The Future of Food Safety

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Food safety issues are once again in the news.  A large outbreak of E. coli O104:H4, centered in Germany, has sickened more than 3,000 people and killed 35.  After a lengthy investigation, German public health authorities believe the source of the E. coli to be bean and seed sprouts.

This recent outbreak highlights the need for strengthened national and international food safety regulation.  The United States took a large step toward improving food safety earlier this year by enacting the FDA Food Safety Modernization Act (FSMA). In a recent Commentary in the Journal of the American Medical Association, O’Neill Institute Faculty Director Larry Gostin and I addressed the improvements that the FSMA will bring to the U.S.’s food safety system.

As noted in the Commentary, food safety regulation is complex and improving safety requires efforts aimed at primary prevention, surveillance, and response.  The FSMA has been lauded for giving the FDA new mandatory recall authority for food, an enforcement tool it had lacked to date.  Though mandatory recall authority is an enormous boon for the FDA, the current crisis in Germany highlights the importance of a comprehensive “farm-to-table” food safety system.  Mandatory recalls can clearly only be applied when the source of the infection is known.  For this latest outbreak, identifying the source of the outbreak proved difficult.  By requiring producers to adopt preventive control plans and increasing inspections for production facilities, the FSMA moves the FDA toward a preventive approach to food safety. Read More

Posted in FDA, Uncategorized; Tagged: , , .


Launch of HealthLawandLigitation.com

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The National Health Law Program (NHeLP) and the O’Neill Institute are pleased to announce the launch of HealthLawandLitigation.com.

Since the enactment of the Patient Protection and Affordable Care Act (“ACA”), more than a dozen lawsuits have been filed in federal courts challenging the constitutionality of the law.  NHeLP and the O’Neill Institute have joined together to create a comprehensive clearinghouse of information about the litigation.  HealthLawandLitigation.com provides users with a schedule for all actions in all cases challenging the ACA; a compilation of briefs, motions, orders, and judgments as they are filed; notable Supreme Court precedents on the issues that are at the heart of the litigation; state ballot initiatives, legislation, and litigation related to the ACA; and legal and health policy scholarship pertaining to the litigation.

HealthLawandLitigation.com is meant as a practical resource for policymakers, practitioners, scholars, and for those interested in information about ongoing legislation, litigation, and scholarship relevant to the ACA.  NHeLP and the O’Neill Institute will ensure that the clearinghouse is kept regularly updated.  For additional information or questions, please contact nhelpdc@healthlaw.org or the oneillinstitute@law.georgetown.edu.

Posted in National Healthcare, Resources, Uncategorized; Tagged: , , , , , , , , .


World Health Assembly 2011 Outcomes and United Nations AIDS Review Preview

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Will the world’s premier health organization be able to reform itself to revive its global health leadership in the years ahead? Such was undoubtedly the question on the mind of health officials and civil society from around the world as they attended the 64th World Health Assembly (WHA) last month, the World Health Organization’s annual meeting of its governance body, comprised of all 193 of its Member States.

With WHO reform the marquee item on a crowded agenda that touched on many of the most pressing global health issues, this seemed destined to be a historic WHA.

And in some ways, it was – though at least in part, due to another issue. As the 2003 WHA secured its place in history by adopting the first global health treaty, the Framework Convention on Tobacco Control, and the 2005 WHA adopted the revised International Health Regulations, the 2011 WHA set the stage for greater international cooperation in responding to novel influenza viruses by adopting the Pandemic Influenza Preparedness Framework.

Pandemic Influenza Preparedness Framework

Despite being non-binding, and frankly underwhelming, it does for the first time set up a three-pronged global process of increase access of people in developing countries to vaccines and antiviral medication: 1) voluntary vaccine donations by vaccine manufacturers to a WHO stockpile to be used primarily in developing countries; 2) tiered pricing for vaccines and antivirals, and; 3) technology transfer for vaccines and antivirals. Manufacturers are also expected to contribute financially to support WHO’s global influenza surveillance and response system. Read More

Posted in Global Health, Uncategorized; Tagged: , , , , , , , , , , , , .


From Science Speaks Blog: Dybul on PEPFAR

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Note: The following is a re-post of the interview by John Donnelly, “Dybul on PEPFAR: ‘The sky was the limit,'” which was originally published on Science Speaks: HIV & TB News on June 2, 2011.  It is re-posted here with permission from Science Speaks.

John Donnelly, Dybul on PEPFAR: ‘The sky was the limit’

Ambassador Mark R. Dybul co-directs the Global Health Law Program at Georgetown University Law Center’s O’Neill Institute for National and Global Health Law, where he is also a Distinguished Scholar. He is the inaugural Global Health Fellow of the George W. Bush Institute. Dybul served as the U.S. Global AIDS Coordinator from 2006 to the end of the George W. Bush administration. In that role, he led the implementation of the President’s Emergency Plan for AIDS Relief (PEPFAR), the largest international health initiative in history for a single disease. Prior to assuming the post of ambassador, he was acting, deputy and assistant coordinator, and was a member of the Planning Task Force that created PEPFAR.  Dybul also led President Bush’s International Prevention of Mother and Child HIV initiative for the Department of Health and Human Services (HHS).

Dybul spoke with John Donnelly about the start of PEPFAR and some of the most memorable moments directing it, continuing Science Speaks’ series on 30 years of AIDS.

How did you first get involved in AIDS?
When I was in college, I was trying to decide whether to do a doctorate in theology or English, concentrating on poetry. Then I saw an article on AIDS on the cover of Newsweek, and something inside me said I should spend my life on this. I wound up pursuing it by going to medical school.

Later on you began working with Dr. Anthony Fauci. Tell me about that.
I started as a fellow in infectious diseases. The way the National Institutes of Health (NIH) works is, when you become a fellow you know what lab you are going to go into. I wound up accepted at Tony’s lab, and I did basic and clinical immunology and later some virology in his lab. I also started doing research in Africa with Peter Mugyenyi, and saw his programs and also programs run by TASO (The AIDS Service Organization) in Uganda. When Tony was asked by President Bush to think of what we could do on HIV, I was already working on the ground in Africa. Read More

Posted in Global Health, Uncategorized; Tagged: , , , , , , .


The World Health Assembly: Reforming the WHO and Global Governance for Health

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Note: An earlier version of this post, drafted by Eric A. Friedman, O’Neill Institute Law Fellow and Lawrence O. Gostin, O’Neill Institute Faculty Director, was disseminated as an O’Neill Institute Briefing on May 18, 2011.

In late May, the World Health Assembly (WHA) discussed an ambitious agenda of reform of the World Health Organization (WHO) and global governance for health—the norms, institutions, and processes that collectively shape the health of the world’s population. This post discusses WHA agenda items of major importance.

WHO Reform
The WHO faces at least a $300 million budget deficit and finds itself in an increasingly complex global health architecture characterized by great passion and innovation, but also fragmentation and lack of global leadership. Recognizing the need for reform to be more relevant to contemporary realities and to assume its proper global health leadership role, the World Health Organization is initiating a major reform process.

The WHO reform agenda includes: (1) a proposal for a global stakeholders’ forum to help shape the global health agenda; (2) clearer articulation of WHO’s unique role and functions; and (3) managerial reforms within WHO to increase its accountability to Member States, improve organizational structure, and revise its human resource strategy. One thing to look out for: the risk that as WHO seeks to define and organize itself along particular functions, such key areas as human rights, gender, primary health care, and the social determinants of health, which are officially to be “mainstreamed,” could in practice see their place within WHO downgraded. Read More

Posted in Global Health, Uncategorized, WHO; Tagged: , , , , , , , , , , , , , , , , .


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