- Diana Winters, Intractable Delay and the Need to Amend the Petition Provisions of the FDCA, SSRN/Ind L.J.
- Xiaoyan Huang and Meredith Rosenthal, Transforming Specialty Practice — The Patient-Centered Medical Neighborhood, N Engl J Med
- Ameet Sarpatwari, Jerry Avorn, and Aaron S. Kesselheim, Using a Drug-Safety Tool to Prevent Competition, N Engl J Med
- Adam Candeub, Digital Medicine, the FDA, and the First Amendment, SSRN/Ga. L.Rev.
In honor of last week’s National Public Health Week, we have a lot of fresh, new PHLR. The latest crop of papers from public health law researchers touch on a number of important points and issues including transportation safety, implementation, tobacco control, and media presentation of public health law. Check out Scott Burris’s brief summaries after the jump!
- Nicholas Bagley, The Legality of Delaying Key Elements of the ACA, N Engl J Med
- Timothy Jost and Simon Lazarus, Obama’s ACA Delays — Breaking the Law or Making It Work?, N Engl J Med
- Michael Frakes, The Surprising Relevance of Medical Malpractice Law, SSRN/Chicago L. Rev.
- Sallie Sanford, Emergency Response: A Systemic Approach to Diaper Rash, Chest Pain and Medicaid in the ED, SSRN/Ky L.J.
- Aaron Kesselheim & Michelle M. Mello, Prospects for Regulation of Off-Label Drug Promotion in an Era of Expanding Commercial Speech Protection, SSRN/N.Ca. L.Rev.
Check out the April 4 edition of the Petrie-Flom Center’s biweekly e-newsletter for the latest on events, affiliate news and scholarship, and job and fellowship opportunities in health law policy and bioethics.
- Charity Scott, Ethics Consultations and Conflict Engagement in Health Care, SSRN/Cardozo J. of Conflict Resolution
- Dan L. Burk, The Curious Incident of the Supreme Court in Myriad Genetics, SSRN/Notre Dame L.Rev.
- Brendan Saloner et al, Pinching the Poor? Medicaid Cost Sharing under the ACA, N Engl J Med
- Amanda Pustilnik, Painful Disparities, Painful Realities, SSRN
- Ryan Abbott, Documenting Traditional Medical Knowledge, SSRN/WIPO
In the last few decades, there has been a broad effort to strengthen the use of evidence-based law as a tool for the promotion of population health. There are two major fronts in the campaign, each essential, and both largely successful, though much work also remains. One aims to increase the quantity and quality of empirical research on the health effects of existing policy choices. The other focuses on how best to get such knowledge into action in the form of policy and practice. In a new PHLR Theory Practice and Evidence paper, Evan Anderson and I draw attention to a third front: the formulation of new legal interventions. Though policy experimentation is inevitable, it has been the subject of relatively little systematic study. For proponents of evidence-based public health law, policy experimentation presents a paradox: if a legal intervention is truly innovative, there will not yet be direct evidence of its impact. Yet direct evidence from policy evaluations is never the only source of research knowledge relevant to a policy decision, even under conditions of novelty and uncertainty. And few interventions are truly new in a broad sense; in most instances, similarly designed laws have been deployed before, just not for the same specific purpose.
We use the case of youth sports concussion and Washington’s Lystedt Law as a case study of how even new legal strategies dealing with new problems can be built on evidence. We show how evidence about the problem lawmakers are addressing, combined with widely-used analytic tools like the Haddon Matrix and an understanding of the generic mechanisms through which law influences behavior and outcomes, can bring existing research knowledge into the crafting of even very innovative legal interventions for newly perceived problems. While we don’t expect the policy sausage factory to suddenly start looking like a research lab, there’s no question that legislators typically care about getting policy right and want evidence. The point of our paper is to get the research world to think about ways we can help even when no one has yet studied the specific law at issue.
- Ryan Abbott & Ian Ayres, Evidence and Extrapolation: Mechanisms for Regulating Off-Label Uses of Drugs and Devices, SSRN
- Joanna Shepherd, Biologic Drugs, Biosimilars, and Barriers to Entry, SSRN
- Platt R, Kass NE, McGraw D., Ethics, Regulation, and Comparative Effectiveness Research: Time for a Change. JAMA
- Henry Greely & David Kaye, A Brief of Genetics, Genomics and Forensic Science Researchers in Maryland v. King, SSRN/Jurimetrics
With the first issue of Journal of Law and Biosciences now available, the Oxford University Press blog has published an interview with I. Glenn Cohen discussing the journal’s focus and format. From the blog:
There are huge changes taking place in the world of biosciences, and whether it’s new discoveries in stem cell research, new reproductive technologies, or genetics being used to make predictions about health and behavior, there are legal ramifications for everything. Journal of Law and the Biosciences is a new journal published by Oxford University Press in association Duke University, Harvard University Law School, and Stanford University, focused on the legal implications of the scientific revolutions in the biosciences. We sat down with one of the Editors in Chief, I. Glenn Cohen, to discuss the rapidly changing field, emerging legal issues, and the new peer-reviewed and open access journal.
Read the full interview.
- Haavi Morreim, Dumping the ‘Anti-Dumping’ Law: Why EMTALA Is (Largely) Unconstitutional and Why It Matters, SSRN/Min. J L Sci Tech
- David Orentlicher, Health Care Reform and Efforts to Encourage Healthy Choices by Individuals, SSRN/N Carolina L Rev
- Kevin Outterson, New Business Models for Sustainable Antibiotics, SSRN/Centre on Global health Security Working Group Papers
- Diana Winters,The Magical Thinking of Food Labeling: The NLEA as a Failed Statute, SSRN
- Mary Crossley, Giving Meaning to ‘Meaningful Access’ in Medicaid Managed Care, SSRN/Ky LJ,
- Robert Kocher and Bryan Roberts, The Calculus of Cures, N Engl J Med
- David Hyman and William Kovacic, Why Who Does What Matters: Governmental Design, Agency Performance, the CFPB and PPACA, SSRN
- Shi-Ling Hsu, A Cost-Benefit Analysis of Sugary Drink Regulation in New York City, SSRN
Patent applicants seeking to gain global patent protection beyond their home country borders need a better comparative knowledge of key elements of the patent laws of the several countries. Professor Timo Minssen in his superb doctoral thesis directly challenges the seemingly identical statutory and treaty standards for patentability in Europe and the United States in his comparative study of the laws of Europe and the United States with respect to the treaty standard of an “inventive step.” Timo Minssen, ASSESSING THE INVENTIVENESS OF BIOPHARMACEUTICALS UNDER THE EUROPEAN AND U.S. PATENT LAWS (Goteborg, Sweden: Ineko AB 2012). Professor Minssen’s doctoral thesis represents required reading for anyone seeking to unmask the subtle differences between American and European practice (emphasis added).
- Tim Jost, Beyond Repeal — A Republican Proposal for Health Care Reform, N Eng J Med
- Larry Gostin, Legal and Ethical Responsibilities Following Brain Death,
- The McMath and Muñoz Cases, JAMA
- Erin Fuse Brown, Irrational Hospital Pricing, SSRN/Houston J H L & P
- Joseph Hall and Deven McGraw, For Telehealth To Succeed, Privacy And Security Risks Must Be Identified And Addressed, Health Affairs
- Abbe Gluck, A Legal Victory for Insurance Exchanges, N Eng J Med
- George Annas & Sherman Elias, 23andMe and the FDA, N Eng J Med
- Joseph Kvedar Molly Joel Coye and Wendy Everett, Connected Health: A Review Of Technologies And Strategies To Improve Patient Care With Telemedicine And Telehealth, Health Affairs
- Jonathan Darrow, Pharmaceutical Efficacy: The Illusory Legal Standard, SSRN/Wash & Lee L.Rev.
Laura Brennan, Ross Brownson and Tracey Orleans have come out with an important paper reviewing the evidence on policy and environmental strategies for reducing childhood obesity. Twenty-four strategies and 2000 published and gray literature documents are covered. This is a menu of more-or-less evidence backed ideas for intervention.
Sam Harper and colleagues come out with an interesting new argument for primary seat belt laws, based on a disparities analysis. Looking through the lens of education level, they (well, we, since I am one of the authors) find that, while primary enforcement has a powerful affect at every educational level, the impact is greater on people with less education. Thus, existing SES differentials in seat belt use could be reduced if all states (finally) went to primary enforcement.
Even kids like paternalism? Well, that may not be the best interpretation of this next study. Williams and McCartt surveyed New Jersey teenagers about three GDL requirements that are unique to that state: minimum licensing age of 17; application of full GDL rules to beginners younger than 21; and requiring license status decals on vehicle plates of GDL drivers. 84% liked licensing at 17, and 77% approved applying Gthe rules even to older novices. The decal policy was approved by only 23% — but a PHLR study showed it works, so I say get used to it.
Two new tobacco law studies round out the week’s harvest. Heikki et al. map the diffusion of health warning regulations since 1966, showing a big impact of the FCTC. Finally, in a paper that may start some arguments, Kevin Callison and Robert Kaestner report that adult smokers may not be as responsive to cigarette taxes as many believe. They suggest it will take increases on the order of 100% to get a further 5% reduction in smoking rates. Well, I’m okay with that.
Over on the George side of things, Peter Jacobson and Wendy Parmet have posted a thoughtful response to Larry Gostin’s Bloomberg commentary in the Hastings Center Report. They are helping us move away from a habitual application of the paternalism critique and reminding us that public health can play in the democracy sandbox pretty well.
Check out the February 7 edition of the Petrie-Flom Center’s biweekly e-newsletter for the latest on events, affiliate news and scholarship, and job and fellowship opportunities in health law policy and bioethics.
This week, PHLR launched its SciVal Experts PHLR Community website. The core of the site is publications and other information for 300 leading public health law researchers doing empirical evaluations of the impact of laws and legal practices on health. The SciVal system allows visitors to find experts by topic, to trace their institutional and individual networks, and to find the latest publications in the field.
We encourage you to visit the site and explore for yourself, but we’ll also begin periodically sharing batches of publications on this blog.
- Bill Sage and David Hyman, Let’s Make A Deal: Trading Malpractice Reform For Health Reform, Health Affairs
- Jennifer Pomeranz, A Comprehensive Strategy to Overhaul FDA Authority for Misleading Food Labels, SSRN/Am J L Med.
- Alicia Ouellette, Context Matters: Disability, the End of Life, and Why the Conversation Is Still so Difficult, SSRN/NYLS L.Rev.
- Roy Spece et al, Would Disclosures of Conflicts of Interest Change Patients’ Decisions and, If So, Would that Make Them ‘Material’ Information? SSRN
Rapid advancements in the fields of neurology and neuroscience over the past decade have enabled unprecedented progress toward the development of brain-modulating technologies and therapeutics. Central to these advancements are cross-disciplinary translational research efforts to engineer systems that can reliably deliver electrical, ultrasound, or magnetic impulses to specific deep cortical areas and neural circuits, with the ultimate goal of influencing abnormal patterns of neural activity implicated in disorders of the brain and nervous system (Famm et al. 2013). As knowledge of the brain’s dynamic synaptic networks and microcircuitry expands, it is anticipated that deep brain stimulation (DBS) technologies will begin to target neural activity with increasingly greater precision and functional efficiency (Warner-Schmidt 2013). While research in these domains carries tremendous promise for treating many neurologic and psychiatric conditions that have long been considered refractory to traditional treatments (Lozano and Lipsman2013; Nestler 2013; Warner-Schmidt 2013), they introduce a complex array of ethical, social, and legal questions.
Read the full article here.
- Stephanie Greene, After Caronia: First Amendment Concerns in Off-Label Promotion, SSRN/San Diego L. Rev.
- Bill Sage et al, How Policy Makers Can Smooth The Way For Communication-And- Resolution Programs, Health Affairs
- Tim Jost, Implementing Health Reform: Four Years Later, Health Affairs
- Nancy E. Morden et al, Choosing Wisely — The Politics and Economics of Labeling Low-Value Services, N Eng J Med
- Bill Sage, Putting Insurance Reform in the ACA’s Rear-View Mirror, SSRN/Houston L. Rev.
Following a request by the European Competition Law Review (Sweet Maxwell), I have today submitted a review of the recent publication “Pharmaceutical Innovation, Competition and Patent Law – A Trilateral Perspective”, edited by Max Planck Director Josef Drexl and Finnish scholar Nari Lee (Edward Elgar 2013, 322 p., ISBN 978 0 85793 245 7). The full contribution (6 pp.) is curently undergoing peer-review.
In summary, I conclude that the editors, who also contributed with excellent papers, have succeeded very well in the difficult task of structuring, systemizing and arranging a compilation of very interesting papers written by high profile authors. This has resulted in a very readable book providing a superb overview and up-to-date analysis of recent developments that have such a substantial impact on a significant area of law and practice. But are there any flaws?
Considering the numerous useful case law citations, as well as the wide scope of the book, it is a little unfortunate that the book does not contain a table of cases or a bibliography of material cited by the respective authors. Also it might perhaps have been beneficial to include some contributions from the pharmaceutical industry, private practice or NGOs. There is of course no doubt that all papers have been written by very competent authors and address real-world issues with much devotion to facts, details and commercial realities. But additional contributions by the industry or “field workers” would probably have enriched the numerous debates that are placed in such an extraordinarily complex environment at the interface of business realities, competition, technological innovation, and access to health care.