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 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 past two weeks, a two-part congressional hearing has suggested that recent efforts may soon be accompanied by key legislative changes, including much needed funding authorizations and incentives. As a result, the upcoming reauthorization of the Pandemic and All-Hazards Preparedness Act (“PAHPA”), and its prior reauthorization, may present a critical opportunity to continue to improve public-private relationships in countermeasure development.


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

On January 19, 2018, FDA announced the availability of a new draft guidance, titled “Material Threat Medical Countermeasure Priority Review Vouchers.” FDA’s publication of the draft guidance, which was issued by FDA’s Office of Counterterrorism and Emerging Threats (OCET) without a statutory mandate – reflects the commitment of FDA leadership to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 of medical countermeasures (MCMs). In a question and answer format, FDA provides details about the Agency’s interpretation and implementation of the MCM priority review voucher (PRV) program, which was established in December 2016 by the 21st Century Cures Act (Section 565A of the Federal Food Drug, and Cosmetic Act (FD&C Act)). That provision, intended to incentivize the development of MCMs, requires FDA to award a PRV to the sponsor of a successful marketing application that meets certain statutory criteria.

Continue Reading FDA Commitment to MCM Development Reflected in New Draft Guidance on Medical Countermeasure Priority Review Vouchers

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

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