DUE 6/3: Call for Abstracts: Emerging Issues and New Frontiers for FDA Regulation

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The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Food and Drug Law Institute are pleased to announce an upcoming collaborative academic symposium:

Emerging Issues and New Frontiers for FDA Regulation

Monday, October 20, 2014 

Washington, DC

We are currently seeking abstracts for academic presentations/papers on the following topics:  Read More

Call for Abstracts: Emerging Issues and New Frontiers for FDA Regulation

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The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Food and Drug Law Institute are pleased to announce an upcoming collaborative academic symposium:

Emerging Issues and New Frontiers for FDA Regulation

Monday, October 20, 2014 

Washington, DC

We are currently seeking abstracts for academic presentations/papers on the following topics:

  • Stem cell therapies
  • Nanotechnologies
  • Genetic (and biomarker) tests
  • Gene therapies
  • Personalized medicine
  • Comparative efficacy research
  • Drug resistant pathogens
  • Globalized markets
  • Tobacco
  • GMO
  • Bioterrorism countermeasures
  • Mobile health technologies
  • Health IT
  • Drug shortages
  • Other related topics

Abstracts should be no longer than 1 page, and should be emailed to Davina Rosen Marano at dsr@fdli.org by Tuesday, June 3, 2014. Questions should also be directed to Davina Rosen Marano.

We will notify selected participants by the end of June.  Selected participants will present at the symposium, and will be expected to submit a completed article by December 15, 2014 (after the event) to be considered for publication in a 2015 issue of FDLI’s Food and Drug Law Journal (FDLJ).  Publication decisions will be made based on usual FDLJ standards.

FSMA Conference Part 4: Benefits, Challenges, and Gaps in FSMA’s Approach

[Ed. Note: On Friday, the Petrie-Flom Center, the Food Law and Policy Clinic (a division of the Center for Health Law and Policy Innovation), the Food Law Lab, and the Harvard Food Law Society (with support from the Top University Strategic Alliance and the Dean’s Office at Harvard Law School) co-sponsored a conference at HLS called “New Directions for Food Safety: The Food Safety Modernization Act and Beyond.”  This week, we will be sharing a series of blog posts from the event, and video will follow shortly.]

By Jeffrey Skopek

Lewis Grossman, Washington College of Law, American University – New Governance, New Challenges

Professor Grossman opened the panel by locating FSMA in the context of the “new governance” movement that has arisen in response to the limits of command and control regulation.   Read More

FSMA Conference Part 3: Regulating Farm Production: From Zero to Sixty

[Ed. Note: On Friday, the Petrie-Flom Center, the Food Law and Policy Clinic (a division of the Center for Health Law and Policy Innovation), the Food Law Lab, and the Harvard Food Law Society (with support from the Top University Strategic Alliance and the Dean’s Office at Harvard Law School) co-sponsored a conference at HLS called “New Directions for Food Safety: The Food Safety Modernization Act and Beyond.”  This week, we will be sharing a series of blog posts from the event, and video will follow shortly.]

By Jason St. John, JD candidate, Harvard Law School

The third conference session, “Regulating Farm Production: From 0 to 60,” was moderated by Robert Greenwald, Director of the Center for Health Law Policy and Innovation at Harvard Law School. To make the presentations more cohesive, the presenters divided each of their fifteen-minute presentations into two seven-minute presentations. The panel discussed the FDA’s proposed Produce Safety rule under the Food Safety and Modernization Act (FSMA), the rule’s focus on produce and growing of food, and the large question of whether FSMA makes our food safer.

Read More

TOMORROW: “New Directions in Food Safety” conference at Harvard Law School

This one-day conference will bring together experts in food law and regulation to discuss a range of issues including food safety, agriculture, risk regulation strategy, and international issues.

Speakers are:

  • Keynote: Peter Barton Hutt, Harvard Law School/Covington & Burling
  • Alli Condra, Food Law and Policy Clinic, Harvard Law School
  • Marsha Echols, Howard University School of Law
  • Jacob E. Gersen, Food Law Lab, Harvard Law School
  • Lewis Grossman, Washington College of Law, American University
  • Ching-Fu Lin, Petrie-Flom Center, Harvard Law School
  • Sharon Mayl, Senior Advisor for Policy, FDA Office of Foods and Veterinary Medicine
  • Kuei-Jung Ni, Petrie-Flom Center, Harvard Law School/Institute for Technology Law, National Chiao Tung University, Taiwan
  • Margot Pollans, Resnick Food Law and Policy Program, UCLA School of Law
  • Michael Roberts, Resnick Food Law and Policy Program, UCLA School of Law
  • Denis Stearns, Seattle University School of Law
  • Stephanie Tai, University of Wisconsin School of Law

For the full agenda, including paper titles, please visit our website.

This event is free and open to the public, but space is limited and registration is required. To register, please click here.

For questions contact petrie-flom@law.harvard.edu or 617-496-4662.

Sponsored by the Petrie-Flom Center; the Food Law and Policy Clinic (a division of the Center for Health Law and Policy Innovation); the Food Law Lab; and the Harvard Food Law Society; with support from the Top University Strategic Alliance and the Dean’s Office at Harvard Law School.

2/21: “New Directions for Food Safety” — conference at Harvard Law School

This one-day conference will bring together experts in food law and regulation to discuss a range of issues including food safety, agriculture, risk regulation strategy, and international issues.

Speakers are:

  • Keynote: Peter Barton Hutt, Harvard Law School/Covington & Burling
  • Alli Condra, Food Law and Policy Clinic, Harvard Law School
  • Marsha Echols, Howard University School of Law
  • Jacob E. Gersen, Food Law Lab, Harvard Law School
  • Lewis Grossman, Washington College of Law, American University
  • Ching-Fu Lin, Petrie-Flom Center, Harvard Law School
  • Sharon Mayl, Senior Advisor for Policy, FDA Office of Foods and Veterinary Medicine
  • Kuei-Jung Ni, Petrie-Flom Center, Harvard Law School/Institute for Technology Law, National Chiao Tung University, Taiwan
  • Margot Pollans, Resnick Food Law and Policy Program, UCLA School of Law
  • Michael Roberts, Resnick Food Law and Policy Program, UCLA School of Law
  • Denis Stearns, Seattle University School of Law
  • Stephanie Tai, University of Wisconsin School of Law

For the full agenda, including paper titles, please visit our website.

This event is free and open to the public, but space is limited and registration is required. To register, please click here.

For questions contact petrie-flom@law.harvard.edu or 617-496-4662.

Sponsored by the Petrie-Flom Center; the Food Law and Policy Clinic (a division of the Center for Health Law and Policy Innovation); the Food Law Lab; and the Harvard Food Law Society; with support from the Top University Strategic Alliance and the Dean’s Office at Harvard Law School.

 

Genetically Modified Crops

The USDA’s Animal and Plant Health Inspection Service (APHIS) has released a Draft Environmental Impact Statement associated with its deregulation of a new generation of genetically modified herbicide-resistant crops.   While many in the agricultural industry hail this as a much-needed step in the development of new weed-control technologies, critics worry that it will accelerate an “herbicide treadmill” at the cost of more sustainable management strategies.

As a bit of background, the development of the first generation of genetically modified (GM) herbicide-resistant crops revolutionized agricultural weed management in the mid 1990s.  Prior to this development, weed management required significant skill and knowledge.  Farmers had to not only carefully manage the timing of various herbicide applications, but also integrate other nonchemical control practices.  Herbicide-resistant crops, by contrast, were effective and easy to use.

During the initial phase of development, a variety of GM options came to market, but Monsanto’s “RoundupReady” varieties (which are resistant to a broad-spectrum herbicide known as “glyphosate”) quickly became dominant.   By 2008, 63% of corn fields and 92% of soybean fields in the US were being planted with RoundupReady seeds.  The outcome of this single-track approach to weed management has been a dramatic increase in the number of weed species that are resistant to the herbicide glyphosate.

In response to the evolution of these “super weeds,” Congress has held hearings to assess whether additional government oversight is needed to address the problem.  The response of the seed and agrichemical industries, by contrast, has been to develop new GM seeds that are resistant to other broad-spectrum herbicides for which weeds have not yet developed resistance.  Read More

REGISTER NOW: “New Directions for Food Safety” conference at Harvard Law School

This conference will bring together scholars to discuss a range of issues related to the Food Safety and Modernization Act, including FSMA and risk regulation strategy; regulating farm production; benefits, challenges, and gaps in FSMA’s approach; and international issues and trade implications.

Speakers include:

  • KEYNOTE: Peter Barton Hutt, Harvard Law School/Covington & Burling – The Food Safety Modernization Act in Historical Perspective

Read More

Significant paper on GMO food risks retracted

By Nicholson Price

In the debate over whether genetically modified organisms should be allowed in the food supply or labeled when they’re used, a central question is whether GMOs are any more dangerous to people eating them than other foods.  This is far from the only concern raised by GMOs—that list includes things like the dangers of pervasive monoculture over diversity, intellectual property issues about crop ownership, the loss of traditional food sources, and the unintentional spread of modified organisms—but it’s a big one, and a major lever of consumer engagement.

In this debate, a significant piece of evidence frequently cited by the anti-GMO camp was a 2012 study by Seralini et al. that rats fed Roundup-ready corn were more likely to develop cancers (Roundup-ready corn is sold by Monsanto and is resistant to its popular herbicide Roundup).  I say was because the journal, Food and Chemical Toxicology, has just retracted the paper.  The paper was hugely controversial—which certainly isn’t justification for retraction—but that controversy prompted the editors to take a closer look at the raw data, after which they concluded that the number of rats studied was too low to justify the paper’s conclusions.

This episode unfortunately illustrates, among other things, the problems with intense media attention to early scientific reports, and with research-as-weapon rather than research-as-information.  Part of the hubbub came from the draconian embargo imposed on journalists before the article was published: because journalists weren’t permitted to seek any independent evaluation before publication of the article, many media reports ran enthusiastic coverage of the article before the scientific community started pointing out the many flaws in the research.  The eventual feedback from the scientific community—part two of peer review, when publications are criticized in the literature and addressed by letters and other publications—was certainly powerful, and led to the retraction.  But that doesn’t change the fact of its initial publication, and I’d bet quite a bit that the article will be cited for years to come as evidence that there’s not scientific consensus on this issue.  In fact, in a depressingly unsurprising development, Seralini is threatening to sue the journal over the retraction.

(For more on GMOs on Bill of Health, Kuei-Jung Ni just posted about the failure of the GMO-labeling initiative in Washington state, Glenn Cohen has written on the frankenburger, and I’ve written briefly about GMO crops spreading and intellectual property issues with GMO seeds.)

GM Food Labeling: An Unfinished Battle

By Kuei-Jung Ni

In Washington state, a proposal (Initiative 522) to require labeling of genetically modified (GM) or engineered (GE) foods was defeated recently by votes of 45.17% in favor and 54.83% against. The state law would have implemented mandatory labeling requirements on food composed of 0.9% or more of GM ingredients, measured by weight. Prospects for passage of the proposal were quite promising when it was first introduced. But, the scenario shifted when GM food companies, including General Mills, Nestle USA, PepsiCo, Monsanto, etc., launched a multi-million dollar advertisement campaign challenging the justification for GM labeling.

The downfall of the proposal, while disappointing consumer groups, is not likely to stop the labeling movement. Actually, there have been many other attempts to regulate GM foods on a state level. California Proposition 37, which would have imposed labeling requirements similar to the Washington proposal, was put to a vote last year, but failed to pass. According to Just Label It, a NGO, more than 20 state laws were introduced about GM labeling this year.

Many scientists trust the safety of GM foods, and the benefits brought by the development of GM agriculture are obvious. GM crop production can reduce the use of pesticides and enhance yields. By contrast, in addition to possible new allergies caused by the consumption of GM foods, some worry about their potential harm to the environment and ecological system. On the federal level, three agencies are competent to regulate GM crops and foods: the Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), and the Environmental Protection Agency (EPA), which use existing rules to regulate. Yet, the inadequacy of their oversight has been disclosed. Until now, no specific federal law has been enacted to regulate GM food production and consumption.

Read More