Live Blogging from FDA in the 21st Century Conference, Panel 8: Food, Supplement, and Tobacco Regulation

[Live blogging off-the-cuff, so apologies in advance for any errors in summarizing, typos, etc]

Moderated by Emily Broad Leib, Harvard Law School

Robin Craig, Leslie Francis, and Erika George, University of Utah The FDA’s Authority Over Labeling: Current Ironies and Future Improvements:

Goal is to look at FDA authority over safety and labeling of Genetically Modified (GM) foods argue that FDA should do more, and argue for human right to food approach.

By GM we mean rDNA modification not husbandry and not careful selection.

FDA has moved to use guidance and policy. In particular two are relevant here. First, in food additives there is GRAS – Generally Recognized as Safe. E.g., Cinnamon was treated as GRAS. Manufacturers can self-determine a product is GRAS without notifying FDA, or, if in doubt, request a GRAS notice letter from FDA. This was proposed in 1997 and final review never issued, but this is how they do it. Has increased frequency of GRAS review request from FDA. But the process is voluntary and relies entirely on info from producer not scientific separate work by FDA.

In 1992, FDA issued a policy document related to GM foods. Stated no scientific evidence that GM foods have more safety concerns than existing husbandry techniques, so GM technology is NOT material information. This was NOT a conclusion that GM foods were GRAS.

In 1996, FDA issued a guidance for GM foods. Consultation process to determine whether there are material differences between GM version and non, voluntary process, encouraged to get consumer trust. Like GRAS totally voluntary, totally reliant on FDA data. 95 reported consultations between 1996 and 2012.

Alliance for Biointegrity v. Shalala, challenged in 2000 in D.D.C., court deferred to agency on safety questions and whether the info on GM was “material” and therefore needs to be disclosed.

Where would FDA get authority to regulate GM foods? May pose allergy risks? May be relevant to nutrition or quality. Maybe an additive not GRAS. But each of these arguments apply to specific GM food not GM foods as a whole.

Their argument: Consumers have a right to know so they can make their own consumption risks, and consumer or religious views are not merely preferences but a ground for the information that is material to consumers.

On why this is best understood as Human Right to Food. Adequate right to food is an HR right framed after WWII about enough food that is not adulterated and not against your faith or ethics (kosher, halal, vegan) and respectful of environment. U.S. is not part to Socioeconomic rights convention, which is most explicit protection of this right, but are signatories to other treaties that protect the right more indirectly.

Whole Foods has moved ahead on this as have others. Even if not a worry as GRAS, consumption may be inappropriate. We need a national strategy. More of a precautionary take that understands material to matter to consumers.

Jennifer Pomeranz, Yale, A Comprehensive Strategy to Overhaul FDA Authority for Misleading Food Labels:

Obesity and diabetes is the big problem in public health. And also people showing nutritional deficiencies because too much processed food. Current labeling is misleading makes people think food is healthier than they are. This is a unique public health problem. FDA has very weak authority and power here.

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Sleep No More: Sleep Deprivation, Doctors, and Error or Is Sleep the Next Frontier for Public Health?

[Cross-Posted at Prawfsblawg]

How often do you hear your students or friends or colleagues talk about operating on very little sleep for work or family reasons? In my case it is often, and depending on the setting it is sometimes stated as a complaint and sometimes as a brag (the latter especially among my friends who work for large law firms or consulting firms). To sleep 7-8 hours is becoming a “luxury” or perhaps in some eyes a waste – here I think of the adage “I will sleep when I am dead” expresses that those who need sleep are “missing out” or “wusses.” My impression, anecdotal to be sure, is that our sleep patterns are getting worse not better and that many of these bad habits (among lawyers) are learned during law school.

One profession that has dealt with these issues at the regulatory level is medicine. In July 2011, the Accreditation Council for Graduate Medical Education (ACGME) – the entity Responsible for the accreditation of post-MD medical training programs within the United States – implemented new rules that limit interns to 16 hours of work in a row, but continue to allow 2nd-year and higher resident physicians to work for up to 28 consecutive hours. In a new article with sleep medicine expert doctors Charles A. Czeisler and Christopher P. Landrigan that just came out in the Journal of Law, Medicine, and Ethics, we examine how to make these work hour rules actually work.

As we discuss in the introduction to the article

Over the past decade, a series of studies have found that physicians-in-training who work extended shifts (>16 hours) are at increased risk of experiencing motor vehicle crashes, needlestick injuries, and medical errors. In response to public concerns and a request from Congress, the Institute of Medicine (IOM) conducted an inquiry into the issue and concluded in 2009 that resident physicians should not work for more than 16 consecutive hours without sleep. They further recommended that the Centers for Medicare & Medicaid Services (CMS) and the Joint Commission work with the Accreditation Council for Graduate Medical Education (ACGME) to ensure effective enforcement of new work hour standards. The IOM’s concerns with enforcement stem from well-documented non-compliance with the ACGME’s 2003 work hour rules, and the ACGME’s history of non-enforcement. In a nationwide cohort study, 84% of interns were found to violate the ACGME’s 2003 standards in the year following their introduction.

Whether the ACGME’s 2011 work hour limits went too far or did not go far enough has been hotly debated. In this article, we do not seek to re-open the debate about whether these standards get matters exactly right. Instead, we wish to address the issue of effective enforcement. That is, now that new work hour limits have been established, and given that the ACGME has been unable to enforce work hour limits effectively on its own, what is the best way to make sure the new limits are followed in order to reduce harm to residents, patients, and others due to sleep-deprived residents? We focus on three possible national approaches to the problem, one rooted in funding, one rooted in disclosure, and one rooted in tort law. I would love reactions to our proposals in the paper, but wanted to float the more general idea in this space.

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More on NSF and NIH Funding

By Scott Burris

Here’s where some in Congress would like us to go:

ScienceInsider reports:

The new chair of the House of Representatives science committee has drafted a bill that, in effect, would replace peer review at the National Science Foundation (NSF) with a set of funding criteria chosen by Congress. For good measure, it would also set in motion a process to determine whether the same criteria should be adopted by every other federal science agency.

Whether or not you think of this as a partisan attack on science, it challenges the idea of science as an independent way of pursuing knowledge. The fact that this is even on the table, and could be taken seriously, shows how effective the attack on science has been.  It seems to reflect a terrible paradox:  on the one hand, social scientists are pissing some people off in a big way, which is a good sign we are doing something right in the inconvenient truth department; but on the other hand, I don’t see a lot of people rising to our defense, which suggest we matter to fewer people than we should.

This bill may or may not go anywhere, but anyone who cares about evidence-informed governance and the ability of the US to solve its problems ought to be concerned.


A Tale of Two Polities

By Scott Burris

Last week, Northeastern University’s effort to convene a much-needed conference on the future of health policy was a casualty of the successful manhunt for the Boston Marathon bombers.  One hardly wants to make too much of a stymied conference given all the human damage of the bombing and its aftermath, but all of us who had gathered for the meeting regretted that we would not hear from the panelists, and sympathized with organizers who had put so much into planning it.  In recognition of that, I am summarizing here what I planned to say there.  It is a tale of two polities that seem to compete for existence in our perceptions of the politics of public health.

One public health is incredibly popular with citizens and lawmakers alike – demonstrated by polling and passage of legislation.  I’ve recently blogged on this here.  The other public health is the despised nanny state, big government, the sequestered and slashed-to-the bone struggling provider of essential services that don’t get no respect and don’t deserve the meager tax dollars we still pay in. We see this in budget cuts, in hyperbolic allegations of “corruption,” and in disingenuous advocacy for a radical caveat emptor regime for all legal products.

What do we make of these two radically different views of where public health now stands in the public’s regard? My claim is that the former is largely the truth – public health is popular, not despised – but the latter view is what is driving budgets and a lot of policy. The action points follow: a sustained fight to mobilize public support and win more battles over budgets and laws. I see three main strands of work:

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Post-doc/Instructor Positions in Medical Ethics at NYULMC

The Division of Medical Ethics at the NYU Langone medical Center seeks to recruit two persons either as post-docs or instructors.

Applicants must demonstrate an excellent record of quality scholarship and teaching, and must have a PhD, JD, or MD. Successful applicants will be expected to demonstrate a strong scholarly career track in a sub-field of medical ethics/bioethics. The Division is especially interested in persons with research interests in neuroethics, reproductive technologies and ethics, public health ethics, transplantation ethics and mental health ethics. Read More

While We Sleep?

By Scott Burris

Nothing threatens a know-nothing more than the prospect of someone knowing something. Hence there has been increasing pressure on and from some in Congress to reduce government funding of social science research.  I hope every reader of this blog is aware that an appropriations rider added by Tom Coburn has drastically restricted NSF funding of political science research. That’s an ugly development, on par with the scandalous cuts to CDC that put paid to its gun research agenda years ago.

But the big funder of social and behavioral research in health is the NIH. In the past two weeks, I have heard via two different insiders that the agency is under pressure to significantly cut back on social and behavioral research, at least research with any important links to public policy. Now it is true that NIH does far too little policy-relevant research as it stands, but many fine researchers do important work related to law and policy with NIH support, and the important influence of law on health means we need more, not fewer, NIH-supported careers.

So I am hoping I am getting false information. What are you hearing?

Curbing Obesity: What Are We Doing?

[Ed. Note: Posted on behalf of Sarah Fudin, who works in community relations for the George Washington University’s online Master of Public Health program, dubbed MPH@GW, which offers students the ability to earn their MPH online.] 

The whole world knows that Americans are increasingly becoming obese, but solving the problem isn’t as easy as pointing it out. While the individual implications of obesity have been painfully clear for some time, there has been more discussion in recent years of how obesity impacts the economy. According to an infographic by MPH@GW, “The Cost of Obesity,” lowering the national obesity rate by just five percent could eliminate 13 percent of the federal deficit over the next 20 years. Re-framing the obesity epidemic in economic terms could be a way to persuade Americans to tackle obesity through public health legislation.

Support for Anti-Obesity Laws

Although the conventional wisdom in recent years has been that the American public resists public health laws, a recent study indicates that the public might actually be more welcoming of legislation than first thought. The study demonstrated that Americans tend to support non-intrusive public health legislation — bans on smoking in public places, for instance, but not bans on smoking in private residences. The key factor in rallying public support for a bill seems to be that the bill’s authors understand the public’s values, which may mean that it will be easier to pass public health laws as our national conversation about obesity evolves.

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4/25: Boston-Wide Forum on Global Access Licensing of Biomedically Relevant Technologies

by Adriana Benedict

Universities Allied for Essential Medicines (UAEM)
Boston-Wide Forum on Global Access Licensing of Biomedically Relevant Technologies

Thursday, April 25th, 3-5pm
Coffee and refreshments at 2:45pm; reception following the event
Harvard Medical School New Research Building – 77 Avenue Louis Pasteur
Seminar Room 1031

How do innovative medical technologies make their way to a global population, including patients in resource-limited settings? As centers of medical innovation, universities are well-placed to influence the global dissemination of the fruits of biomedical research and enhance access to advances in drug, vaccine, diagnostic and device technologies. In the past five years, several institutions in Boston and beyond have acknowledged this fact and taken bold steps to encourage the transfer of medical technologies to the developing world. Licensing provisions such as tiered, reduced and zero royalties for products sold in developing countries; march-in rights; agreements to agree; agreements not to patent or not to enforce patents in developing countries; and humanitarian licensing exceptions are just some of the strategies used to implement global access licensing of medical technologies.  Others can be found in UAEM’s Global Access Licensing Framework, as well as the multi-institution Statement of Principles and Strategies for the Equitable Dissemination of Medical Technologies.

In this Forum, technology transfer officials and academic research leaders from Harvard, MIT, Tufts, BU, Northeastern, Children’s Hospital and Partners Healthcare (MGH/BWH) will speak to their institutions’ philosophy and experience with global access licensing strategies. In an hour-long Q&A, the audience – including invited experts with significant experience in medical technology development – will contribute to the discussion. The Forum is open to the public; and researchers, entrepreneurs, university leaders and students are highly encouraged to attend.

UAEM is an international interdisciplinary student organization that works with universities to leverage academic research for global health. Since our founding in 2001, we have worked towards illuminating the poorly understood process that brings discoveries from the laboratory to widely accessible products and services meant to improve human health.

Registration through this link is appreciated, but not required.

This event is co-sponsored by grants from the Harvard Global Health Institute (HGHI), the HMS Division of Medical Sciences, and Harvard Law School Advocates for Human Rights.

Of Evergreening and Efficacy, Part II

By Ryan Abbott

I wrote earlier this month about the case between Novartis and the Union of India, in which the Supreme Court of India affirmed denying a patent for Novartis’ anti-cancer drug Glivec. Adriana Benedict added an insightful post about the case last week.

In my last post, I talked about the theory behind the decision and what it means for a drug to be therapeutically efficacious. Today and tomorrow, I thought it would be interesting to focus on the practical outcome of the case. In other words, what does this case mean for the access to medicines more generally, both in India and around the world?

Judging by recent public comments, this will be a landmark case. On the Novartis website, where the company is hosting an impressive array of resources devoted to the Glivec patent case, it states that this “decision discourages innovative drug discovery essential to advancing medical science for patients.” Eric Althoff, a Novaris spokesman said, if “innovation is rewarded, there is a clear business case to move forward. If it isn’t rewarded and protected, there isn’t.” On the opposite side of the spectrum, Indian Trade Minister Anand Sharma called the ruling “a historic judgment” that reaffirmed the position of Indian law requiring substantive innovation for patent protection. The Supreme Court itself noted that the “debate took place within a very broad framework. The Court was urged to strike a balance between the need to promote research and development in science and technology and to keep private monopoly (called an ‘aberration’ under our constitutional scheme) at a minimum.”

Despite the controversy, this case won’t necessarily have a wide ranging impact. It involved some unusual elements, which require historical background in India’s patent system to understand.

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