Public Policy Briefing
A BioNJ Members-Only Newsletter
May 2018
Is America Prepared to Fight Infectious Diseases and Bio Threats?

After 9/11 and the 2001 anthrax attacks, Congress mandated a dedicated effort to develop and stockpile drugs and vaccines needed to protect Americans from chemical, biological, radiological, nuclear and pandemic threats. Several major legislative initiatives resulted from that mandate, including the Project BioShield Act in 2004, which created a Special Reserve Fund to help fund the development of these products, and the 2006 Pandemic and All-Hazards Preparedness Act (PAHPA), which established the Biomedical Advanced Research and Development Authority (BARDA). Since its inception, BARDA has supported advanced research and development of more than 190 potential medical countermeasures for various threats.

These programs are reauthorized and funded every five years through the PAHPA legislation. With the last reauthorization in 2013, the legislation is due for reauthorization this year. Recent outbreaks, such as Ebola and Zika, have revived a nationwide debate over U.S. preparedness for emerging infectious diseases and emphasized the need for robust public-private partnerships to develop medical countermeasures.

PAHPA reauthorization includes several projects:
  • The Project Bioshield Act of 2004 -- created to accelerate the research, development, purchase and availability of effective medical countermeasures against CBRN agents. It supports the nation's biodefense through three approaches: (1) to secure funding of critical medical counter measures (MCMs); (2) to facilitate research and development through the National Institutes of Health for MCMs; (3) to facilitate the use of MCMs in an emergency through the Emergency Use Authorization following the declaration of emergency by the Secretary of HHS
  • The Special Reserve Fund (SRF) -- authorized $5.6 billion to incentivize biopharmaceutical companies to develop and produce civilian MCMs with little or no commercial market
  • The Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) --overseen by BARDA
  • Ecosystem of financial incentives for developers of MCMs to help them overcome market challenges
BioNJ Co-Hosts Congressional Briefing on PAHPA Reauthorization

On Monday, May 14, BioNJ joined 15 life sciences associations from across the country to co-host a Congressional staff briefing on PAHPA reauthorization. Rep. Susan Brooks (R-IN) and Rep. Anna G. Eshoo (D-CA), Co-Chairs of the Congressional Biodefense Caucus, hosted the briefing, which was held in Rayburn House Office Building.

Panelists who presented at the briefing included:
  • Rick Bright, Ph.D., Deputy Assistant Secretary for Preparedness and Response and Director of the Biomedical Advanced Research and Development Authority (BARDA), Department of Health and Human Services (HHS)
  • Rajeev Venkayya, M.D., President, Global Vaccine Business Unit, Takeda Pharmaceuticals
  • Clem Lewin, Ph.D., MBA, Associate Vice President, Research & Development Strategy, Sanofi
  • Chris Frech, Senior Vice President, Government Affairs, Emergent Biosolutions and Co-Chair of the Alliance for Biosecurity.
The panel was moderated by Kelly Childress Lange, JD, East End Group.
Public Private Partnerships Create Success

The panelists all agreed that the ability to sanction public private partnerships is key to BARDA's success. The PAHPA legislation creates an ecosystem of financial incentives for developers of MCMs to help them overcome market challenges. As of August 2017, BARDA had supported the research and development of 34 products that have been approved and/or cleared by the FDA for use against bio-threats and pandemic influenza. Fourteen of those products have been stockpiled in the Strategic National Stockpile (SNS) for use in the event of a declared emergency. BARDA has partnered with more than 190 academic and company partners and currently has a development pipeline of more than 200 candidate MCMs.
BioNJ Urges New Jersey Congressional Delegation to Commit to 
National Health Security

BioNJ urges the New Jersey Congressional Delegation to continue to prioritize and demonstrate their commitment to national health security by:
  • Providing the resources needed to allow the nation to fully prepare for and defend against biological threats
  • Authorizing and robustly funding pandemic influenza and EID activities
  • Funding BARDA advanced research and development and the Special Reserve Fund in a sustainable way consistent with the levels in the Public Health Emergency Medical Countermeasures Enterprise FY16-20 Multiyear Budget
BioNJ will continue to meet and communicate regularly with our elected and appointed government officials both in New Jersey and in Washington. If you would like to schedule a facility tour or meet with your Congressional representative or your New Jersey legislators, we at BioNJ are happy to work with you to facilitate. BioNJ Member participation is the key to our successful public policy program. Thank you for your support!
Thank You to Our Public Policy Sponsors


We Work for Health of New Jersey
If you would like information on how your organization can support our public policy efforts or how to develop an employee advocacy program, please contact Rebecca Perkins, BioNJ Vice President, Government Affairs, at  [email protected]. For more information on BioNJ, visit www.BioNJ.org.