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

3/11: Evaluating the Revised Diagnostic and Statistical Manual of Mental Disorders (DSM-5)

Evaluating the Revised Diagnostic and Statistical Manual of Mental Disorders (DSM-5)

Tuesday, March 11, 2014, 12:00pm

Wasserstein Hall 3018, Harvard Law School, 1585 Massachusetts Ave.

The DSM is the reference used by clinicians, researchers, and insurers to diagnose and classify mental disorders, with the intent to provide specific, objective criteria by which to assess symptoms and determine whether to pay for treatment.  The American Psychiatric Association released the manual’s fifth edition in May 2013, nearly twenty years after the fourth edition, to substantial public and professional criticism.  Please join us for a discussion of the new revisions and their implications for patients, medical practice, research, and the law.

Panelists:

  • Steven E. Hyman, Director of the Stanley Center for Psychiatric Research at the Broad Institute and Harvard University Distinguished Service Professor of Stem Cell and Regenerative Biology
  • Anne Becker, Maude and Lillian Presley Professor of Global Health and Medicine, Harvard Medical School
  • Nita Farahany, Professor of Law, Professor of Genome Sciences & Policy, and Professor of Philosophy at Duke University
  • Moderator: I. Glenn Cohen, Professor of Law, Harvard Law School; Faculty Co-Director, Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics

This event is free and open to the public. Lunch will be provided. For questions, contact petrie-flom@law.harvard.edu or 617-496-4662.

This event is supported by the Oswald DeN. Cammann Fund.

Global Health Governance: Call for Submissions

Global Health Governance will be publishing a special issue on a proposed Framework Convention on Global Health (FCGH) in December 2014. The proposal for an FCGH would create a new international framework, grounded in the international human right to health, that would support health at the national and global levels.

For this FCGH special issue, Global Health Governance invites submission of theoretical and empirical policy research articles that examine and analyze how the FCGH could improve health through improved governance and realization of the right to health. We have particular interest in articles on: Read More

Twitter Round Up

This week’s twitter round up features a variety of topics from our contributors, from the correlations between cancer survival rates and funding to blog posts about possible criminalization of drinking while pregnant.

Frank Pasquale tweeted that “there’s a direct correlation between funding and survival rates” regarding cancer from an entry of the blog “Every Breath I Take: A Blog about my Journey with Lung Cancer.”

Art Caplan tweeted about flu vaccinations again this week in order to bring the Rhode Island ACLU’s attention to the CDC’s determination that “getting the flu vaccine this season reduced risk of flu-related doctor’s visits by 61 percent.”

Amitabh Chandra tweeted an article from the Annals of Internal Medicine discussing bariatric surgery and its greater effects on weight loss and diabetes remission than nonsurgical measures to combat obesity.

Stephen Latham tweeted a link to his blog post about the “Criminalization of Drinking While Pregnant in the UK?” which discusses current “plans to bring legal action to establish liability for criminal damages by women who drink while pregnant, with resultant damage to their newborns.”

Professional Licensing Boards and Antitrust Liability

[Blogger’s Note: I am very pleased to share this post by my colleague at Seton Hall Law, Tara Adams Ragone, in which she discusses North Carolina Board of Dental Examiners v. FTC, drawing on both her scholarly work on the intersection of health care and antitrust law and on her deep experience prosecuting medical licensing actions for the state of New Jersey.]

By Tara Adams Ragone

Cross-Posted at Health Reform Watch

Should state professional boards, which regulate a growing and diverse array of professions and often are composed of professionals from the regulated community, be immune from federal antitrust liability if they engage in anticompetitive conduct?  The Federal Trade Commission thinks not in all cases, the Fourth Circuit agreed, and the North Carolina Board of Dental Examiners has asked the United States Supreme Court to review this decision.

Sasha Volokh recently devoted a 5-part series of blog posts to the major legal issues in play in this case.  He provides an overview of the antitrust state action immunity doctrine here, summarizes the facts underlying the case, North Carolina Board of Dental Examiners v. FTC, here, outlines the differing tests used in the circuits when applying the state action immunity doctrine to professional boards here, offers his opinion on how the Supreme Court ought to resolve these conflicts here (he leans towards the Fourth Circuit’s analysis), and suggests a possible way for the Board to work around the FTC’s injunction (by simply rephrasing its letters to threaten litigation) here.  Sasha’s posts provide an accessible and helpful primer on the case and relevant antitrust case law and are worth a read.

While we wait to learn if the Supreme Court will review this case, Professors Aaron Edlin and Rebecca Haw tackle the question of whether the actions of state professional licensing boards should be subject to antitrust scrutiny in their article, “Cartels by Another Name: Should Licensed Occupations Face Antitrust Scrutiny?” (available on SSRN and forthcoming in the University of Pennsylvania Law Review).  Although they use a question mark in their title, their characterization of licensing boards as cartels is a powerful tipoff to their ultimate conclusion – that licensing boards composed primarily of competitors regulating their own profession should not escape antitrust review: Read More

Hard Paternalism

Is hard paternalism in medicine ever justified?   In a recent NYT op-ed titled “When Doctors Need to Lie,” cardiologist and author Sandeep Jauhar provides a thought-provoking perspective on this question.

Dr. Jauhar begins with a description of a case in which the father of a 22-year-old patient requested that Jauhar temporarily lie and tell the patient that was going to be fine, even thought he was suffering from severe heart failure.  Jauhar agreed on grounds that the patient was not yet psychologically ready to hear the news and that withholding the information was therefore justified by the central principle that “physicians must do no harm.”

This example of temporary lying provides an avenue into a general discussion of the role of paternalism in medicine, which Jauhar argues should not be wholly displaced by respect for patient autonomy.   He argues that “when a doctor believes that a paternalistic approach is justified, he should aim to keep it as ‘soft’ as possible,” but that “there may be a place in medicine for hard paternalism, too.”

In support of hard paternalism, Jauhar describes a case in which one of his patients was bleeding into his lungs and was going to die without a breathing tube.   Jauhar knew that the patient had previously told other doctors that he never wanted to be intubated, but he did not know the quality of their discussion and could not find out because the patient was nearly unconscious.   So he intubated the patient, thereby saving his life.  And in the end, the patient thanked him.

But does this story actually offer support for hard paternalism? 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: Frances Kamm’s Bioethical Prescriptions: Book Talk and Panel Discussion

Please join us on February 27 at 2:00pm in Wasserstein 1019 at the Harvard Law School as we launch Professor Frances Kamm’s latest book, Bioethical Prescriptions: To Create, End, Choose, and Improve Lives (Oxford University Press, January 2014). The book showcases Professor Kamm’s articles on bioethics as parts of a coherent whole, with sections devoted to death and dying; early life (on conception and use of embryos, abortion, and childhood); genetics and other enhancements (on cloning and other genetic technologies); allocating scarce resources; and methodology (on the relation of moral theory and practical ethics).

Panelists include:

  • Frances Kamm, Littauer Professor of Philosophy & Public Policy, Harvard Kennedy School of Government; Professor of Philosophy, Faculty of Arts & Sciences, Harvard University; Former Senior Fellow, Petrie-Flom Center
  • Norman Daniels, Mary B. Saltonstall Professor of Population Ethics and Professor of Ethics and Population Health, Harvard School of Public Health
  • Thomas (Tim) Scanlon, Jr., Alford Professor of Natural Religion, Moral Philosophy, and Civil Polity, Faculty of Arts & Sciences, Harvard University
  • Moderator: Christopher T. Robertson, Visiting Professor of Law, Harvard Law School; Associate Professor, James E. Rogers College of Law, University of Arizona

This event is free and open to the public. For questions, please contact petrie-flom@law.harvard.edu or 617-496-4662.

Sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and BioethicsEdmond J. Safra Center for Ethics at Harvard University; and the Countway Library of Medicine at Harvard Medical School; with support from the Oswald DeN. Cammann Fund.

Peter Orszag on Medical Malpractice Reform that Works

Peter Orszag has a nice piece on the future of medical malpractice reform. In it he gives a big shout-out to former Petrie-Flom fellow (now Cornell Law Prof) Mike Frakes and discusses papers Mike worked on while at the Center. Hopefully policymakers are listening. From Orszag’s piece:

Capping damages for medical malpractice can do little to solve this problem, but changing the standard against which doctors are evaluated would. In particular, doctors should have a safe harbor from malpractice suits if they follow evidence-based protocols published by a professional medical association. The Center for American Progress and others have proposed exactly this type of approach, and have also provided details about how it could work.

Professor Michael Frakes of Cornell Law School has done pathbreaking research on the benefits of moving away from customary-practice rules. In a new analysis, Frakes and Anupam Jena, a professor of health-care policy at Harvard Medical School, examine how malpractice laws affect mortality rates, avoidable hospitalizations, adverse events to mothers during childbirth and other measures of health-care quality. They then assess two types of reforms: changes to damages caps and changes to the local customary-practice standard.