Foley Hoag - Biodefense and Pandemic Preparedness

Foley Hoag Launches Healthcare Law and Policy Blog

Thu, 17 Jun 2010 09:11:44 EDT

Eight lawyers from Foley Hoag’s Government Strategies practice have launched the Healthcare Law and Policy Blog, a timely resource focusing on regulatory issues, Medicare coverage and reimbursement, healthcare compliance and investigations, legislative representation, physician practice issues and health information, privacy and security in the healthcare and life sciences industries.

Thomas Barker, Former General Counsel of the U.S. Dept. of Health & Human Services, Joins Foley Hoag’s Washington Office

Fri, 02 Apr 2010 10:47:40 EDT

Foley Hoag LLP announced that Thomas Barker, the former acting General Counsel at the Department of Health and Human Services (HHS) and a legislative veteran who has worked on health care policy issues on both sides of the aisle, has joined the firm as a partner in its Healthcare and Life Sciences practices.

Foley Hoag Co-Hosts Congressional Briefing on Biodefense

Mon, 05 Apr 2010 18:10:07 EDT

Since 2001, the previous Administration and Congress drafted comprehensive policy documents, enacted major legislation and approved significant appropriations addressing the risks associated with the bioterrorism threat and the need for biodefense preparedness. Foley Hoag is playing a key role in educating and informing the new Administration and Congress on these issues through a series of educational briefings.

National Biodefense Science Board Presents Recommendations

Mon, 05 Apr 2010 18:14:39 EDT

The Assistant Secretary for Preparedness and Response (ASPR), Dr. Nicole Lurie, requested that the NBSB take a leadership role in the Public Health Emergency Medical Countermeasure Enterprise (PHEMCE) review currently underway at ASPR. The NBSB's Medical Countermeasures Research and Development Working Group, as well as the Medical Countermeasures Markets and Sustainability Working Group have been developing background on these issues since early 2008.

Government Asked to Provide Certainty and Incentives for Countermeasure Development

Mon, 05 Apr 2010 18:02:59 EDT

This week, the Institute of Medicine convened a workshop to examine federal policies and activities related to discovery through approval of medical countermeasures for responding to public health emergencies. Another meeting also took place this week which was organized by the National Biodefense Science Board to review the management and structure of the countermeasures development program.

Protecting the Nation Against Bioterrrorism

Thu, 01 Apr 2010 15:54:47 EDT

Foley Hoag lawyers in the Biodefense and Pandemic Preparedness practice regularly counsel clients on government affairs and business strategy in the development and distribution of products focused on medical countermeasures to terrorism and pandemics. Recently, the firm assisted a client, one of the Nation’s leading developers of effective countermeasures against biological and chemical weapons, in securing research and development funding for a second generation recombinant protective antigen (rPA) anthrax vaccine. The company may also be eligible to sell these critical products to the Federal Government under Project BioShield and authorities created as part of BARDA in 2008. Foley Hoag lawyers provide strategic government counseling and advocacy to secure support for these important biodefense countermeasures.

Enacting Legislation: the Biomedical Advanced Research and Development Authority (BARDA)

Wed, 21 Apr 2010 15:53:19 EDT

In a move that created enormous opportunities for early-stage life sciences companies, the U.S. Congress revitalized the federal government’s program supporting the development of medical countermeasures critical to protecting the nation against bioterrorism and pandemic threats. The resulting legislation created an agency within the Department of Health and Human Services (HHS), the Biomedical Advanced Research and Development Authority (BARDA). BARDA will inject more than $1 billion into research, development, and procurement of vaccines, antivirals and diagnostics. BARDA enhances coordination between government and emerging companies through support of advanced research and development, the vital phase that occurs in between basic research and commercialization. On behalf of a leading venture capital firm Foley Hoag worked with the HHS, Congressional members, and staff to craft legislation strengthening the nation’s response to pandemic outbreaks and bioterrorism. The key financing aspect of the legislation provides much-needed funding to allow early stage companies to traverse the "valley of death" before product commercialization. The legislation authorizes the Secretary of HHS to expedite contracts and grants, and the Director of BARDA to identify areas of unmet need, spurring further innovation and investment. BARDA institutionalizes the important partnership between the federal government and the life sciences industry, critical to safety, innovation and economic vitality.

Supplying the Nation with H1N1 Vaccine

Thu, 01 Apr 2010 15:55:04 EDT

In response to the significant demand last year for live H1N1 vaccines, Foley Hoag assisted leading biotechnology companies with securing contracts with the U.S. Department of Health and Human Services (HHS) to supply the H1N1 vaccine. These vaccines were approved by the U.S. Food and Drug Administration (FDA) and provided to health care facilities in advance and during the 2009 influenza season. Lawyers in the firm’s Life Sciences and Government Strategies practice, working as part of a specialized team focused on biodefense and pandemic issues, provide regulatory counsel from early product development to FDA approval, and through the Federal government procurement process.

Promoting Advanced Technology to Improve Security, Public Health

Thu, 01 Apr 2010 15:56:28 EDT

A leading global medical device company asked lawyers in Foley Hoag’s Biodefense and Pandemic Preparedness practice to help secure funding and FDA approval for its next-generation biosurveillance system. The system is a novel technology platform that can identify H1N1 and other emerging infectious diseases, counter bioterrorist attacks more quickly, and help prevent the spread of foodborne illness, more quickly and comprehensively than competing technologies. The system has significant potential applications in academic laboratories, military facilities, numerous government agencies, and in health care settings, such as hospitals and clinical laboratories. Foley Hoag lawyers provide regulatory counsel and government strategy development to secure government and congressional support for new devices in the biodefense space.

Accelerating Innovation Against Emerging Threats

Thu, 01 Apr 2010 15:57:23 EDT

Foley Hoag’s Biodefense and Pandemic Preparedness practice was successful in securing funding in Department of Defense appropriations for research on the efficacy of combination influenza antivirals. The funds were allocated to a small biotechnology company through an agreement with the United States Naval Health Research Center. The public-private collaboration betweenCongress and the U.S. Navy with private and nonprofit researchers significantly advanced the company’s efforts to develop antiviral therapy in response to the influenza pandemic. Foley Hoag lawyers provide strategic guidance and help educate Congress and the Administration on the critical importance of promoting the development of new medical countermeasures against serious public health and security threats.