Pre-Approval Access Symposium: Can Compassion, Business, and Medicine Coexist?

Dates: October 28 – 29, 2015
Location: The New York Academy of Sciences, 7 World Trade Center, NYC
Presented by: NYU School of Medicine and the New York Academy of Sciences
Event URL: www.nyas.org/CompassionateUse

Explore challenges surrounding pre-approval access to investigational medicines through a series of debates featuring prominent representatives of governments, pharmaceutical companies, patient groups, NGOs, and foundations in this two-day colloquium.

Agenda topics include:

  • Perspectives from Patient Advocates on Compassionate Use and Expanded Access
  • The Case of Josh Hardy and Social Media’s Impact
  • Lessons Learned from the Ebola Virus Epidemic on Compassionate Use during a Crisis
  • Key Issues from Stakeholders’ Perspectives When Considering a Compassionate Use Request
  • Legislative or Regulatory Changes on Compassionate Use and Expanded Access

Read More

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 , 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.

Read More

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.  Read More

‘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

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.

Read More

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

10/20: 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: Read More

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