Evolving Industry Structures in Biosimilar Development

By Rachel Sachs

Yesterday, I had the privilege to moderate a fantastic event here at the Petrie-Flom Center on Assessing the Viability of FDA’s Biosimilars Pathway.  Bringing together expert panelists from legal practice (Donald R. Ware, Partner, Foley Hoag LLP), industry (Konstantinos Andrikopoulos, Lead IP Counsel, Manufacturing, Biogen, Inc.), and academia (W. Nicholson Price II, Assistant Professor of Law, University of New Hampshire School of Law), the event explored different aspects of the biosimilars issue, considering the guidances issued (and still to be issued) by the FDA, the role of the “patent dance” in biosimilar litigation, and whether Europe’s experience with biosimilars has helpful lessons for our own situation.  For those who weren’t able to make it, video of the event will be posted on the Petrie-Flom Center’s website soon.

But I wanted to write here about one of the very last questions we explored during the panel, because its implications are more far-reaching than we had the time to consider.  The situation is as follows:  In the decades after the Hatch-Waxman Act created a generic pathway for small-molecule drugs, companies typically specialized in developing either innovator or generic drugs, but not both.  And although generic drug companies had great capacity for innovating in manufacturing, they were not research companies in the way that we think about innovator companies.  The situation has changed somewhat over the years, as generic companies began to invest in innovative products, and as innovator companies put out authorized generics, but in general this broad division within industry has persisted.

In the biologic context, by contrast, the biosimilar applications being filed with the FDA are more typically being filed by innovator companies themselves or by subsidiaries thereof.  For instance, the only biologic approved in the United States thus far is marketed by Sandoz, which is part of the innovator company Novartis.  Instead of a situation in which innovators battle generic companies for access to the market, now innovator companies are battling themselves.  There are a host of reasons for this development, most notably including the complex manufacturing processes involved in the biologics space and the need for the development of expertise there.

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Women, Girls, and Mass Incarceration: A Hidden Problem

Goodwin-Headshot11By Michele Goodwin

Mass incarceration’s invisible casualties are women and children.  Too often, they are the forgotten in a tragic American tale that distinguishes the United States from all peer nations.  Simply put, the U.S. incarcerates more of its population than anywhere else in the world–and by staggering contrast.  While the U.S. locks away over 700 men and women for every 100,000, here are comparable figures from our peer nations:  England (153 in 100,000), France (96 in 100,000), Germany (85 in 100,000), Italy (111 in 100,000), and Spain (159, in 100,000).  The U.S. accounts for less than 5% of the globes population, yet locks away nearly 25%.  Sadly, this has grave social, medical, psychological, and economic consequences.

Congressional Briefing on Women, Girls, and Mass Incarceration

In a recent essay, published in the Texas Law Review, I explained that, the population of women in prison grew by 832% in the period between 1977-2007—nearly twice the rate as men during that same period. More conservative estimates suggest that the rate of incarceration of women grew by over 750% during the past three decades. This staggering increase now results in more than one million incarcerated in prison, jail, or tethered to the criminal justice system as a parolee or probationer in the U.S. The Bureau of Justice Statistics underscores the problem, explaining in a “Special Report” that “[s]ince 1991, the number of children with a mother in prison has more than doubled, up 131%,” while “[t]he number of children with a father in prison has grown [only] by 77%.” Read More

Humanizing Pain: Advocacy, Policy and Law on Abortion, Execution and Juvenile Life Without Parole

By Robert Kinscherff

I recently attended a presentation on Fetal Pain: An Update on the Science and Legal Implications, jointly sponsored by the Center for Law, Brain and Behavior (Massachusetts General Hospital) and the Petrie-Flom Center (Harvard Law School).  Presenters were Amanda Pustilnik, JD (University of Maryland School of Law) and Maureen Strafford, MD (Tufts University School of Medicine). Video of the event is available on the website, and I encourage everyone to watch the full discussion for themselves.

Doctor Strafford delivered a masterful overview of the trajectory of scientific perspective and research about children and pain.  Over the course of her career, the medical perspective has transformed from “children do not feel pain” to “children do not remember pain” to inquiry into “when and how children feel pain.” Strafford described the medical complexities of understanding the physical and subjective aspects of pain as well as the impossibility of confidently “pinpointing” the exact point in fetal development when a neonate experiences pain.

Professor Pustilnik gave an equally compelling review of law and legal language regarding abortion, particularly law that specifically references fetal pain as a reason for limiting abortion.   This served to frame a conversation about pain and suffering in the law and the ways in which law reflects normative considerations and provides rhetoric (viewed respectively by partisans as “compelling” or “inflammatory”) to political discourse. In this case, discourse about fetal pain both attracts attention and is intended to facilitate empathy for the neonate. Read More

Update: Another Wave of ICD Settlements

By Zack Buck

There has been an update to a story I recently blogged about here.

As announced by the Department of Justice (DOJ) on Wednesday, another 51 hospitals have settled allegations that the hospitals placed implantable cardioverter defibrillators (ICDs) in the chests of patients without complying with Medicare’s mandatory waiting periods.  These 51 settlements amount to $23 million, meaning that the DOJ’s ICD review has now has resulted in settlements with more than 500 hospitals totaling more than $280 million.

According to the DOJ, this is the final stage of the investigation, concluding an initiative that has highlighted the tension that exists between fraud enforcement, medical necessity, and reimbursement standards (recent articles here, here, and here).

Monday, 2/22, Health Law Workshop with Tom Shakespeare

HLS Health Law Workshop: Tom Shakespeare

February 22, 2016 5:00 PM
Hauser Hall 102
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA 02138

Download the Papers:
“Disability and social rights: Family and intimate relations”
“Nasty, Brutish, and Short? On the Predicament of Disability and Embodiment”

Tom Shakespeare is Senior Lecturer at Norwich Medical School, the University of East Anglia. From his website:

My primary research interests are in disability studies, medical sociology, and in social and ethical aspects of genetics. I have had a long involvement with the disabled people’s movement in UK and internationally. In the context of disability arts, I have also been active in arts and culture, and was a member of Arts Council England from 2003-2008.  While at Newcastle University, I developed an interest in science communication and public engagement, and helped develop the café scientifique movement in UK and across the world, as well as promoting sci-art projects.  During my five years at WHO, I helped produce and launch key reports such as the World Report on Disability (WHO 2011) and International Perspectives on Spinal Cord Injury (WHO 2013), and was responsible for the UN statement on forced, coerced and otherwise involuntary sterilization (WHO 2014).  This grew my interest in disability and international development.

I did my PhD at Cambridge University and then worked at the Universities of Sunderland, Leeds and Newcastle, before spending five years working at the World Health Organization in Geneva.  In February 2013, I started my current post at Norwich Medical School.  I continue to consult for WHO, World Bank and other UN agencies.

1993-1996             Lecturer, University of Sunderland

1996-1999             Research Fellow, University of Leeds

1999-2008             Research Fellow, University of Newcastle, where I co-founded and developed the Policy, Ethics and Life Sciences Research Institute.

2008-2013             Technical officer, Department of Violence and Injury Prevention and Disability, World Health Organization, Geneva.

For more information, visit his website.