REGISTER NOW! Future Directions for Laboratory Animal Law in the United States

Future Directions for Laboratory Animal Law in the United States
January 26, 2018
Wasserstein Hall, Milstein East (2036)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Please join the ILAR Roundtable, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, and the Animal Law and Policy Program at Harvard Law School for a one-day meeting to discuss the future of animal law.

This event is free and open to the public, but registration is required. The workshop will also be webcast and will be accessible to all who are interested. Register now!

This event is cosponsored by the Institute for Laboratory Animal Research in the National Academies of Sciences, Engineering, and Medicine; the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School; and the Animal Law & Policy Program at Harvard Law School. 

Genomic Screening: What’s Age Got To Do With It?

By Margaret Waltz, PhD, R. Jean Cadigan, PhD, Anya E. R. Prince, JD, MPP, Debra Skinner, PhD, and Gail E. Henderson, PhD

Age is an important consideration in medical screening, but calls for population based preventive genomic screening programs do not mention an upper age limit. Should such programs employ upper age limits, as occurs in other clinical screenings, on the assumption that older individuals would not benefit clinically? To address this question, our Genetics in Medicine paper analyzed data from GeneScreen, a research study of preventive genomic screening aimed at adults. We focused on how the researchers who designed the study and 50 individuals who joined the study understood and valued age in relation to screening.

GeneScreen used a screening panel of 17 genes associated with 11 rare conditions for which treatment and/or prevention options were available, like Hereditary Breast and Ovarian Cancer, Lynch Syndrome, and Long QT Syndrome. GeneScreen researchers initially suggested an upper age limit, reflecting the assumption that older individuals were unlikely to clinically benefit from the results. One clinician worried that without an upper age limit, GeneScreen might reinforce the desire for screening among older adults and the misconception that screening “does a lot of good when you’re 80.” This was reconsidered when they discussed familial benefit. As one researcher said, participation “might not actually save the 80-year-old that we test, but [it] could save his grandchildren.” The recognition of familial benefit motivated the decision to not exclude adults based on age.

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The CVS/Aetna Deal: The Promise in Data Integration

By Wendy Netter Epstein

Earlier this month, CVS announced plans to buy Aetna— one of the nation’s largest health insurers—in a $69 billion deal.  Aetna and CVS pitched the deal to the public largely on the promise of controlling costs and improving efficiency in their operations, which they say will inhere to the benefit of consumers. The media coverage since the announcement has largely focused on these claims, and in particular, on the question of whether this vertical integration will ultimately lower health care costs for consumers—or increase them.  There are both skeptics  and optimists.  A lot will turn on the effects of integrating Aetna’s insurance with CVS’s pharmacy benefit manager services.

But CVS and Aetna also flag another potential benefit that has garnered less media attention—the promise in combining their data.  CVS CEO Larry Merlo says that “[b]y integrating data across [their] enterprise assets and through the use of predictive analytics,” consumers (and patients) will be better off.  This claim merits more attention.  There are three key ways that Merlo might be right. Continue reading

Reflecting on Behind Bars: Ethics and Human Rights in U.S. Prisons

By Gali Katznelson

Is it justifiable to chain women as they give birth? How about confining people in a way that is proven to be psychologically devastating and torturous? These are just two of the questions raised last week during the conference, Behind Bars: Ethics and Human Rights in U.S. Prisons, a conference sponsored by the Center for Bioethics at Harvard Medical School.

To kick off the two day event, Dr. Danielle Allen delivered a moving keynote in which she urged us to question two key issues: the ethics of the treatment of those behind bars, as well as the ethics of using bars. In addressing this second point, Dr. Allen tasked everyone attending the conference with a ‘homework assignment’: to read Sentencing and Prison Practice in Germany and the Netherlands: Implications for the United States, in order to encourage us to “think the unthinkable,” namely a more humane way to treat people who have committed crimes.

From this report, I learned that in Germany and the Netherlands, incarceration is seen as a last resort for individuals convicted of crimes. Alternative non-custodial sanctioning and diversion systems such as fines and task-penalties exist – and are effective. In 2010, 6% of sanctioning resulted in incarceration in Germany and in 2004, 92% of sentences were for two years or less. These incarceration systems are organized around the principles of resocialization and rehabilitation. Time spent in prison is meant to be as similar as possible to community life, and incarcerated people are encouraged to cultivate relationships within and outside of prison. In prison, individuals can wear their own clothes, structure their own days, work for pay, study, parent their children in mother-child units, vote, and return home occasionally. In these systems, respect for persons, privacy, and autonomy are strongly held values. Solitary confinement is rarely used, and cannot exceed four weeks a year in Germany, and two weeks a year in the Netherlands.

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Limited Seats Still Available, Register Now! 12/12: Sixth Annual Health Law Year in P/Review

The Sixth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2017 and what to watch out for in 2018. The discussion at this day-long event will cover hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law.

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2017’s Word Of The Year In Health Law And Bioethics: Uncertainty

This is the first post by Carmel Shachar and I. Glenn Cohen that appears on the Health Affairs Blog in a series stemming from the Sixth Annual Health Law Year in P/Review event to be held at Harvard Law School on Tuesday, December 12, 2017.

2017 was a year of tremendous uncertainty for many areas of public policy. Health care policy was no exception, most prominently with an almost successful push by Congressional Republicans to radically revise the Affordable Care Act (ACA). Medical research and bioethics also faced uncertainty, with the struggle to ethically engage with new technologies and to better understand the boundaries around self-determination. As we look over the past year and anticipate the coming one, the overarching question remains: Is it possible to run a health law and health care system given this level of flux?

Healthcare Policy in Flux

2017 saw a new presidential administration and Congress. Seeking to capitalize on the Republican control of the White House and both Houses of Congress, Congressional Republicans sought to make good on their campaign promise to “replace and repeal” the ACA. The proposed legislation would have dramatically reshaped our health care landscape, including ending Medicaid’s financial status as an entitlement program, and undercutting the health insurance Marketplaces championed by the Obama administration. Despite the fact that the ACA is not yet a decade old, this would have been a seismic shift in the way many Americans receive their health care. […]

Read the full post here.

We will be discussing these issues and more at the Sixth Annual Health Law Year in P/Review conference, held on December 12, 2017, at Harvard Law School in Cambridge, MA. If you find these issues interesting, we invite you to join us as the event is free and open to the public (registered required). For those unable to join us in Cambridge, some of our conference presenters will participate in a blog series to follow  at the Health Affairs Blog. Stay tuned!

Wendy Mariner on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

Subscribe to TWIHL here!

This week features a welcome return to the pod by Boston University health law professor Wendy Mariner. The three of us present an expanded “lighting round.” We discuss the almost-gone individual mandate, Murray-Alexander, deficit hawks targeting Medicare, the ramifications of the CVS-Aetna merger, the CMS Guidance on the contraceptive services opt-out, and a new health security settlement out of California.

Frank also mentions Centene as a potential kingpin of further health care consolidation, and his testimony before Congress on Nov. 30. TWIHL may well be the only podcast on earth to have both co-hosts before the House Energy & Commerce Committee the same year. So be sure to subscribe! And Frank welcomes AALS attendees to a panel on health law in San Diego on January 4. “From Obamacare to Trumpcare: The Future of American Healthcare” will be 10:30am – 12:00pm at the San Diego Marriott Hotel & Marina, Pacific Ballroom 22, North Tower/Level 1.

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 November. The selections feature topics ranging from the use of health care databases to support supplemental indications of approved medications, to the impact of the black triangle label on prescribing in the United Kingdom, to the role of emergency legal authority in addressing the opioid crisis. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Alpern JD, Zhang L, Stauffer WM, Kesselheim AS. Trends in Pricing and Generic Competition Within the Oral Antibiotic Drug Market in the United States. Clin Infect Dis. 2017 Nov 13;65(11):1848-1852.
  2. Fralick M, Kesselheim AS, Avorn J, Schneeweiss S. Use of Health Care Databases to Support Supplemental Indications of Approved Medications. JAMA Intern Med. 2017 Nov 20.
  3. Hakim A, Gupta R, Ross JS. High Costs of FDA Approval for Formerly Unapproved Marketed Drugs. JAMA. 2017 Nov 13. [Epub ahead of print]
  4. Horton DB, Gerhard T, Davidow A, Strom BL. Impact of the black triangle label on prescribing of new drugs in the United Kingdom: lessons for the United States at a time of deregulation. Pharmacoepidemiol Drug Saf. 2017 Nov;26(11):1307-1313.
  5. London AJ. Learning Health Systems, Clinical Equipoise, and the Ethics of Response Adaptive Randomisation. BMJ. 2017 Nov 24. [Epub ahead of print]
  6. Kim J, Ross JS, Kapczynski A. Pediatric Exclusivity and Regulatory Authority: Implications of Amgen v HHS. JAMA. 2017 Nov 8. [Epub ahead of print]
  7. Rutkow L, Vernick JS. Emergency Legal Authority and the Opioid Crisis. N Engl J Med. 2017 Nov 15. [Epub ahead of print]
  8. Sarpatwari A, Gluck AR, Curfman GD. The Supreme Court Ruling in Sandoz v Amgen: A Victory for Fellow-on Biologics. JAMA Intern Med. 2017 Nov 13. [Epub ahead of print]

TODAY, 12/4 at 5 PM: Health Law Workshop with Rachel Sachs

December 4, 2017 5-7 PM
Hauser Hall, Room 104
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA

Presentation: “Delinking Reimbursement”

This paper is not available for download. To request a copy in preparation for the workshop, please contact Jennifer Minnich at jminnich@law.harvard.edu.

Rachel E. Sachs is Associate Professor of Law at Washington University School of Law (St. Louis). She is a scholar of innovation policy whose work explores the interaction of intellectual property law, food and drug regulation, and health law. Her work explores problems of innovation and access, considering how law helps or hinders these problems. Professor Sachs’ scholarship has or will have appeared in journals that include the Harvard Journal of Law & Technology, the University of California-Davis Law Review, the Yale Journal of Law & Technology, and the peer-reviewed Journal of Law and the Biosciences. Prior to joining the faculty, Professor Sachs was an Academic Fellow at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics and a Lecturer in Law at Harvard Law School. She also clerked for the Hon. Richard A. Posner of the U.S. Court of Appeals for the Seventh Circuit. She received her JD magna cum laude from Harvard Law School and a Master of Public Health from the Harvard School of Public Health. She received her AB in Bioethics from Princeton University.

The Health Service Safety Investigations Body (HSSIB):The New Kid On The Patient Safety Block

By John Tingle

The Department of Health and the government in England have published a draft Bill for discussion which will create a Health Service Safety Investigations Body (HSSIB) with powers enshrined in law. The HSSIB replaces the current Healthcare Safety Investigation Branch (HSIB) which operates under the umbrella of NHS Improvement and came into operation in April 2017. Unlike the HSIB, the new HSSIB will be independent of the NHS, and have its own statutory power base. The HSSIB will not be responsible for investigating all serious patient safety incidents in the NHS and existing frameworks will remain.

Eight fact sheets have been published by the Department of Health to accompany the draft Bill which explain its purpose and rationale and how everything will work. It is expected that the HSSIB will investigate up to 30 serious patient safety issues a year and will have an annual budget of £3.8 Million.

It will be important for the HSSIB to manage public and NHS expectations of what it can actually achieve given its small budget, staffing and the number of investigations that it intends to carry out. There are around 24,000 serious patient safety incidents a year in the NHS. The small-scale operation of the HSSIB can be justified as it will act as an exemplar of good investigative practice and will cascade down standards into the NHS.

The Bill Continue reading

Reflecting on Dementia and Democracy: America’s Aging Judges and Politicians

By Gali Katznelson

This month, the Petrie-Flom Center collaborated with the Center for Law, Brain & Behavior  to host a panel entitled Dementia and Democracy: America’s Aging Judges and Politicians.” The panelists, Bruce Price, MD, Francis X. Shen, JD, PhD, and Rebecca Brendel, JD, MD, elucidated the problems, as well as potential solutions, to the challenges of America’s judiciary and elected politicians getting older. Reconciling dementia with democracy is a pressing matter. As Dr. Price explained, age is the single largest risk factor for dementia, a risk that doubles every five years after the age of 65, and America is a country with five of the nine Supreme Court Justices over the age of 67, a 71-year-old president, a 75-year-old Senate Majority Leader, and a 77-year-old House Minority Leader.

In his talk “Dementia in Judges and Elected Officials: Challenges and Solutions,” Dr. Shen defined the complex problem. While most other jobs are not retaining workers into old age, many judges and elected officials continue to serve well into their 80s. To complicate matters further, without widespread regulations or metrics to identify how dementia impedes one’s work, the media assumes the position of speculating the cognitive statuses and fates of judges and elected officials. Dr. Shen’s key point was, “Surely we can do better than speculation.”

Dr. Shen proposed several solutions to address dementia in elected officials and judges. Currently, we leave the open market and colleagues to regulate individuals, which remains a valid approach as we consider other options. Another default position is to diagnose based on publicly available data, a solution that introduces the specific ethical concerns that Dr. Brendel addressed in her talk (discussed below). There are, however, novel solutions. We could consider requiring cognitive testing and disclosure (which could be overseen by an internal review board), or we could simply impose an age limit for service. For judges, if such an age limit were imposed, we could create a rebuttable presumption in which a judge can continue to serve by completing an evaluation. Alternatively, perhaps judges can be limited to adjudicating specific cases based on their cognitive status.

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REGISTER NOW (12/12)! Sixth Annual Health Law Year in P/Review

The Sixth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2017 and what to watch out for in 2018. The discussion at this day-long event will cover hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law.

Continue reading

REGISTER NOW! Behind Bars: Ethics and Human Rights in U.S. Prisons

Behind Bars: Ethics and Human Rights in U.S. Prisons
November 30 – December 1, 2017
Harvard Medical School campus
Longwood Medical Area, Boston, MA

The United States leads the world in incarceration. The “War on Drugs” and prioritizing punishment over rehabilitation has led to mass imprisonment, mainly of the nation’s most vulnerable populations: people of color, the economically disadvantaged and undereducated, and those suffering from mental illness. Although these social disparities are striking, the health discrepancies are even more pronounced. What can be done to address this health and human rights crisis?

This conference will examine various aspects of human rights and health issues in our prisons. In collaboration with educators, health professionals, and those involved in the criminal justice system—including former inmates, advocates, and law enforcement—the conference will clarify the issues, explore possible policy and educational responses, and establish avenues for action.

Registration for the conference is required. To learn more and to register, please visit the HMS Center for Bioethics website.

This event is cosponsored by the Center for Bioethics at Harvard Medical School, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, and the Human Rights Program at Harvard Law School.

TODAY, 11/20 at 5 PM: Health Law Workshop with Thaddeus Pope

November 20, 2017 5-7 PM
Hauser Hall, Room 104
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA

“From Informed Consent to Shared Decision Making: How Patient Decision Aids Can Improve Patient Safety and Reduce Medical Liability Risk.”  Download the presentation here.

Thaddeus Mason Pope is Professor of Law and Director of the Health Law Institute at the Mitchell Hamline School of Law. Pope joined Hamline University School of Law in January 2012 after serving as associate professor of law at Widener University School of Law. There, his research focused on medical futility, internal dispute resolution, tort law, public health law, and normative jurisprudence. He authors a blog on medical futility, reporting and discussing legislative, judicial, regulatory, medical, and other developments concerning end-of-life medical treatment.

Pope also taught at Albany Medical College and the University of Memphis. Prior to joining academia, he practiced at Arnold & Porter and clerked on the U.S. Court of Appeals for the Seventh Circuit. Pope earned a JD and PhD in philosophy and bioethics from Georgetown University.

The NHS in England: Running to Stand Still?

By John Tingle

The Health and Social Care Regulator of the NHS in England, the Care Quality Commission (CQC) has published its latest annual report on the state of health and adult social care in England 2016/17.When reading the report ,the reader is left wondering whether the NHS as currently established can cope adequately with current future health and social care demands. The NHS turns seventy years of age next year and there is much to celebrate but there is also a lot of increasing concern about NHS efficiency, sustainability, safety and quality. The number of people aged 65 is projected to increase in all regions of England by an average of 20 % between mid-2014-and mid-2024.People are also increasingly presenting with complex, chronic or multiple conditions. The total number of people with Dementia is projected to reach one million by 2027.We are also living longer. Life expectancy at birth, 2013-2015 is 79 years for men and 83 for women. All these factors test the model of NHS care that we have and its long-term sustainability.

Like the previous year’s annual report,this year’s warns that the health and care system is operating at full stretch and that care quality in some areas is deteriorating. The situation can only get worse unless more resources are made available or new ways of the NHS operating are devised. The NHS faces an infinite public demand for its finite resources. Continue reading

The Illusion of Choice in Health Care Consumerism

By Aobo Dong

The rhetoric of “choice” has been pervasive in U.S. health care reforms and the consumerist health care culture for a long time. The idea is that giving patients more choices over doctors and insurance plans would increase competition in the industry and consequently improve the quality of health care patients receive. However, Allison Hoffman made a convincing case debunking this seemingly intuitive idea in this week’s HLS health law workshop. She argued that reform efforts aimed at increasing consumer choice often fail to empower patients to make better health care choices, and instead, create a wasteful market bureaucracy that is anathema to free market ideals. Her argument reminds me of one of my earlier blog posts on U.S. drug prices, where I compared insurance companies to the Central Planner in a socialist economy. Indeed, there are ironically many institutions and features in the so-called market-driven U.S. health care system that resemble authoritarian and technocratic practices that are directly against the principles of a laissez-faire health care economy.

I will expand Professor Hoffman’s argument by making a few additional points. First, her presentation discusses a number of revealing ways in which the market-based competition creates a false sense of choice in health care. Even Obamacare, which is supposed to offer patients more choices in the Exchange, fails to transcend the falsity of consumer choice. Most patients do not make the best available choice, even when they’re “nudged” by experts in the decision-making process. I’d like to also point out that even if consumers are capable of making the best choice for themselves, whether by thinking with perfect rationality or by accepting “expert opinions,” the choice they ultimately make could still be suboptimal or even disastrous. To understand why this might be the case, it is important to realize that the target population for Obamacare is the minority of people who do not have adequate employer-sponsored plans. Thus, many people enrolled in Obamacare may not have stable jobs and income levels. Nonetheless, the mechanism that determines how much premium for which one qualifies is predicated on an estimation of that individual’s projected annul earnings – a number that is hard to know in advance for those without stable income levels. Hence, a person who made the “right choice” by selecting a silver plan with only $100 monthly premium after receiving a $900 subsidy to cover a $1,000 plan at the beginning of a year may find herself owing the federal government thousands of dollars at the end of the tax year, if she happens to end up with a much higher income level. Had she known the future outcome, she would have chosen a less expensive plan to begin with, but either choice would be a gamble for her. This arbitrariness must be attended to in future health reforms. Continue reading

Leo Beletsky on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

Subscribe to TWIHL here!

This week features another return visit from Leo Beletsky, our friend and Northeastern University School of Law professor. Leo is a fearless critic of misguided approaches to the opioid crisis. His take is far more nuanced, using a public health frame to understand the crisis and employing evidence-based analysis to determine appropriate responses. Our wide-ranging conversation included analysis of attempts to combat crisis though law enforcement and interdiction, the inapplicability of the “vector” epidemic frame to opioids, and primary, secondary, and tertiary public health interventions.

We briefly mentioned Frank’s talk in Berlin at the Friedrich Ebert Stiftung (the think tank of Germany’s Social Democratic Party) discussing the interaction of black hat search engine optimization and addiction rehab referral.

Our lightning round discussed the latest legislative attacks on the ACA (this time through a potential individual mandate repeal), as well as some additional health policy issues.

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 Mexico City Rule and Maternal Death

By Clíodhna Ní Chéileachair

The ‘Mexico City Rule’ is a Reagan-era regulation which bars US funding to worldwide NGOs which provide counselling relating to abortion, or referrals for abortion services, or which advocate for the expansion of abortion access. The regulation is a sticking point for the two-party reality of US politics, and has been rescinded by every Democratic president since Reagan, and reinstated by each Republican president. Trump is no exception, and his administration’s approach to the policy has been exceedingly expansionist; where the policy traditionally only applied to aid tied to family planning projects, the policy now extends to all international health care aid provided by the US government, amounting to almost $9 billion every year, and covering US aid policies in the areas of family planning and reproductive health, infectious diseases, TB treatment, children’s health, nutrition, HIV/AIDS prevention, water and sanitation programs, and tropical diseases.

The effect of the policy extends past the years in which it is actively in place. Population Action International reports on a reluctance on the part of US governmental officials and non-governmental partners to enter into agreements with organizations that may be ineligible for funding in the future based on the putative reinstatement of the policy, in effect operationalizing the policy beyond the times in which it is in active effect. Beyond the expanded remit given to the policy by the Trump administration, and the temporal expansion based on likely reinstatement, the wording of the policy itself goes some way to expanding the scope of the policy beyond what might be necessary in a vacuum. The structural effect of the policy is to prevent the funding of abortion access with US aid money (an outcome which is illegal regardless through the Helms Amendment) and abortion advocacy. The policy contemplates a neat categorization of organizations such that it is possible to carve out the aspects of a healthcare organization that deal with abortion care as an aspect of reproductive health and justice. Continue reading

What does the Orphan Drug Tax Credit tell us about the Costs of Clinical Trials?

By James Love

Summary:

  • The number of patients enrolled in the trials used to support the registration of novel orphan product are significantly smaller that non-orphan products.  One measure of this is the difference in the enrollment of trials cited in the FDA drug trials snapshots.
  • Since 2015, the average number of trials cited in the FDA trials snapshots for novel drugs were 439 for orphan products, and 2,736 for non-orphans.
  • Data from the Orphan Drug Tax Credit provides insights into the costs of drug development, or more specially, the costs of the clinical trials used to support an FDA approval.
  • From 2010 to 2016, the average qualifying trial costs claimed for the orphan drug credit was $86 million to $102 million, per FDA approved orphan indication (assuming 2 to 3 year average years of lag between the credit claimed and the approval date).  Companies were able to take a credit of $43 to $51 million, on average, for each FDA approval.
  • The $86 to $102 million in pre-credit outlays is far lower than the average of $965 million on trial costs for a new drug approval, estimated by DiMasi and others in 2016.  Some of the differences are explained by the smaller trials for orphan drugs and other differences in methodologies, although both figures include the costs of failed trials and exclude pre-clinical or cost of capital costs.
  • In 2013, the last year for which we have actual rather than projected data on the credit (from the IRS Statistics of Income), the total amount of the credit from all 132 corporate tax returns that claimed the credit was just over $1 billion, nearly the same amount as the DiMasi estimate of $965 million for a single drug. But in 2013, the FDA granted 265 orphan designations and approved 33 orphan indications, including 8 novel products which were approved for an orphan drug lead indication.
  • The data from the orphan drug tax credit illustrates the large gap between the known facts about the costs for R&D for orphan drug development, and the astronomically larger R&D costs claimed by DiMasi (and frequently quoted by other researchers, policy makers and journalists) as averages that should guide policy making.
  • These data underline the need for greater transparency of R&D costs, and more sophistication and realism by policy makers regarding the costs of research and development for drugs qualifying as orphan products.
  • The data from the orphan drug tax credit also provides additional perspective on the estimates of drug development costs provided by Vinay Prasad and Sham Mailankody in their 2017 JAMA paper.

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Save The Date! 2/22/18: The Jaharis Symposium on Health Law and Intellectual Property

On February 22, 2018, join DePaul University, located in downtown Chicago, for The Jaharis Symposium on Health Law and Intellectual Property: Technological and Emergency Responses to Pandemic Diseases.

Hosted by DePaul University’s Mary and Michael Jaharis Health Law Institute and the Center for Intellectual Property Law and Information Technology (CIPLIT®), this one day conference will focus on “best practices” in response to emerging pandemic diseases.

Connect with keynote speakers Lawrence Gostin–University Professor and Faculty Director, O’Neill Institute for National and Global Health Law, Georgetown University– and Richard Wilder–Associate General Counsel, Global Health Program, Bill and Melinda Gates Foundation.  They will be joined by other esteemed panelists during this timely and important discussion.

@DepaulHealthLaw