Health Law Policy - Bill of Health

New Resource: BPCIA Legislative History Documents

July 8, 2016July 8, 2016 The Petrie-Flom Center Staff 1 Comment

The Petrie-Flom Center is pleased to announce the availability of a new resource on its website: the legislative history of the Biologics Price Competition and Innovation Act (BPCIA). The BPCIA, passed as part of the Affordable Care Act (ACA), created a pathway for the approval of biosimilar products and awarded innovator biologic companies twelve years of exclusivity for their products. Modeled after the Hatch-Waxman Act of 1984, which established our system of generic small-molecule drug approvals while simultaneously creating a five-year period of exclusivity for new drugs, consideration of the BPCIA’s history is often lost in the discussion over the ACA’s history as a whole. This resource selects only those documents relating to the BPCIA and may thus prove particularly useful for scholars of FDA law.

This new resource comes at an opportune time, as the courts and Congress have both turned their focus to the provisions of the BPCIA. In 2015, the Federal Circuit issued a divided opinion interpreting the BPCIA’s instructions to biosimilar and innovator drug sponsors, and that opinion has now been appealed to the Supreme Court. Just last month, the Justices called for the views of the Solicitor General on this question, a step which may significantly increase the likelihood of an eventual cert grant. At the same time, several members of Congress have introduced a bill that would decrease the BPCIA’s grant of exclusivity from twelve years to seven years, bringing it more in line with the five-year period in the Hatch-Waxman Act or seven-year period in the Orphan Drug Act. The twelve-year period of exclusivity may have been the most contentious aspect of the BPCIA as passed, with even the FTC arguing strongly against such a lengthy period at the time.

Members of the public may also be interested in an article written by Professor Erika Lietzan and colleagues providing an excellent analysis of the BPCIA’s legislative history.

National Academies Report Recommends Withdrawing the NPRM and Calls for a New Belmont Report

July 8, 2016July 8, 2016 The Petrie-Flom Center Staff Leave a comment

[Crossposted from Ampersand – The PRIM&R Blog]

By Elisa A. Hurley

On June 29, the National Academies of Science, Medicine, and Engineering released Part 2 of their report, Optimizing the Nation’s Investment in Academic Research: A New Regulatory Framework for the 21^st Century. The report, written by the Committee on Federal Research Regulations and Reporting Requirements in response to a Congressional request, examines the impact of regulations and policies governing federally funded academic research in the United States. Part 1, released in September 2015, concluded that the continued expansion of federal regulations is “diminishing the effectiveness of the U.S. research enterprise, and lowering the return on federal investment in basic and applied research by diverting investigators’ time and institutional resources away from research and toward administrative and compliance matters” (xii). It made specific recommendations to reduce regulatory burden, and also recommended the creation of a “public-private Research Policy Board to streamline research policies.”

Part 2 concludes the analysis of regulations governing federally funded research and includes, in Chapter 9, a critical examination of the ethical, legal, and regulatory framework for human subjects research. The chapter begins by acknowledging that the research landscape has changed dramatically since the publication nearly 40 years ago of the Belmont Report, which established the three basic principles that provide the ethical foundation for the conduct of human subjects research in the United States. Changes in research methodologies and technologies, including comparative effectiveness research, research on de-identified biospecimens, observational studies of large datasets, cluster randomized trials, and research in emergency settings—as well as longstanding questions about the applicability to social and behavioral research of rules written for the biomedical research context—raise challenging questions about how to apply and balance the Belmont principles of respect for persons, beneficence, and justice across much of today’s research enterprise. Read More

Mehrsa Baradaran on ‘The Week in Health Law’ Podcast

July 7, 2016July 7, 2016 Nicolas P. Terry Leave a comment

By Nicolas Terry and Frank Pasquale

Listen here!

Our guest this week is Mehrsa Baradaran, J. Alton Hosch Associate Professor of Law at the University of Georgia. Author of the acclaimed book How the Other Half Banks, Baradaran described the increasingly difficult financial landscape for poorer Americans. We discussed the impact of inequality and financial exclusion on many aspects of health care finance, including providers’ collections policies, hospital-as-lender models, and high-deductible health plans. Baradaran offers many important insights on how new financial realities affect both monetary flows and consumer protection in health care.

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 iTunes, listen at Stitcher Radio, Tunein and 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 Reproductive Rights Case the Supreme Court Decided Not to Decide

June 29, 2016October 23, 2018 Dov Fox Leave a comment

By Dov Fox

The landmark abortion decision in Whole Woman’s Health v. Hellerstedt eclipsed quieter reproductive rights news out of the Supreme Court at the end of its term. It involves a couple’s claim that the Tennessee Supreme Court violated their equal protection rights by refusing to recognize “disruption of family planning as either an independent cause of action or element of damages.” You won’t have heard about this case. It wasn’t a merits judgment, but a decision not to decide. The Court’s denial of certiorari in Rye v. Women’s Care Center of Memphis has gone all but unremarked. It shouldn’t. This post lays out the arguments and why the Court (most likely) declined to hear it on appeal (without explaining its decision, as standard for cert denials). My updated article out in next year’s Columbia Law Review elaborates on the significance of professional wrongdoing that imposes, deprives, and confounds procreation in the face of people’s best efforts to plan a family.

The dispute arose during Michelle Rye’s third pregnancy. Rye has Rh negative blood, meaning that she produces antibodies that attack the blood cells of a Rh-positive fetus, potentially leading to serious harm in a born child. Doctors nowadays easily prevent this Rh-sensitization by injecting the pregnant woman with a compound called RhoGAM. But Rye’s doctor didn’t give her that injection. Now the couple couldn’t have more children of their own without risking serious health problems. Their Catholic faith took fetal testing and abortion off the table. They couldn’t even use birth control to prevent a risky pregnancy. Rye and her husband sued the doctor (who admitted negligence) for disrupting their family plans. Tennessee courts, all the way up to the state’s Supreme Court, rejected their claim. The courts held that the couple had not suffered the kind of injury that would support a legal cause of action. The Ryes’ petition to the U.S Supreme Court argued that the state Court’s refusal to recognize their claim denied them equal protection under the law. Read More

Whole Woman’s Health – Some preliminary thoughts on benefits, purposes, and fetal status

June 29, 2016June 29, 2016 jwill 3 Comments

By Jonathan Will

The Supreme Court’s decision in Whole Woman’s Health is sure to be dissected in the coming days, weeks, and months. In the meantime, I wanted to quickly reengage the discussion about the status of the “purpose prong” of Casey and what, if anything, Whole Woman’s Health tells us about it. While Justice Breyer’s analysis in the majority opinion does not seem to be couched expressly in terms of Casey’s purpose prong, the majority’s willingness to assess the applicable laws’ benefits may ultimately be purpose dressed in different clothing. If there is not sufficient evidence of a law’s benefit, there could be a problem.

As a quick refresher, recall that Casey prohibits laws that have either the purpose or effect of placing a substantial obstacle in the path of a woman seeking an abortion of a nonviable fetus. While most folks can readily associate Casey’s “undue burden” test in terms of abortion restrictions that have the effect of placing obstacles, Priscilla Smith and Caitlin Borgmann, have written about courts seemingly ignoring Casey’s other mandate that laws should not have the purpose of even trying to place such obstacles (regardless of whether they succeed in creating that effect). This avoidance of the purpose prong coupled with great deference to the asserted justifications of the legislature (without the kind of benefits inquiry seen in Whole Woman’s Health) has historically led to many TRAP (targeted regulation of abortion provider) laws being upheld.

The AMA Should Forget the Dickey Amendment — For Now

June 28, 2016June 28, 2016 sthomas Leave a comment

By Shailin Thomas

gun Recently, the American Medical Association (“AMA”) passed an emergency resolution at its annual conference declaring gun violence a public health crisis and calling for both restrictions on access to firearms and increased research into gun-related violence. In its announcement, the AMA noted that it plans to “actively lobby Congress to overturn legislation that for 20 years has prohibited the Centers for Disease Control and Prevention (CDC) from researching gun violence.”

The AMA’s decision to publicly take a strong stance on gun violence could have a substantive impact on the national conversation. The group represents one of the most powerful voices in health care policy. According to the Sunlight Foundation, the AMA is a “political powerhouse,” raising $1.3 million through its PAC during the 2014 election cycle and spending almost $22 million on lobbying in 2015 alone. To put that in perspective, the National Rifle Association — the nation’s foremost gun rights organization — spent $3.6 million on lobbying that year. Admittedly, the AMA — unlike the NRA — is a multi-issue organization, and it remains to be seen whether it will throw its financial heft behind this new position, but the fact that there is a powerful new party at the table has made some hopeful that members of Congress will start to think more seriously about finding ways to reduce gun violence. Read More

Introducing our 2016 Summer Student Bloggers

June 27, 2016June 27, 2016 The Petrie-Flom Center Staff Leave a comment

The Petrie-Flom Center is pleased to welcome Kelly Dhru and Shailin Thomas to Bill of Health as our 2016 Summer Student Bloggers!

Kelly Amal Dhru is an incoming LLM student at the Harvard Law School, and a 2016-17 Fulbright-Nehru Master’s Fellow in Public Health Law and Bioethics from India. Previously, Kelly has completed her BCL (Distinction) and MPhil in Law from University College, University of Oxford, where thesis focused on the gap between rights and duties in the context of laws preventing cruelty to animals. Kelly holds a law degree from Gujarat National Law University, and has been the Research Director at Research Foundation for Governance in India, where she has been involved in drafting laws relating to public health, bioethics and human rights. Kelly has been a research assistant for Public Health Law at King’s College London, taught the Law of Tort, Jurisprudence and Bioethics at the University of Oxford, and Ethics and Philosophy at Ahmedabad University in India. She is a co-founder and storywriter for Lawtoons: a comic series on laws and rights, and been involved spreading awareness about public health and human rights through the use of street theatre.

Shailin Thomas is a second year law student in a joint MD/JD program between Harvard Law School and the New York University School of Medicine. He received a B.S. from Yale University, where he studied cognitive neuroscience — exploring the anatomy and physiology underlying social phenomena. His interests lie at the intersection of clinical medicine and the legal forces that shape it. Prior to law school, Shailin worked on both the administrative and clinical sides of health care, and as a research associate at the Berkman Center for Internet & Society. He is currently an affiliate of the Berkman Center and Outreach Editor for the Harvard Journal of Law & Technology. A fervent proponent of privacy and freedom of expression, Shailin has also served on the Board of Directors of the American Civil Liberties Union of Connecticut.

Brexit: I woke up this morning and the world had changed

June 24, 2016June 24, 2016 John Tingle 2 Comments

By John Tingle

I voted in the referendum yesterday along with many others. The referendum turnout was 71.8%, with more than 30 million people voting. It was the highest turnout in a UK-wide vote since the 1992 general election.

My area, Broxtowe in Nottingham where I live, voted to leave the EU, 54.6%, 35754 votes, remain 45.4% 29672 votes. I live in the East Midlands, Middle England. Deep regional divisions have been laid bare by this referendum. It was notable that London largely voted to stay in the EU whereas in my region there was a notable push to leave, 58.5%.The referendum result shows British politics has, according to the Guardian newspaper, fractured beyond all recognition since the last referendum on Europe in 1975.

The issues around EU membership have been hotly debated and there was a high level of public interest in what went on. Immigration has been the dominant theme in many areas and health along with a number of other issues has also come up. At this moment we are in a post referendum, after shock stage and picking through the fallout to see what is happening and what is going to happen. People are happy, sad and anxious over the result.It was not that long after the vote was announced by the BBC that our Prime Minister David Cameron said he was going to stand down in October, that was a lot to take in so soon after the result. Looking at some of the posts on Facebook it is striking how many young people feel a sense of betrayal by the vote to leave the EU. Many seem to harbour a deep sense of resentment that they have been robbed of a future by an elder generation, it’s the baby boomers against the millennials. Read More

Deborah Lupton on ‘The Week in Health Law’ Podcast

June 23, 2016June 23, 2016 Nicolas P. Terry Leave a comment

By Nicolas Terry and Frank Pasquale

Listen here!

This week our guest is Professor Deborah Lupton, one of the world’s leading digital sociologists. Her new book, The Quantified Self, is the basis of most of our discussion–and it has fascinating lessons for health care lawyers, providers, and patients.

Deborah joined the University of Canberra in early 2014 as a Centenary Research Professor associated with the News & Media Research Centre in the Faculty of Arts & Design. Her research and teaching is multidisciplinary, incorporating sociology, media and communication and cultural studies. Deborah has previously held academic appointments at the University of Sydney, Charles Sturt University and the University of Western Sydney.

Deborah is the author of 15 books and over 150 journal articles and book chapters on topics including the social and cultural dimensions of: medicine and public health; risk; the body; parenting cultures; digital sociology; food; obesity politics; and the emotions. She is an advocate of using social media for academic research and engagement, including Twitter (@DALupton) and her blog This Sociological Life.

Those interested in further exploring the social theory of digital selfhood may be interested in Frank’s piece, The Algorithmic Self. And for some forward-thinking reflections on new technologies of digital health, check out Nic’s recent post at Health Affairs on hearing aids and regualtory arbitrage.

The Catch-22 of Bayh-Dole March-In Rights

June 20, 2016June 20, 2016 rachelsachs Leave a comment

By Rachel Sachs

Earlier today, the NIH rejected a request filed by consumer groups including Knowledge Ecology International (KEI) to exercise the government’s march-in rights on an expensive prostate cancer drug, Xtandi. Xtandi costs upwards of $129,000 per year, and KEI had asked the government to exercise its rights under the Bayh-Dole Act, which specifies a range of conditions under which the government may require a patentholder to grant licenses on reasonable terms to others to practice the patent. Specifically, the government may require such a license where “action is necessary to alleviate health or safety needs which are not reasonably satisfied,” 35 U.S.C. § 203(a)(2), or where the benefits of the invention are not being made “available to the public on reasonable terms,” 35 U.S.C. § 201(f).

For some time now, there has been debate over the question of whether high prices for pharmaceuticals are a sufficient trigger to invoke the use of march-in rights under these clauses of the statute. I don’t take a position on that question here. Instead, I want to ask whose responsibility it is to decide that question. Congress has the legal right to do so, but it seems unwilling or unable to. The agencies in question have recently declined to, even assuming they have the power to interpret the statute in that way. And so we might look to the courts. But there’s a puzzle here: it’s not clear that anyone can ask a court to decide whether high prices meet the statutory requirements unless an agency actually decides that high prices meet the statutory requirements.

Category: Health Law Policy