Introducing Blogger Nicholas Diamond

Nicholas J. Diamond, J.D., LL.M., M.B.E. is joining Bill of Health as a regular contributor.

Nick is an advisor and educator, focused on the intersection of public health, policy, and ethics. He works at an advisory firm in Washington, DC, where he helps biopharmaceutical companies, health insurers, and advocacy organizations better understand and respond to changes in the healthcare landscape. He also teaches part-time at Georgetown Law and George Washington, and holds (non-teaching) academic affiliations at the Perelman School of Medicine at the University of Pennsylvania. Continue reading

Introducing Blogger Tara Sklar

The Petrie-Flom Center is pleased to welcome Tara Sklar to Bill of Health as our newest contributor!

Tara is a Professor of Health Law and Director of the Graduate Health Sciences Programs at the University of Arizona James E. Rogers College of Law. She also holds an appointment as a Health Law Fellow in the Law and Public Health Group at the University of Melbourne, School of Population and Global Health. Prior to this she was the Founding Director of Aging Programs at the University of Melbourne, and in 2016 was awarded University of Melbourne’s Teaching Excellence in Innovation Award. She has particular interests in laws and regulations that impact population well-being, with a focus on older adults. Continue reading

Bill of Health Blog Symposium: Research Integrity and Trustworthy Science: Challenges & Solutions

We are pleased to host this symposium featuring commentary from participants in the University of Minnesota’s Consortium on Law and Values in Health, Environment & the Life Sciences event, “Research Integrity and Trustworthy Science: Challenges and Solutions.”  Below, Susan M. Wolf tees up the issues.  All posts in the series will be available here.

By Susan M. Wolf, JD (Chair, Consortium on Law and Values in Health, Environment & the Life Sciences; McKnight Presidential Professor of Law, Medicine & Public Policy; Faegre Baker Daniels Professor of Law; Professor of Medicine, University of Minnesota)

Trustworthy science is crucial to progress in scientific understanding, patient care, and product development. Yet threats to the integrity of science and to public confidence loom large. Researcher misconduct, inadequate education of new researchers, concerns over the reproducibility and rigor of scientific research, predatory journals that fail to perform thorough peer review, and oversight lapses all constitute significant threats to sound science and public trust.

A 2017 report from the National Academies on Fostering Integrity in Research carefully analyzed “detrimental research practices.” The report called for significant changes in the policies and practices of journals, research institutions, and researchers. Among the proposals was creation of a Research Integrity Advisory Board (RIAB) as an independent nonprofit. Further recommendations called for changes to allow researchers to reproduce results, including archiving datasets and code.

In March 2018, the University of Minnesota responded to the emerging research challenges and solutions by sponsoring a conference on “Research Integrity and Trustworthy Science: Challenges and Solutions.” We invited leading analysts to address the challenges for researchers, journals, and research institutions. In this blog symposium, plenary speakers from the conference examine three foundational elements of credible research:

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Challenges for Investigators—Generating Reproducible Research Results

This post is part of a series on emerging research challenges and solutions. The introduction to the series is available here, and all posts in the series are available here.

By John P.A. Ioannidis, MD, DSc, C.F. Rehnborg Chair in Disease Prevention, Professor of Medicine, of Health Research and Policy, of Biomedical Data Science, and of Statistics, and Co-Director, Meta-Research Innovation Center at Stanford (METRICS), Stanford University

Generating reproducible research results is not an easy task. As discussions about a reproducibility crisis become more common and occasionally heated, investigators may feel intimidated or even threatened, caught in the middle of the reproducibility wars. Some feel that the mounting pressure to deliver (both quantity and quality) may be threatening the joy of doing science and even the momentum to explore bold ideas. However, this is a gross misunderstanding. The effort to understand the shortcomings of reproducibility in our work and to find ways to improve our research standards is not some sort of externally imposed police auditing. It is a grassroots movement that stems from scientists themselves who want to improve their work, including its validity, relevance, and utility.

As it has been clarified before, reproducibility of results is just one of many aspects of reproducibility. It is difficult to deal with it in isolation, without also considering reproducibility of methods and reproducibility of inferences. Reproducibility of methods is usually impossible to assess, because unfortunately the triplet of software, script/code, and complete raw data is hardly ever available in a complete functional form. Lack of reproducibility of inferences leads to debates, even when the evidence seems strong and well-rounded. Reproducibility of results, when considered in the context of these other two reproducibility components, is unevenly pursued across disciplines. Some fields like genetic epidemiology have long understood the importance of routinely incorporating replication as a sine qua non in their efforts. Others still consider replication as second-class, “me too” research. Nevertheless, it can be shown (see Ioannidis, Behavioral and Brain Sciences, in press), that in most circumstances replication has at least the same value—and often more value—than original discovery. However, this leads to the question: how do we reward and incentivize investigators to follow a reproducible research path?

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Challenges for Journals—Encouraging Sound Science

This post is part of a series on emerging research challenges and solutions. The introduction to the series is available here, and all posts in the series are available here.

By Barbara A. Spellman, Professor of Law and Professor of Psychology, University of Virginia School of Law

Journals and scientists should be BFFs. But currently they are frenemies. Or, in adult-speak:

Journals play an important role in ensuring that the scientific enterprise is sound. Their most obvious function is to publish science—good science, science that has been peer-reviewed by experts and is of interest to a journal’s readership. But in fulfilling that mission, journals may provide incentives to scientists that undermine the quality of published science and distort the scientific record.

Journal policies certainly contributed to the replication crisis. As businesses, publishers (appropriately) want to make money; to do so they need people to buy, read, and cite their journals. To make that happen, editors seek articles that are novel, that confirm some new hypothesis, and that have clear results. Scientists know that editors want articles with these qualities. Accordingly, scientists may (knowingly or not) bias the scientific process to produce that type of result.

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Systems Matter: Research Environments and Institutional Integrity

This post is part of a series on emerging research challenges and solutions. The introduction to the series is available here, and all posts in the series are available here.

By CK Gunsalus, Director, National Center for Professional and Research Ethics (NCPRE), University of Illinois Urbana-Champaign

We know what it takes for institutions and scholars to produce high-quality, high-integrity research, and yet we do not always act upon that knowledge. As far back as 1988, Paul J. Friedman described both the roots of systemic shortcoming and approaches for conducting trustworthy research. Despite a clear understanding of the issues and steps that would improve our research and educational environments, the academy continues to be dogged by those same systemic issues. A recent National Academies of Sciences, Engineering and Medicine consensus study, Fostering Integrity in Research, in which I participated as a panel member, explores that same disconnect and makes recommendations. The bottom line is this: we must shift our attention and energy away from individual bad actors—though they exist and must be addressed—and toward the highly complex ecosystem within which research is conducted.

An update of an earlier appraisal published 1992, the 2017 NASEM report describes the transformation of research through advances in technology, globalization, increased interdisciplinarity, growing competition, and multiplying policy applications. It identifies six core values underlying research integrity—objectivity, openness, accountability, honesty, fairness and stewardship—and outlines best practices, including checklists, for all aspects of the research enterprise. I encourage you to read it and use these tools in your own work.

All the reports in the world won’t improve research integrity, however, if we don’t do the work in our institutions, departments, and research groups. There are many components to this effort, some of which are discussed in separate posts by my colleagues John P.A. Ioannidis and Barbara A. Spellman elsewhere in this symposium. Let’s focus here on institutional infrastructure.

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Patient Safety, Health Quality and Learning Disability

By John Tingle

Tragic stories of mental health care failings leading to injury and in some cases death have featured strongly in the English media in recent years. The reports reveal common threads such as poor resources, inadequate staffing levels, limited service availability, poor inter-agency cooperation, poor patient engagement, poor understanding of the Mental Capacity Act 2005 and so on. This care area seems to largely remain a Cinderella health care service provision, existing in the shadows, with the focus being predominantly on physical acute care. There are however now welcome and firm Government commitments to drive improvement into mental health care supported by a raft of promising initiatives.

When patient stories of learning disability and autism care failings are read from several reference sources a picture emerges. Care for people with learning disability and autism can be seen to share many of the patient safety and health quality problems that beset patients who are classified as being mentally ill: Continue reading

Count Your Calories, Says the FDA

By Nicholas J. Diamond

Fast Food emblems set on chalkboard. Hand drawn doodle style. Image via Thinkstock.

On May 7, a provision of the Affordable Care Act (ACA) relating to nutrition-labeling requirements finally went into effect, following three extensions to its compliance date by the U.S. Food and Drug Administration (FDA). In brief, under the requirements, most chain restaurants must now display calorie counts per serving on their menus. You may have already noticed that some of your favorite establishments have been ahead of the curve for awhile.

As I outline below, I broadly agree with the direction of the nutrition-labeling requirements, but highlight weaknesses and offer a way forward.

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World Trade Month: Trade’s impact on domestic drug prices

Happy World Trade Month! While health policy is often seen as something particularly domestic, trade can have an impact on health policy here at home.

Just a day before President Trump’s speech outlining the administration’s approach to rising drug costs, the Pharmaceutical Research and Manufacturers of America (PhRMA) declared May as a time to “celebrate the many American companies exporting products around the world.” However, PhRMA also warned that “Americans should not subsidize the medicine costs in other wealthy countries.”

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2018 Petrie-Flom Center Annual Conference: Beyond Disadvantage: Disability, Law, and Bioethics

2018 Petrie-Flom Center Annual Conference: Beyond Disadvantage: Disability, Law, and Bioethics
June 1, 2018 8:00 AM – 5:00 PM
Wasserstein Hall, Milstein East ABC (2036)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

“Congress acknowledged that society’s accumulated myths and fears about disability and disease are as handicapping as are the physical limitations that flow from actual impairment.” Justice William J. Brennan, Jr., School Bd. of Nassau, Fl. v. Arline, 480 U.S. 273 (1987).

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is pleased to announce plans for our 2018 annual conference, entitled: “Beyond Disadvantage: Disability, Law, and Bioethics.” This year’s conference is organized in collaboration with the Harvard Law School Project on Disability.

Conference Description

Historically and across societies people with disabilities have been stigmatized and excluded from social opportunities on a variety of culturally specific grounds. These justifications include assertions that people with disabilities are biologically defective, less than capable, costly, suffering, or fundamentally inappropriate for social inclusion. Rethinking the idea of disability so as to detach being disabled from inescapable disadvantage has been considered a key to twenty-first century reconstruction of how disablement is best understood.

Continue reading

Thad Pope on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

Subscribe to TWIHL here!

Our guest this week is Thaddeus Mason Pope, Director of the Health Law Institute and Professor of Law at Mitchell Hamline School of Law. Thad is also a Ph.D. with multiple global academic posts. This week we discuss grave and complex problems in end of life care, focusing on the tragic case of Jahi McMath. Thad recently published “Brain Death Forsaken,” and offers a wealth of insight on this and similar situations. The definition of death has complex implications for insurance, reimbursement, malpractice, and even criminal 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 Apple Podcasts, listen at Stitcher Radio Tunein, or 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.

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari, Michael S. Sinha, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant to current or potential future work in the Division.

Below are the abstracts/summaries for papers identified from the month of April. The selections feature topics ranging from experience with the FDA breakthrough drug designation pathway; to the impact of off-patent drug acquisitions on prices; to the Indian pharmaceutical patent prosecution. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Corrigan-Curay J, McKee AE, Stein P. Breakthrough-Therapy Designation—An FDA Perspective. N Engl J Med. 2018 Apr 12;378(15):1457-1458.
  2. Darrow JJ, Avorn J, Kesselheim AS. The FDA Breakthrough-Drug Designation – Four Years of Experience. N Engl J Med. 2018 Apr 12;378(15):1444-1453.
  3. Desai RJ, Sarpatwari A, Dejene S, Khan NF, Lii J, Rogers JR, Dutcher SK, Raofi S, Bohn J, Connolly J, Fischer MA, Kesselheim AS, Gagne JJ. Differences in rates of switchbacks after switching from branded to authorized generic and branded to generic drug products: cohort study. BMJ. 2018 Apr 3;361:k1180.
  4. Goldman AL, McCormick D, Haas JS, Sommers BD. Effects of the ACA’s Health Insurance Marketplaces on the Previously Uninsured: A Quasi-Experimental Analysis. Health Aff. 2018 Apr;37(4):591-599.
  5. Gupta R, Henkel A, Forman HP, Ross JS. The Impact of Off-Patent Drug Acquisitions on Prices. J Gen Intern Med. 2018 Apr 23. [Epub ahead of print]
  6. Hwang TJ, Franklin JM, Chen CT, Lauffenburger JC, Gyawali B, Kesselheim AS, Darrow JJ. Efficacy, Safety, and Regulatory Approval of Food and Drug Administration-Designated Breakthrough and Nonbreakthrough Cancer Medicines. J Clin Oncol. 2018 Apr 24. [Epub ahead of print]
  7. Sampat BN, Shadlen KC. Indian pharmaceutical patent prosecution: The changing role of Section 3(d). PLoS One. 2018 Apr 2;13(4):e0194714.

Jessica Roberts on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

Subscribe to TWIHL here!

Jessica Roberts, the Director of the Health Law and Policy Institute and a George Butler Research Professor at the University of Houston Law Center, returns to the pod. In her research, Jessica has offered compelling and innovative perspectives on a range of issues in heatlh care research, finance, privacy, and ethics.

Jessica’s book on “Health-ism,” co-authored with friend of the pod Elizabeth Weeks Leonard, is forthcoming from Cambridge University Press. We begin by discussing health discrimination before, during, and after the ACA. Then, we discuss Jessica’s take (admirably articulated in a recent Michigan Law Review book review) on the nudging at the center of healthcare’s version of behavioral economics.

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 Apple Podcasts, listen at Stitcher Radio Tunein, or 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 Notable Absence of Regulating Cannabis on FDA Commissioner Scott Gottlieb’s Radar

by Tara Sklar

At the Food and Drug Law Institute (FDLI) 2018 Annual Conference, the Commissioner of Food and Drugs, Scott Gottlieb, gave the Keynote Address to kick-off the largest turnout yet for this event of over 900 attendees. Commissioner Gottlieb’s remarks started off with how previous FDA Commissioners used this opportunity to recap the past year, but he would be different, he would lay out the strategic priorities for next year.

The room went nearly silent, as Commissioner Gottlieb steadily went through the many sectors the agency oversees, and where he believes the FDA will play a larger leadership role, including in the epidemics of addition (opioid crisis), drug costs, and greater access to generic competition. He laid out a vision that most people in the room would probably subscribe to, including “You’re public health minded, and work hard to deliver innovations that’ll advance human health. The problem is that a few bad apples, that game the system, can tarnish the entire brand of an otherwise principled industry.”[1] Close to the end of his thirty-minute speech, Commissioner Gottlieb firmly addressed the companies that produce e-cigarettes, and said, “If you target kids, then we’re going to target you.”[2]

Indeed, Commissioner Gottlieb mentioned so many FDA strategic priorities, and in such unequivocal detail for how they plan to regulate, that when the President & CEO of the FDLI, Amy Comstock Rick, thanked him and introduced the follow-up panel to discuss the issues Commissioner Gottlieb raised, she said, “We reserved one-hour in the conference to discuss Commissioner Gottlieb’s Keynote Address, but we may need five.” However, there was an area that was not brought up in Commissioner Gottlieb’s wide-ranging speech, despite its very active place in the media and scientific journals calling for the FDA to have a greater role, and more consistent guidance, and this prominent area is the future regulation of cannabis. Continue reading

REGISTER NOW! Ordeals in Health Care: Ethics and Efficient Delivery

Ordeals in Health Care: Ethics and Efficient Delivery
May 10-11, 2018 1:00 PM
Wasserstein Hall, Milstein East (2036)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA
 

Economic ordeals are interventions that deliberately make access to products or services more difficult in an effort to improve resource allocation. In this vein, making patients wait in long lines to schedule an appointment with a specialist might discourage patients with needs that could be met by less qualified personnel from taking up the specialist’s time, thus freeing up time for those with complex needs. Similarly, putting brand-name medications at the bottom of a long list of options on clinicians’ computers might encourage them to prescribe a generic brand listed closer to the top.

Recent research in development economics, behavioral economics, and health policy suggests that some economic ordeals could help target health resources to patients who are more likely to utilize these resources, without the regressive effects of co-pays and other forms of financial participation on the part of patients. However, making health care deliberately less accessible raises ethical challenges. Is it not the case that ordeals discourage utilization by patients with acute needs? Do these ordeals affect some disadvantaged populations disproportionately? And do deliberate obstacles to health resource utilization violate the human right to health?

This workshop will bring together leading scholars in economics, ethics, health policy, public health, medicine, sociology, and law to explore these questions.

This event is organized by Nir Eyal, PhD, Associate Professor of Global Health and Population, Harvard T. H. Chan School of Public Health, and Anders Herlitz, PhD, Visiting Scientist, Harvard T. H. Chan School of Public Health and Researcher, Department of Philosophy, Linguistics and Theory of Science, University of Gothenburg, Sweden.

This event is free and open to the public, but seating is limited and registration is required. Register now!

Co-sponsored by the Harvard T.H. Chan School of Public Health; the Edmond J. Safra Center for Ethics at Harvard University; the Petrie-Flom Center for Health Law, Biotechnology, and Bioethics at Harvard Law School; the Mossavar-Rahmani Center for Business and Government at the Harvard Kennedy School of Government; and the Center for Bioethics at Harvard Medical School, with support from the Oswald DeN. Cammann Fund at Harvard University.

Register for and learn more about the event here!

From bioethics to medical anthropology to humanities and back: A year in review

I thought I would take this opportunity to reflect on the past year, where I will be in the future, and how the student fellowship has impacted me. I still hope to contribute to the Bill of Health blog going forward, but as my last official post as a Petrie-Flom Student Fellow, I would be remiss if I did not express my sincere gratitude to everyone at the Petrie-Flom Center, the faculty and staff, the other student fellows, and especially my mentors: Professors I. Glenn Cohen, Carmel Shachar, and Intisar A. Rabb.

My own project took a few different turns this year. My original proposal was to explore the ways in which bioethics and biomedical issues will play a significant role in reviving the dialectic between secular scholars and religious authority. Ayman Shabana rightly argues that respect for Islamic religious norms is essential for the legitimacy of bioethical standards in the Muslim context, wherein he attributes the legitimating power of these norms—as well as their religious and spiritual underpinnings—to their moral, legal, and communal dimensions. Building off of Shabana’s work, my initial argument held that the relationship between the secular and religious worlds is important because the discourse between the two, although often presumed to be dichotomous, is not necessarily antithetical nor is it impassable. This led me back to the arguments of the venerable philosophers Alasdair MacIntyre and Charles Taylor whereby, in critiquing the concept of secularism itself along with its historical contexts, furthered my argument and helped me to clarify the significant role that religion plays vis-à-vis categorical issues such as fundamental beliefs and metaphysics. I still maintain this, and it is something I continue to work on, although I decided to take my project in another direction.

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Join us- we are hiring: Postdoctoral position in Biomedical Innovation Law with a focus on Biologics

Having a PhD and specialized in biomedical innovation law & legal/regulatory issues in biologic drug development? Interested in empirical legal research and data analysis?Then join our international research collaboration at the University of Copenhagen with core partners from i.a. the UK (University of Cambridge) and the US (Harvard Medical School, Harvard Law School (PFC) & Michigan Law School). Apply for a PostDoc position at the Center for Advanced Studies in Biomedical Innovation Law right here  .

Elder abuse is not substantiated

Philip C. Marshal is an elder justice advocate and founder of Beyond Brooke. The remarks below were prepared for Our Aging Brains: Decision-making, Fraud, and Undue Influence, part of the Project on Law and Applied Neuroscience at Harvard Law School; April 27, 2018. The complete version of Decision-making, fraud, and undue influence—illustrated through the lens of the Brooke Astor story was published April 28, 2018 in Medium.

The meaning of elder abuse remains misunderstood, even by professionals.

I know—from hard-learned experience—when I, and many others, worked to save my grandmother from abuse by my father.

In a December 2006 court decision, my grandmother’s guardianship judge authorized reimbursement of my legal fees for bringing a guardianship petition for my grandmother, stating, “Although this matter voluntarily settled before the hearing, I find the petitioner Philip Marshall was the prevailing party…”

But the judge also decided to award my father a portion of his legal fees, writing, “I make this ruling based on the conclusion of the court evaluator that the allegations in the petition regarding Mrs. Astor’s medical and dental care, and the other allegations of intentional elder abuse by the Marshalls, were not substantiated.” [italics added]

Decision—In the Matter of the Application of Philip Marshall for the appointment of a Guardian for the Person and Property for Brooke Astor, an Alleged Incapacitated Person. Judge John A. Stackhouse, Supreme Court of the State of New York. December 4, 2006 Continue reading

2018 Petrie-Flom Center Annual Conference: Beyond Disadvantage: Disability, Law, and Bioethics

2018 Petrie-Flom Center Annual Conference: Beyond Disadvantage: Disability, Law, and Bioethics
June 1, 2018 8:00 AM – 5:00 PM
Wasserstein Hall, Milstein East ABC (2036)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

“Congress acknowledged that society’s accumulated myths and fears about disability and disease are as handicapping as are the physical limitations that flow from actual impairment.” Justice William J. Brennan, Jr., School Bd. of Nassau, Fl. v. Arline, 480 U.S. 273 (1987).

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is pleased to announce plans for our 2018 annual conference, entitled: “Beyond Disadvantage: Disability, Law, and Bioethics.” This year’s conference is organized in collaboration with the Harvard Law School Project on Disability.

Conference Description

Historically and across societies people with disabilities have been stigmatized and excluded from social opportunities on a variety of culturally specific grounds. These justifications include assertions that people with disabilities are biologically defective, less than capable, costly, suffering, or fundamentally inappropriate for social inclusion. Rethinking the idea of disability so as to detach being disabled from inescapable disadvantage has been considered a key to twenty-first century reconstruction of how disablement is best understood.

Continue reading

Tertiary Patents: An Emerging Phenomenon

By Jonathan J. Darrow

Brand-name pharmaceutical manufacturers have long been known to try to protect and extend their market exclusivity periods by obtaining patents on a drug’s substance (“primary patents”) and also on its peripheral features, such as formulations or methods of manufacture (“secondary patents”). A new study describes an emerging phenomenon of “tertiary patents,” which have the potential to further delay and discourage market entry in the context of drug-device combination products.

Combination products are defined by the U.S. Food and Drug Administration (FDA) to include therapeutic products that combine a drug with a device, such as an inhaler or injector pen. These products can sometimes offer life-changing or life-sustaining treatment, as with naloxone (Narcan) for opioid overdose or epinephrine (EpiPen) for severe allergic reactions. In recent years, these and other similar products have been the subject of substantial controversy related to their prices and prolonged lack of generic competition.

To investigate the potential role of patents on the prices and exclusivity periods of drug-device combination products, two researchers at the Program On Regulation, Therapeutics, And Law (PORTAL) at Brigham and Women’s Hospital and Harvard Medical School (where I hold a faculty appointment) conducted a comprehensive evaluation of drug-device combination patents registered with the FDA. They found that patents related to drug delivery devices have tripled since the year 2000 and contribute a median of five years of additional market exclusivity to those products (subject, of course, to potential judicial or administrative patent invalidation). Furthermore, the researchers identified a subset of 31 products having only device patents (i.e., having no primary or secondary patents), and found that these patents were scheduled to expire a median of 17 years after FDA approval. Continue reading