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

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