Foley Hoag lawyers and specialists provide leading innovative life science clients with strategic government affairs and business counseling on Federal acquisitions and procurements, and regulatory and legislative strategy, in the field of biodefense and pandemic preparedness. The core strength of Foley Hoag’s Biodefense and Pandemic Preparedness practice is the expertise of our lawyers and specialists, most of whom have extensive government experience. Our team has served in senior-level positions on Capitol Hill, regulatory agencies, and at industry trade associations.

Notable members of our practice played key roles in the development and enactment of every major bioterrorism and biosecurity preparedness law enacted in the past ten years, leading to enormous opportunities for early-stage life sciences companies. Project BioShield, which became law on July 21, 2004, set aside $5.6 billion to accelerate the research, development, purchase and availability of priority medical countermeasures to protect the US population from the effects of chemical, biological, radiological, and nuclear (CBRN) threats. The creation of the Biomedical Advanced Research and Development Authority (BARDA) in December 2006 revitalized the federal government’s efforts to support and fund the development of medical countermeasures critical to protecting the nation against bioterrorism and pandemic health threats. BARDA injected more than $1 billion into the research, development and procurement of vaccines, antiviral and diagnostics. It also enabled vital new forms of coordination between the government and life sciences innovators.

These federal programs are extremely complex and difficult for innovator companies to navigate. Our goal is to assist clients developing medical countermeasures - which include vaccines, antivirals, antibiotics, antibodies, as well as surveillance and diagnostic devices - with the process of obtaining and managing high-value biodefense product approvals and government contracts. We have extensive relationships in key federal agencies and broad experience representing clients at the Department of Health and Human Service, the National Institutes of Health, the Center for Disease Control and Prevention, the Food and Drug Administration, the Department of Homeland Security and the Department of Defense. Through our expertise and contacts, our aim is to simplify the process and maximize our client’s efforts.

Lawyers in our Biodefense and Pandemic Preparedness group have:

  • Worked with HHS, Congressional Members and staff to craft legislation strengthening the nation’s response to pandemic outbreaks and bioterrorism, including Project BioShield and BARDA. 
  • Advised companies on obtaining government contracts for the advanced development of medical countermeasures including: pandemic influenza vaccines and antivirals; anthrax vaccines, botulism treatments, and surveillance devices. 
  • Advised early-stage companies on obtaining government grants for basic research and preclinical development. 
  • Assisted clients on medical countermeasure product filings and helped expedite the approval process. 
  • Educated clients regarding government procurement and stockpiling procedures. 
  • Provided strategic counsel to a coalition of leading venture capitalists in support of Congress’ passage of the All-Hazards Preparedness Act, which created BARDA.