FSMA Conference Part 2: FSMA and Risk Regulation Strategy

[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.]

After Peter Hutt’s teriffic keynote speech, our first panel addresses the Food Safety Modernization Act and risk regulation strategies.  The speakers are Professor Jake Gersen of Harvard Law School, Director of the Food Law Lab, and Professor Michael Roberts, Founding Executive Director of UCLA Law School’s Resnick Center on Food Law and Policy. Read More

Dov Fox on the FDA’s ruling on 23andMe

Dov Fox has a new piece up at the Huffington Post on the 23andMe controversy: “Genetic Testing Needs a Nudge.” From the article:

Mail-away genetic testing promises to revolutionize the way that people learn about and manage their health. Already half a million Americans have sent their saliva to find out their risk of genetic disease — no doctors needed.

Splashed across TV sets nationwide this past summer was 23andMe’s invitation to discover “hundreds of things about your health,” including that you “might have an increased risk of heart disease, arthritis, [or] gallstones.”

Since the company’s inception in 2007, the government had allowed it to market and sell its at-home genetic tests free of regulation. For $99 and the click of a mouse, 23andMe promised a “first step in prevention” to “mitigate[e] serious diseases.”

But this winter, the Food and Drug Administration issued a letter forbidding sales of the test to diagnose health conditions unless there is evidence that it works for that purpose. Shortly after 23andMe announced that it had “suspended” all sales of its “health-related genetic tests to comply” with the FDA directive, consumers brought aclass action lawsuit against the company, alleging that it “falsely and misleadingly advertises” the genetic test “as providing ‘health reports on 240+ conditions'” in the absence of “analytical or clinical validation.”

The 23andMe controversy illustrates a stalemate over the role of direct-to-consumer genetic testing in American health care.

You can read the full piece here.

FDA, Mitochondrial Manipulation, Three Parent Children, and the NY Times

In yesterday’s NY Times Op-Ed page Marcy Darnovsky writes about FDA’s consideration of mitochondrial manipulation therapies later this week. As she describes it:

The F.D.A. calls them mitochondrial manipulation technologies. The procedures involve removing the nuclear material either from the egg or embryo of a woman with inheritable mitochondrial disease and inserting it into a healthy egg or embryo of a donor whose own nuclear material has been discarded. Any offspring would carry genetic material from three people — the nuclear DNA of the mother and father, and the mitochondrial DNA of the donor. 

As she writes in her opinion:

Some media accounts about these techniques have misleadingly referred to “saving lives,” as if they were aimed at people who are sick and suffering. Others have failed to note how very few women would be candidates for even considering them. And they could turn to safer and simpler alternatives. An affected woman could adopt or use in vitro fertilization with another woman’s eggs. Of course, the resulting child would not be genetically related to her, but neither would the child be put at grave risk by an extreme procedure.

The F.D.A. advisory panel says that its meeting will consider only scientific aspects of mitochondrial manipulation and that any “ethical and social policy issues” are outside its scope. But those are precisely the issues that we must address. Simply being able to do something doesn’t mean we should do it.

That conclusion is a bit pat, though I don’t fault her too much given how tight op-ed word limits are, and maybe a tad reactionary. I do think she raises an interesting point about how this is not saving lives, though I think so for different reasons.

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FSMA Conference Part I: Peter Barton Hutt on the Food Safety Modernization Act in Historical Perspective

[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 Ching-Fu Lin

On February 21, a group of scholars gathered at HLS to discuss new directions for food safety and challenges to the implementation of the 2011 Food Safety Modernization Act (FSMA).  The conference featured a keynote speech delivered by Peter Barton Hutt, who is commonly recognized as the food and drug law expert in this country.

Hutt is a senior counsel at the Washington, D.C. law firm Covington & Burling.  He also served as chief counsel for the Food and Drug Administration (FDA) from 1971 to 1975. Hutt has taught a full course at HLS on food and drug law for over 20 years and has co-authored an influential casebook in this area.

Bringing in his expertise in the historical development of food law, Hutt began with what he called “still the best statute” from the English experience in 1266.  At around that time, the English Parliament codified some early regulatory statutes (assizes) that prohibited the sale of any “corrupted wine” or of any meat, fish, bread, or water that was “not wholesome for Man’s body.”  These laws continued to (with amendments and supplements) be of reference power in England until 1884.  As articulated by Hutt, it would be sufficient for the FDA to do what it needs to do even when we take the core principle “not wholesome for Man’s body” and get rid of the entire rest of the food law.

Hutt then turned to another landmark development in the history of food law.  In 1820, Frederick Accum, a German chemist working in England, published Treatise on Adulteration of Food and Culinary Poisons.  The treatise had an immediate impact worldwide and triggered the modern development of food regulatory statutes in the United States and Europe.  Indeed, the languages used in such statutes (such as prohibitions against adulteration) are reflected in the design of the 1906 and 1938 legislations in the United States.

Read More

Public Lecture at Radcliffe Institute “The Ethicist’s and The Lawyer’s New Clothes: The Law and the Ethics of Smart Clothes” now Available on Youtube

As part of a public lecture series at the Radcliffe Institute on “Smart Clothes” I delivered a public lecture entitled “The Ethicist’s and the Lawyer’s New Clothes: The Law and Ethics of Smart Clothes.” The lecture is now available for viewing on youtube. As the promotional materials described the lecture: “From enhanced exosuits for members of the armed services to clothing that spies on you, I. Glenn Cohen focuses on legal and ethical issues pertaining to the future of smart clothes.” While CNN coverage of the lecture focused on the surveillance aspects of these clothes, I think the discussion of exosuits and enhancements may be more interesting to BOH readers.

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.

Kevin Outterson on the Search for New Antibiotics

Kevin Outterson appeared on NPR’s “Here & Now” to discuss the growing problem of antibiotic resistance and possible ways to incentivize development of new antibiotics. From the interview:

On the misuse of antibiotics

“We should think of this as a global resource that needs to be conserved and taken care of. So antibiotics should never be used inappropriately. In the country right now, we have something on the order of 23 million people who are getting antibiotics for ear aches. Most of those situations would resolve on their own in a couple of days. We also give antibiotics many times for people just because they have some sort of a common cold — it’s estimated 18 million prescriptions a year — doesn’t help anyone who has the common cold. It’s a complete waste.”

On the rise of antibiotic-resistant bacteria

“It’s frightened people for more than a decade. You mentioned at the top the 23,000 Americans who are dying from resistant infections. The CDC said on top of that, there’s another 14,000 dying from a horrible disease, intestinal disease, called Clostridium difficile [C-diff] in the United States. Together, that’s larger than the number of people who die in this country each year from AIDS. And we’re not — as bad as things are now, the more troubling aspects, or what might happen in five or 10 years if some sort of a pathogen was resistant to everything we had got out to the population. It sounds like a Hollywood movie.”

You can listen to the full interview here.

TOMORROW: Patents without Patents: Regulatory Incentives for Innovation in the Drug Industry

February 19, 2014 12:00 PM Wasserstein Hall 1015
1585 Massachusetts Ave., Cambridge

In the pharmaceutical industry, patents are the preeminent incentive for innovation in developing new drugs.  But patents aren’t the whole story; regulatory agencies also offer different forms of exclusivity—enforced by the agencies themselves—to encourage different forms of innovation in the industry.  This panel will discuss actual and potential roles for those rewards in the context of developing new drugs, new uses for old drugs, and new ways to make drugs, in both the United States and the European Union. Panelists include:

  • Benjamin N. Roin, Hieken Assistant Professor in Patent Law, Harvard Law School; Faculty Co-Director, the Petrie-Flom Center
  • W. Nicholson Price II, Academic Fellow, the Petrie-Flom Center
  • Timo Minssen, Associate Professor, University of Copenhagen Faculty of Law; Visiting Scholar, the Petrie-Flom Center
  • Moderator, Aaron Kesselheim, Assistant Professor of Medicine, Harvard Medical School; Director of the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital

This event is free and open to the public. Lunch will be served. For questions, contact petrie-flom@law.harvard.edu or  617-495-2316.

 

More on drug quality: India

By Nicholson Price

The New York Times had a troubling piece this weekend about major problems in drug quality in India, where FDA Commissioner Margaret Hamburg is visiting to discuss safety issues. India makes 40% of the U.S.’s generic prescription and over-the-counter drugs.

Quality issues seem to be unfortunately common (though of course there are many top-quality manufacturers and plants as well).  Half of all the FDA’s drug-related warning letters last year were issued to Indian plants, and recently popular drugs (including Neurontin and Cipro) have been banned from the United States if they’re manufactured in India.  Part of the explanation is differing standards for different markets; manufacturing standards are higher for the U.S. than for India, but the same companies are doing the manufacturing, sometimes at the same plants. Problems aren’t just about quality control in the plants – there are also major concerns with fraud.  In a particularly harrowing situation, “One widely used antibiotic was found to contain no active ingredient after being randomly tested in a government lab. The test was kept secret for nearly a year while 100,000 useless pills continued to be dispensed.”

(If you’re interested in pharmaceutical counterfeiting and are in New England, there’s what promises to be a terrific conference on pharmaceutical counterfeiting at UNH School of Law in Concord, NH on February 19 and 20; details are here.) Read More