s role in the nation’s public health preparedness efforts.

BARDA is expected to revisit annual topics like revisions to its broad agency announcement and updates to its goals and Government-wide strategic plans. In addition, this year BARDA will have a particular focus on innovation with the rollout of its Division of Research, Innovation, and Ventures (“DRIVe”) and lightning talks on noteworthy development efforts. Applications to participate in lightning talks are due soon, and potential participants should consider whether to take advantage of this unique opportunity.

Continue Reading Save the Date – BARDA Industry Day Is Coming

As the Senate approaches the end of its debate on the National Defense Authorization Act for Fiscal Year 2019, provisions of the bill regarding access to and review of information technology code deserve close attention.  These sections, if enacted, would significantly impact Department of Defense contractors and also would affect matters associated with investments subject to review by U.S. national security agencies.

As drafted, the provisions could expose current and prospective contractors to intrusive scrutiny and significant risks.  They lack clarity on key definitions, leaving the precise scope of those risks unclear.  We summarize major issues and concerns below.  We expect these provisions to receive scrutiny during the House-Senate conference on the NDAA over the summer.  Continue Reading Senate Armed Services Committee Proposes Expansive but Unclear Software Review Provisions

Earlier this week, both chambers on Capitol Hill took steps that would increase the Department of Homeland Security’s (DHS) role in the area of cybersecurity.  On the Senate side, the Senate Homeland Security and Governmental Affairs Committee approved a DHS reauthorization bill that included amendments to rename and reorganize the DHS National Protection and Programs Directorate (NPPD), to increase protections for certain personally identifiable information (PII), and to emphasize the need for cybersecurity research.  On the House side, the House Homeland Security Committee approved the Cyber Incident Response Teams Act, which would establish teams within DHS devoted to cyber incident response.

Continue Reading DHS Cybersecurity Legislation Advances Through Capitol Hill

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 goal of the program is to support research and development relating to new tools, models, and technologies that are focused on preventing the transition of viral threats from animals to humans. In contrast to recent biodefense efforts that have largely been initiated in response to significant human outbreaks, such as in connection with Ebola, influenza, and Zika, the program targets animal-based viruses that have yet to become an active threat to humans. In addition, consistent with DARPA’s mission, the program targets animal-based viruses that have a potential to impact deployed U.S. military forces, particularly with respect to remote geographic areas associated with prevalent endemic and emerging diseases.

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

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 addressing national security concerns raised by both naturally occurring public health emergencies and bioterrorism, as well other biological threats to members of the U.S. military.  Learning from recent experiences with Ebola, Zika, and Middle East respiratory syndrome, DARPA is targeting prophylactic solutions that are designed to prevent or halt the spread of an infectious outbreak, rather than solutions intended solely or primarily to treat infected individuals.

DARPA’s approach is consistent with recent guidance from the President’s Council of Advisors on Science and Technology in that it focuses on platform technologies and processes, which represent general approaches to medical countermeasure development that can be rapidly and reliably applied to varying threats.  The Biomedical Advanced Research and Development Authority has adopted a similar focus in its own platform-based BAA, and additional opportunities for platform development will likely arise in the near future under the most recent strategy and implementation plan of the Public Health Emergency Medical Countermeasures Enterprise.

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