Does FDA Need a Dietary Supplement User Fee Act?

By Elizabeth Guo

Dietary supplements are dominating headlines these days – and not in a good way. Last Wednesday, Nevada officials found basketball star Lamar Odom unconscious at a brothel after taking cocaine along with ten pills of Reload, a sexual enhancement dietary supplement. That same week, the New England Journal of Medicine released an article finding that dietary supplements lead to roughly 23,000 emergency visits a year. Following these events, some officials have called on the Food and Drug Administration (FDA) to take a stronger role in regulating the dietary supplement industry.

Dietary supplements have had a long and storied past. As early as 1973, FDA tried to regulate dietary supplements regarding vitamin and mineral potency. The dietary supplement industry responded by challenging FDA in court, and Congress subsequently enacted the Proxmire Amendment, limiting FDA’s authority to regulate dietary supplements. However, by the 1990s, as consumers increasingly began to rely on dietary supplements, Congress passed the Dietary Supplement Health and Education Act of 1994, expanding FDA’s authority to regulate supplements by enacting special rules related to dietary supplement labeling and manufacturing.

Currently, FDA regulates dietary supplements as a special category of foods. Unlike manufacturers of over-the-counter drugs, dietary supplement manufacturers do not need to be registered with FDA and do not need list possible adverse events on supplement labeling. As Joanna Sax points out, this is a major problem because not all dietary supplements are the same. For example, certain weight loss or sexual enhancement supplements often contain chemicals associated with potentially serious side effects while other supplements containing chemicals such as Vitamin C pose less serious safety concerns.

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TOMORROW (10/20): Moral Bioprediction, Bioenhancement, and the Law – A Lecture by Julian Savulescu

DNA fingerprints.Moral Bioprediction, Bioenhancement, and the Law:
A Lecture by Julian Savulescu
October 20, 2015 12:00 PM
Pound Hall, Room 102, Harvard Law School,
1536 Massachusetts Ave., Cambridge, MA

Description: 

Increasingly, knowledge from biology and neuroscience allows us to identify biological states that are predictive but not determinative of human behavior in certain situations. These are called biomarkers of behavior. Looking at MAOA, a gene variant linked to increased criminal behavior in those who were maltreated as children, Professor Julian Savulescu will ask whether and how such behavioral biomarkers can ethically be used. Does the presence of the gene, or the presence of the gene in the right environment, affect moral or criminal responsibility? If so, does this affect the way we should respond to this group, either before or after they have committed any offence? Further into the future, could biology be modified to reduce the probability of violent offence?

Speakers: Continue reading

Medical Publications as Evidence

By Alex Stein

Whether a medical publication – a book or an article – can be used in court as evidence for its truth is determined by the “learned treatise” exception to the hearsay rule. This exception provides that a court can admit into evidence an excerpt from a treatise or periodical when it “is called to the attention of an expert witness on cross-examination or relied on by the expert on direct examination” and when “the publication is established as a reliable authority by the expert’s admission or testimony, by another expert’s testimony, or by judicial notice.”  Federal Rule of Evidence 803(18) and its state equivalents.

The Supreme Judicial Court of Massachusetts has recently narrowed this exception.  Continue reading

‘The Week in Health Law’ Podcast

By Nicolas Terry

twihl 14x14

For our first international episode this week we talked with Professor Deirdre Madden, a leading bioethicist and expert on health law at University College Cork in the Republic of Ireland. Professor Madden was author of the Report on Post-Mortem Practice and Procedure (2005) and Chairperson of the Commission on Patient Safety and Quality Assurance which published its Report, entitled Building a Culture of Patient Safety, in July 2008. She recently co-authored an overview of the national laws on electronic health records in the EU Member States. We opened with a discussion of some current trends in health law, including the EU/US Safe Harbour’s invalidation and recent developments in meaningful use. We then moved on to research regulation, with a brief mention of the US NPRM and more in-depth discussion of biobanking. Deirdre’s discussion of the Guthrie Cards in Ireland should be of great interest to those following developments in newborn screening and tissue storage in the US.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy.

Subscribe at iTunes, listen at Stitcher RadioTunein and Podbean, or search for The Week in Health Law in your favorite podcast app.

Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw

Monday, 10/19, HLS Health Law Workshop with Julian Savulescu

HLS Health Law Workshop: Julian Savulescu

October 19, 2015, 5:00 PM
Lewis International Law Center, Room 214A
1557 Massachusetts Ave, Cambridge MA 02138

Download the papers:
“The Ethics of Gene Editing”
“Mitochondrial Transfer Is Transplantation, Not Genetic Engineering”

Julian Savulescu is Uehiro Chair in Practical Ethics, Director of The Oxford Centre for Neuroethics, Director of the Oxford Uehiro Centre for Practical Ethics, and Director of The Institute for Science and Ethics, The Oxford Martin School. His areas of research include: the ethics of genetics, especially predictive genetic testing, pre implantation genetic diagnosis, prenatal testing, behavioural genetics, genetic enhancement, gene therapy; research ethics, especially ethics of embryo research, including embryonic stem cell research; new forms of reproduction, including cloning and assisted reproduction; medical ethics, including end of life decision-making, resource allocation, consent, confidentiality, decision-making involving incompetent people, and other areas; sports ethics; the analytic philosophical basis of practical ethics.  He is on the Advisory Board for the journal Neuroethics. Savulescu and Bostrom initiated the two year EU ENHANCE project, an interdisciplinary project devoted to studying the ethical implications of human enhancement and to providing detailed recommendations to European policy makers. Oxford led the cognitive enhancement theme. Savulescu is editor of two major collections on enhancement: one, co-edited with Bostrom, entitled Human Enhancement (OUP) and another draws on research from the ENHANCE project, entitled Enhancing Human Capacities (Wiley Blackwell, due for publication January 2011).

Before coming to Oxford in 2002 as Uehiro Chair in Practical Ethics, Professor Savulescu was Director of the Ethics Program at the Murdoch Children’s Research Unit, University of Melbourne, before which he studied for a Bachelor of Medicine and Surgery at Monash University, followed by a PhD under the supervision of Professor Peter Singer.

 

The Once and Future Cadillac Tax

cadillacOver the last few weeks, health economists have been defending the often politically friendless “Cadillac Tax.” This policy, as part of the Affordable Care Act, will begin taxing certain generous health insurance plans starting in 2018. Since World War II, the IRS has held that employer-sponsored health insurance should not been taxed, costing the federal government $329 billion in lost federal revenue. But, the most pivotal decision in the tax exemption status of employer-sponsored health insurance took place in 1954, not during World War II.

In 1954, when Congress extended the World War II provisions into permanent tax law, Congress decided to do away with the limits imposed on the tax-free status of health insurance. In essence, Congress has already repealed the Cadillac tax back when you could buy a new Cadillac for $5,000.

The Introduction of the Tax:

As part of the World War II price and wage controls, President Roosevelt’s National War Labor Board first put limits on wage increases and would not allow wages to increase greater than 15 percent of 1941 rates. Enterprising employers began offering health insurance coverage to recruit workers, because enticing workers with higher wages was not permitted. This forced the hand of the Board to address the tax status of health insurance.

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The Testosterone Rule

Dutee Chand is an Indian athlete that has been in the focus of a recent drama in elite sport. Chand, a gifted athlete and champion, was suspended from participating in competitions by the International Association of Athletics Federations (IAAF), after she was found to have high levels of testosterone. A biological condition called “hyperandrogenism” caused Chand to have three times more testosterone than an average woman athlete, similar to that of men. Chand was given the unappealing alternative of undergoing surgery and hormonal treatments meant to “normalize” her so she could race again, or turning to the Court of Arbitration for Sport (CAS), she chose the latter.

One would think that in a world in which men and women’s sports are so profoundly separated, distinguishing between male and female athletes would be a no-brainer.  Well, it’s not like that at all. Chand’s case can be traced along a history of similar episodes in which female athletes (like South African runner Caster Semanya and others) were suspected for not being “true females,” having to undergo medical scrutiny in order to conclude on the matter. This ambiguity is not special to athletes. It even has a name – “intersex,” an umbrella term describing a range of conditions in which the person’s sex cannot be conclusively determined. To read more on intersex variations click here.

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Book Launch (10/28)! FDA in the 21st Century: The Challenges of Regulating Drugs and New Technologies

lync17118_frontBook Launch: FDA in the 21st Century
October 28, 2015 12:00 PM
Wasserstein Hall, Milstein East C, HLS
1585 Massachusetts Ave., Cambridge, MA [Map]

In September 2015, Columbia University Press published FDA in the Twenty-First Century: The Challenges of Regulating Drugs and New Technologies, co-edited by Petrie-Flom Center Executive Director Holly Fernandez Lynch and Faculty Director I. Glenn Cohen. This edited volume stems from the Center’s 2013 annual conference, which brought together leading experts from academia, government, and private industry to evaluate the FDA and to begin charting a course for the agency’s future.

This event will provide a discussion of the book, including questions like: How is the agency faring in the 21st century? What are the greatest challenges to the FDA’s success, and what does success look like? What lessons has it learned and how can it best meet the challenges of today? Should we keep the agency we have, pull it apart, or rebuild from scratch?

Panelists:

  • Daniel Carpenter, Freed Professor of Government, Harvard University and Director, Center for American Political Studies at Harvard University
  • I. Glenn Cohen, JD, Professor of Law and Faculty Director of the Petrie-Flom Center, Harvard Law School (co-editor)
  • Aaron S. Kesselheim, MD, MD, MPH, Associate Professor of Medicine, Harvard Medical School; faculty member, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hosptial
  • Holly Fernandez Lynch, JD, MBioethics, Executive Director of the Petrie-Flom Center (co-editor)
  • Moderator: Ameet Sarpatwari, Instructor in Medicine, Harvard Medical School, and Associate Epidemiologist, Brigham and Women’s Hospital

This event is free and open to the public.

Order the book now from Columbia University Press using promo code FDA21 and save 30%!

Sponsored by the Harvard Law School Library and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.

‘The Week in Health Law’ Podcast

By Nicolas Terry

twihl 14x14

This week we talked with Scott Burris, who is a Professor of Law at Temple Law School, where he directs the Center for Health Law, Policy and Practice, and the Robert Wood Johnson Foundation’s Research on Policy and Law program. He is also a Professor in Temple’s School of Public Health. We discussed Scott’s extraordinary work at the National Coordinating Center for Policies for Action, the Policy Surveillance Program, and the Public Health Law Research National Program Office. Public health law tracking and assessment tools are meant to subject policymaking to rigorous, data-driven studies of comparative effectiveness and cost-benefit analysis. Consider, for example, recent controversies regarding the overall effect of helmet laws. Scott discussed the methodological questions raised by such assessments and law tracking, and new directions for public health law.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy.

Subscribe at iTunes, listen at Stitcher RadioTunein and Podbean, or search for The Week in Health Law in your favorite podcast app.

Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw

10/23: Harvard Reception at the ASBH 17th Annual Meeting

White Rose and Red WineHarvard Reception at the ASBH 17th Annual Meeting
October 23, 2015 8:00 – 9:30 PM
Hilton Americas-Houston, Meeting Room 339
1600 Lamar St., Houston, TX [Map]

Directors and staff from the Center for Bioethics at Harvard Medical School and the Petrie-Flom Center at Harvard Law School will welcome guests at ASBH’s 17th Annual Meeting to this gathering place for scholars doing bioethics and policy work at Harvard and others in the broader research ethics community. The reception will be a great opportunity to find out more about upcoming events, conferences, and opportunities to get involved.

ASBH – the American Society of Bioethics + Humanities – promotes the exchange of ideas and fosters multidisciplinary, interdisciplinary, and inter-professional scholarship, research, teaching, policy development, professional development and collegiality among people engaged in clinical and academic bioethics and the medical humanities.

This event is open to all registrants at the ASBH Annual Meeting.

Cosponsored by the Center for Bioethics at Harvard Medical School and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.

“Medical Malpractice or Ordinary Negligence?” in the Context of Psychiatric Treatment

By Alex Stein

“Medical Malpractice or Ordinary Negligence?” is an issue that will stay on the courts’ agenda for long. See hereherehereherehere, here, and here.

As I explained in these posts and in a foundational article on medical malpractice, categorizing a plaintiff’s action as “medical malpractice” rather than “ordinary negligence” determines whether it must satisfy rigid limitations and repose provisions, comply with special and costly requirements with regard to expert testimony, face the difficult burden of proving the defendant’s deviation from the medical profession’s customary practices and protocols, and suffice itself with the compensation amounts allowed by the statutory caps on damages.

A recent Florida court decision, Shands Teaching Hosp. & Clinics v. Estate of Lawson, — So.3d —- 2015 WL 5057325 (Fla. 5th DCA 2015), illustrates the centrality of this issue for suits complaining about a psychiatric hospital’s neglect. Continue reading

10/20: Moral Bioprediction, Bioenhancement, and the Law – A Lecture by Julian Savulescu

DNA fingerprints.

Moral Bioprediction, Bioenhancement, and the Law:
A Lecture by Julian Savulescu
October 20, 2015 12:00 PM
Pound Hall, Room 102, Harvard Law School,
1536 Massachusetts Ave., Cambridge, MA


Description: 

Increasingly, knowledge from biology and neuroscience allows us to identify biological states that are predictive but not determinative of human behavior in certain situations. These are called biomarkers of behavior. Looking at MAOA, a gene variant linked to increased criminal behavior in those who were maltreated as children, Professor Julian Savulescu will ask whether and how such behavioral biomarkers can ethically be used. Does the presence of the gene, or the presence of the gene in the right environment, affect moral or criminal responsibility? If so, does this affect the way we should respond to this group, either before or after they have committed any offence? Further into the future, could biology be modified to reduce the probability of violent offence?

Speakers: Continue reading

Panel (10/15): Is Professional Football Safe? Could We Make It Safer? Perspectives from Neuroscience, Law, and Ethics

College football on grass field in afternoon sunlight

Join us for a panel discussion as part of the 2015 Annual Meeting of the International Neuroethics Society!
October 15, 2015 Panel: 5:00 – 6:30 PM, Reception: 6:30 – 7:15 PM
Northwestern University Hughes Auditorium
303 E. Superior Street, Chicago, IL

Professional football has come under significant scrutiny in recent years, particularly because of concerns over player health and safety.  While concussions are most often discussed, players also face a variety of other health risks, from joint and muscle problems to cardiac malfunction to issues with chronic pain. But health risks are just one part of story. So, too, are the potential short and long-term benefits these exceptional athletes may reap from the game.

Come learn more about the debate, and about The Football Players Health Study at Harvard University, which seeks to understand and improve the health and wellbeing of former NFL players. This study looks at the risks and benefits of playing football at the professional level over the life of the player, supports novel discoveries and new therapies, and seeks to improve the systems and organizational structures that may affect player health.

Panelists: Continue reading

10/14: Webcast on the NIH’s Efforts to Support Translational Science

This month’s Regulatory Science Series presentation features Dr. Keith Joiner, MD, MPH, the Director of the Center for Management Innovations in Health Care at the Eller College of Management, and former Dean of the University of Arizona College of Medicine. He will present on NIH Efforts to Support Translational Science and discuss the importance of government funding policy to the regulatory science endeavor.

This event will stream live at 12:00 PM MT on Wednesday, October 14, 2015, at:  https://streaming.biocom.arizona.edu/event/index.cfm?id=26072.

The University of Arizona Regulatory Science Program is a partnership with the James E. Rogers College of Law and University of Arizona Health Sciences.

Bioethicist Art Caplan: No time to waste – the ethical challenges created by CRISPR

Bill of Health Contributor Art Caplan has a new article in EMBO Reports:

The term “CRISPR” has gained a lot of attention recently as a result of a debate among scientists about the possibility of genetically modifying the human germ line and the ethical implications of doing so. However, CRISPR is not just a method to edit the genomes of embryonic cells, as the public discussion might have implied; it is a powerful, efficient, and reliable tool for editing genes in any organism, and it has garnered significant attention and use among biologists for a variety of purposes. Thus, in addition to the discussion about human germ line editing, CRISPR raises or revives many other ethical issues, not all of which concern only humans, but also other species and the environment.

Continue reading

Symposium “Interprofessional Collaboration in Public Health Law and Policy: Moving the Needle on Social Determinants of Health”

Hall Center for Law and Health: Indiana Health Law Review Symposium, IU McKinney School of Law,  IU Fairbanks School of Public Health, the IU School of Social Work and the IU Center for Interprofessional Health Education and Practice present a cutting edge conference on Interprofessional Collaboration.

Click here for details and registration. Speakers include:Untitled

  • Charity Scott
  • Ross D. Silverman
  • Anna Kirkman
  • Elizabeth Tobin-Tyler
  • Bruce Jansson
  • Peter Jacobson
  • Andrea Pfeifle
  • Micah Berman
  • Heather A. McCabe
  • Eric Wright
  • Corey Davis
  • Chad Priest
  • Fran Quigley
  • Sula Hood
  • Joan Duwve
  • David Orentlicher
  • Nicolas Terry

Artemisinin: Worthy of Nobel Prize, but Growing Concerns About Resistance

Artemisinin, a drug used to treat malaria, has been a recent topic of public discussion after its discovery was recognized with the Nobel Prize in Physiology or Medicine on October 5. The 2015 prize was awarded to three researchers who developed treatments for parasite-caused diseases, with half the award going to Youyou Tu, who is credited with the discovery of artemisinin. Artemisinin has benefited hundreds of millions of people around the world. Yet the recognition for artemisinin’s discovery comes at a time when public health officials are becoming more concerned about its ongoing effectiveness and struggling to implement policies to slow the spread of artemisinin resistance. Continue reading