Following up on our post earlier this week giving a general overview of the Defense Production Act of 1950 (“DPA”), 50 U.S.C. §§4501 et seq., this post comments on President Trump’s March 18, 2020 Executive Order on Prioritizing and Allocating Health and Medical Resources to Respond to the Spread of COVID-19 (the “COVID-19 E.O.”) and provides some key considerations that companies should keep in mind if they are concerned about receiving prioritized or rated contracts or allocation orders or directives under the DPA.
Continue Reading The Defense Production Act and the Coronavirus Executive Order: Key Considerations

As a followup to our recent post on the implications of the PREP Act for government contractors working to respond to the COVID-19 outbreak, this post will provide an overview of the Defense Production Act—including its key powers that the federal Government might invoke to counter the pandemic.
Continue Reading A Coronavirus Contractor’s Guide to the Defense Production Act

We’ve covered several topics already this week on the U.S. Government’s varied responses to the COVID-19 outbreak and how these responses will affect contractors that do business with the government, including BARDA’s EZ-BAA for COVID-19 diagnostics, mission-essential services during the outbreak, and how excusable delay provisions may help federal contractors affected by the outbreak.  But one area that has yet to receive in-depth discussion is the federal government’s mechanisms for addressing liability concerns raised by the use and distribution of countermeasures to the virus.  After all, while contractors are no doubt responding with appropriate speed and diligence in developing and deploying various COVID-19 countermeasures, no contractor wants to be the subject of a product liability, warranty, or negligence lawsuit later down the road.

Thankfully, Congress anticipated this concern and addressed it in 2005 by passing the Public Readiness and Emergency Preparedness Act (“PREP Act”), codified at 42 U.S.C. § 247d-6d.  Since enactment, the PREP Act has been used to issue declarations covering various countermeasures, including therapeutics, diagnostics, devices, vaccines, and constituent materials for pandemic influenza, acute radiation syndrome, smallpox, Botulism, anthrax, Zika, nerve agents, certain insecticides, and Ebola.  And earlier this week, the Secretary of the U.S. Department of Health and Human Services (the “Secretary”) issued a declaration pursuant to the PREP Act specifically for COVID-19 countermeasures.

This post will cover the PREP Act generally before discussing the implications of the COVID-19 declaration.
Continue Reading A Coronavirus Contractor’s Guide to the PREP Act

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

As of February 10, 2020, the World Health Organization (WHO) reported that 40,554 cases of the Novel Coronavirus (2019-nCoV) have been confirmed globally, with twelve cases confirmed in the United States.  The WHO has been issuing situation reports on a daily basis since January 21, and each report in February alone has identified more than 2,000 to 3,000 new cases each day.

Due to the lack of approved therapeutics, vaccines, and diagnostics for this threat, developing new products and testing products already approved for other uses is a high priority for the U.S. interagency response effort—the Medical Countermeasure (MCM) Task Force.  The Biomedical Advanced Research and Development Authority (BARDA), under the Office of the Assistant Secretary for Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS), is leading this Task Force in partnership with U.S. Department of Defense, Food and Drug Administration, Centers for Disease Control and Prevention, and National Institutes of Health.

BARDA is currently looking at the effectiveness of existing countermeasures for similar viruses, as well as potential new responsive technologies, including vaccines, diagnostics, therapeutics, and medical supplies.  BARDA is serving as the sole point of entry for product and technology submissions to ensure there is an expedited process for receipt and review of proposed solutions for 2019-nCoV.  In this capacity, BARDA has released two opportunities to submit potential solutions for the 2019-nCoV response discussed below: (1) the EZ-BAA for 2019-nCoV diagnostics and (2) market research packages for any and all potential products and supplies.  Covington encourages those with technology that could be potentially useful to respond.


Continue Reading U.S. Government Seeks Industry Solutions in Novel Coronavirus Response

Last year, we highlighted the Court of Federal Claims’ (“COFC”) decision in Starry Associates, Inc. v. United States, 127 Fed. Cl. 539 (2016), which sharply criticized a Department of Health and Human Services (“HHS”) decision to cancel a solicitation, a rare rebuke in an area where agencies enjoy considerable deference from the courts. The Court’s decision noted the unique circumstances of that case—a series of agency actions resulting in the cancelation of the solicitation at issue that the Court characterized as “capricious” and “reflect[ing] a lack of fidelity to the procurement process.” That cancelation resulted in multiple GAO protests, a hearing at GAO, multiple depositions of agency officials during a follow-on protest at the Court, and a decision enjoining HHS from cancelling the solicitation (raising the interesting question of whether HHS must now award the contract to Starry Associates). In a subsequent decision issued in the case last week, Starry Associates, Inc. v. United States, No. 16-44C (Fed. Cl. Mar. 31, 2017), the case’s exceptional nature was further demonstrated by the COFC’s decision to award “enhanced” attorney fees to plaintiff’s counsel.
Continue Reading COFC Awards Enhanced Attorney Fees In Protest Following “Egregious” Agency Conduct

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 international public bodies and private industry to begin mobilizing resources in response to the virus.  As a result, both new and existing contractual vehicles will likely be used to fund a wide array of activities, extending from epidemiological studies to the development of new diagnostics and countermeasures.

Similar to yellow fever, dengue, West Nile, and Japanese encephalitis viruses, Zika is a flavivirus that is generally transmitted through mosquitoes.  Although Zika was first discovered in 1947, it has only recently been identified as a significant threat to public health based on a potential connection between Zika and microcephaly in newborns—a condition associated with incomplete brain development.  Recent events have also provided additional evidence of a potential link between Zika and Guillain-Barré syndrome, which is a nervous system disorder that could affect Zika’s carriers.

Previously, the virus was understood to have relatively limited consequences, only causing mild, flu-like symptoms in one of five of its hosts.  However, an outbreak of the virus in French Polynesia in 2013 and 2014 has now been associated with an increase in cases of Guillain-Barré syndrome.  In addition, an ongoing outbreak of the virus that began in Brazil last year has affected over one million individuals and been linked to both an increased incidence of Guillain-Barré syndrome and a dramatic rise in cases of microcephaly.  Zika RNA has been discovered in the amniotic fluid of women with affected fetuses in Brazil, and a recent report indicates that an affected newborn in Hawaii acquired Zika in the womb.


Continue Reading Zika Virus Complications Lead to Expected Government Partnership with Private Industry

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 contingency fund similar to appropriations made in response to pandemic influenza—all emergency funding for Ebola provided by the act is available for immediate use.  The funding is split between the Department of Health and Human Services (“HHS”), the Department of Defense (“DoD”), the Department of State, and the Agency for International Development (“AID”).  Government contractors and grant recipients can expect these agencies to use their respective shares of the funding to create a number of opportunities in the coming months.

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

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 persons who prescribe, administer, or dispense the vaccine candidates identified in the declaration when distributed in connection with a federal contract, grant, or other agreement, or as directed in a public health emergency.  The declaration represents another significant step in the federal government’s response to the Ebola outbreak in West Africa, following recent actions taken by HHS and the Defense Threat Reduction Agency to fund the development of Ebola countermeasures and related products and services.
Continue Reading HHS Issues PREP Act Declaration Covering Ebola Vaccines

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 the disease. On October 16, for instance, the agency highlighted that BAA in announcing the award of an $8.6 million contract for the development of an experimental Ebola vaccine. That announcement came on the heels of another HHS award in September 2014 — this one worth $42.3 million — for the development of a separate drug to treat Ebola infections, ZMapp. Additionally, HHS recently issued a task order under its Centers for Innovation in Advanced Development and Manufacturing (CIADM) program inviting three qualified laboratories to submit proposals for the acceleration of production of experimental ZMapp doses. HHS officials have signaled a readiness to look to the BAA in order to identify other qualified technologies for additional awards to combat Ebola.

In a recent press release announcing that HHS is “seeking additional proposals” for the advanced development of Ebola treatments, Robin Robinson, the Director of HHS’s Biomedical Advanced Research and Development Authority (BARDA), vowed that the agency would “push[] hard to advance the development of multiple products as quickly as possible for clinical evaluation and future use in preventing or treating this deadly disease.” For companies with an interest in assisting the government in its Ebola prevention and treatment efforts, a strong working understanding of the above-referenced BAA and its requirements is vital.


Continue Reading Government Looking to Existing Procurement Vehicles to Stem Ebola Threat