The Once and Future Regulation of Biotechnology

By Seán Finan

whitehouse_slideOn 16th September, 2016, the White House released two documents jointly authored by the FDA, the EPA and the USDA. Together, the “Update to the Coordinated Framework for the Regulation of Biotechnology” (the “Update”) and the “National Strategy for Modernizing the Regulatory System for Biotechnology Products” (the “Strategy”) will form the basis for the federal government’s regulatory policy for biotech for the foreseeable future. So, where did these documents come from? What do they contain?

Background

Last year, the federal government asked the FDA, the EPA and the USDA to

  1. Clarify the current roles and responsibilities of the EPA, FDA, and USDA in the regulatory process;
  2. Develop a long-term strategy to ensure that the Federal regulatory system is equipped to efficiently assess the risks, if any, of the future products of biotechnology; and
  3. Commission an expert analysis of the future landscape of biotechnology products

(Source)

14 months, three public meetings and 900 responses to a Request for Information later, the two documents were released. The Update sets out to respond to the first of the above prompts and the Strategy aims to respond to the second. An answer to the third is still in the pipeline.

Aims

The underlying policy is made explicit in the first paragraph of the Strategy’s Executive Summary (p4):

The policy of the United States Government is to seek regulatory approaches that protect health and the environment while reducing regulatory burdens and avoiding unjustifiably inhibiting innovation, stigmatizing new technologies, or creating trade barriers

Apart from clarifying the current roles of the FDA, EPA and USDA and setting out the path for future developments, both documents make it clear that they aim

  • to help the public understand how the safety of biotechnology products is evaluated and
  • to help businesses navigate the current regulatory structure.

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Medical Malpractice in Pennsylvania: What is MCARE and how does it work?

By Matthew Young

Medical malpractice in Pennsylvania revolves around the MCARE statute. MCARE stands for “Medical Care Availability and Reduction of Error” — an Act passed and signed into law in 2002.

MCARE requires that participating providers and hospitals carry a minimum of $500k in coverage per occurrence or claim. (We will get back to what exactly counts as an “occurrence.”) MCARE also refers to a special fund within the State Treasury that aims to “ensure reasonable compensation for persons injured due to medical negligence.” The MCARE fund pays claims in excess of the $500k in coverage that participating health care providers and hospitals are already required to buy themselves to insure against medical professional liability actions.

How does an injured patient get compensated? Here’s how it works: first, a provider has to tender their $500k. Only after they tender does the MCARE fund offer excess coverage. The excess coverage offered is an additional $500k. So if you sue a provider and a hospital, each self-insured with $500k, you can recover $1 million from the self-insurance, and on top of that, once both the provider and hospital tender, the MCARE fund can layer on an additional $500k for the provider and an additional $500k for the hospital. $500k from the provider + $500k from MCARE for the provider + $500k from the hospital + $500k from MCARE for the hospital = $2 million recovery. Simple enough, right?

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Paul Lombardo on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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Subscribe to TWIHL here! Our guest this week is Paul A. Lombardo, Regents’ Professor and Bobby Lee Cook Professor of Law at Georgia State University. Paul has written articles and books a wide array of topics in health law, medico-legal history, and bioethics. His books include: Three Generations, No Imbeciles: Eugenics, the Supreme Court and Buck v. Bell (2008) and A Century of Eugenics in America: From the Indiana Experiment to the Human Genome Era (2011). From 2011-2016, he was  a senior advisor to the Presidential Commission for the Study of Bioethical Issues. He has also served on the Board of Directors of the ASBH. Continue reading

Bioethicist Art Caplan: Right-To-Try Laws For The Terminally Ill Are Bad Policy

A new piece by Bill of Health contributor Art Caplan in Forbes:

Nathan Nascimento thinks that right-to-try laws aimed at the terminally ill are sound public policy. He is wrong.

Mr. Nascimento’s commentary misrepresents the complexities of the drug development process and the issues surrounding granting access to experimental medicines before they have been fully tested.

The overarching issue, despite his rhetoric to the contrary, is that the safety and efficacy profile of a new medicine is not sufficiently understood until after the drug has completed at least a pivotal Phase 3 clinical trial.

The underlying principle of every clinical development program is to understand, via testing first for safety usually in a small number of patients afflicted with the target condition, and, subsequently, in increasing numbers of patients, the benefits as well as the risks of new medicines. Like it or not, this is a time-consuming, expensive, but appropriate and necessary process. []

Read the full post here.

Melinda Buntin on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

twihl 5x5This week we welcome Melinda J. Beeuwkes Buntin, Chair of the Department of Health Policy at Vanderbilt University’s School of Medicine. She previously served as Deputy Assistant Director for Health at the Congressional Budget Office (CBO), and worked at the Office of the National Coordinator for Health IT. At RAND, Melinda served as deputy director of RAND Health’s Economics, Financing, and Organization Program and co-director of the Bing Center for Health Economics. Her research at RAND focused on insurance benefit design, provider payment, and the care use and needs of the elderly. For the lightning round, Nic discussed technological improvement of decisionmaking, both for consumers and doctors. Nic also covered CMS’s rejection of Ohio’s request for a new section 1115 demonstration (which would have charged “premiums, regardless of income, to the 600,000 individuals in Ohio’s new adult group, as well as hundreds of thousands of low income parents, foster care youth, and beneficiaries with breast and cervical cancer”). Frank offered a counterintuitive look at the EpiPen and the present technocrat rage to privatize the VA. During the conversation, we covered some topics in CBO modeling, including Melinda’s recent paper on changes in spending by age of beneficiary. Frank mentioned some general concerns about CBO’s modeling raised by Federal Reserve economists, the GAO, Tim Westmoreland (in 2008 and 2007), Maggie Mahar, Timothy Jost, and Bruce Vladeck. We look forward to more conversations on the nature of health cost projections!

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

Subscribe to TWIHL here!

The Federal Government Should Consider Medical Marijuana a Potential Ally in the Fight Against Opioid Addiction

By Shailin Thomas

The United States is in the midst of what many are calling an opioid epidemic. According to the American Society of Addiction Medicine, more than 1.9 million people in the U.S. have a substance use disorders involving prescription pain medications, and another 580,000 have substance abuse issues with heroin. The human costs of these rates of addiction are staggering.   Of the approximately 50,000 lethal drug overdoses that happen each year, almost 20,000 are the result of prescription opioids, and another 10,000 are the result of heroin. While prescription painkillers traditionally aren’t as dangerous as heroin, the connection between the two is well established. According to a 2013 survey, about 80% of heroin users started out abusing opioid painkillers.

Despite continued efforts at nearly every level of government, the rates of opioid addiction and overdose have continued to climb. However, researchers have identified an unlikely ally that may have quietly been slowing the rise of opioid use in certain states: medical marijuana.

A study recently released by Columbia University’s Mailman School of Public Health suggests that medical marijuana availability is linked to decreases in opioid usage. The study looked at opioid prevalence in autopsy reports from fatal car accidents over 14 years, and found that states that passed medical marijuana laws in that period saw a relative decrease in opioid prevalence compared to states that didn’t. While this study is making a splash, it’s just the most recent piece in a long line of research into the connection between medical marijuana availability and opioid use. One study published in Health Affairs in July showed that states which implemented medical marijuana laws between 2010-2013 saw a significant decrease in Medicare Part D prescriptions filled for medications for which marijuana is a possible alternative therapy — including opioids. Another study from 2014 showed a 25% decrease in deaths from prescription pain medication overdoses in states that implemented medical marijuana laws. Continue reading

Regulating the Statutory Duty of Candour

By John Tingle

Patients are very much the weaker party in the care equation. Doctors and nurses are always in a much more powerful position as they have the command of a discrete, specialised body of professional knowledge which the patient has not got and often urgently needs. To make the National Health Service (NHS) much more patient centered and to improve the quality of care we need to take account of this imbalance in the care equation which favours healthcarers. We can do this by explaining more carefully to patients about their treatment options and respecting their autonomy as individuals.

All organisations and those working in them need to be honest, open and truthful in all their dealings with patients and the public. A statutory duty of candour now exists in law in the NHS through regulations and is enforced by the Care Quality Commission (CQC), Health and Social Care Act 2008 (Regulated Activities) Regulations 2014: Regulation 20. The CQC can prosecute for a breach of parts 20(2) (a) and 20(3) of this regulation and can move directly to prosecution without first serving a Warning Notice. Additionally, CQC may also take other regulatory action.

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Sarepta: Where Do We Go From Here?

By Rachel Sachs

This morning, the FDA finally reached a decision in the closely watched case of Sarepta Therapeutics and its drug for the treatment of Duchenne Muscular Dystrophy (DMD).  The FDA granted accelerated approval to Sarepta’s drug, Exondys, on the condition that Sarepta complete a new trial demonstrating the drug’s clinical effectiveness.  As regular FDA observers already know, Exondys’ path to approval has been highly contentious.  The key clinical trial used to support approval contained just twelve patients and no placebo, and the FDA Advisory Committee voted against both full approval of the drug and accelerated approval.  The FDA’s 126-page Summary Review, released today with their approval letter, reveals the intense disagreements within the agency over Exondys’ approval.  FDA staff scientists charged with reviewing the drug recommended against approval but were overruled by Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research.  FDA Commissioner Califf deferred to her decision.

Sarepta presented the FDA with a series of bad options.  DMD is a rare, heartbreaking, and ultimately fatal genetic disease with no other real treatments, and it is clear why patients and their families would fight for access to anything that might work.  At the same time, the FDA has rarely if ever approved a drug on less evidence than that provided by Sarepta, and approving the drug might send a dangerous signal to both the public and other companies investigating rare disease drugs.  The FDA has now made its choice.  Where do we go from here?  In my view, there are at least three key issues to watch going forward. Continue reading

Monday, 9/19, HLS Health Law Workshop with Amy Sepinwall

September 19, 2016 5-7 PM
Hauser Hall, Room 104
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA

Download the Presentation: “The Challenges of Conscience in a World of Compromise”

Amy Sepinwall is Assistant Professor of Legal Studies and Business Ethics and James G. Campbell, Jr. Memorial Term Assistant Professor of Legal Studies and Business Ethics at the Wharton School at the University of Pennsylvania. Her research interests include individual and collective responsibility for corporate and financial wrongdoing, corporate constitutional rights, and gender and racial justice. Prior to joining the faculty at the Wharton School, she clerked for the Honorable Louis H. Pollak, Eastern District of Pennsylvania.

Sepinwall earned her PhD from Georgetown University and her JD from Yale Law School. She also holds MA and BA degrees from McGill University. From 2007 – 2008, she held a Charlotte Newcombe Dissertation Fellowship at the Woodrow Wilson Foundation.

Confidentiality or Public Disclosure: Trump’s Gastroenterologist and an Ethical Dilemma

By Brad Segal

“If elected, Mr. Trump, I can state unequivocally, will be the healthiest individual ever elected to the presidency,” proclaimed Dr. Harold Bornstein. The gastroenterologist’s letter, released on the candidate’s website nine months ago, stumbles from the outset with a typo (“To Whom My Concern,”), then steamrolls over the most basic descriptions of health (medical school teaches us that vital signs are, well, vital), omits information pertinent to the public discourse (why does it fail to mention the medical reason exempting Trump from the Vietnam draft?), and strangely emphases non-medicalized traits (“His physical strength and stamina are extraordinary”). Most experts agree that this medical record, if we can even call it that, is at best hyperbole. It draws grandiose conclusions without medical justification. Even Dr. Bornstein conceded, “In the rush, I think some of those words didn’t come out exactly the way they were meant.”

Just this morning the Trump campaign released a second letter from Dr. Bornstein. But this time the doctor rather humbly concludes, “In summary, Mr. Trump is in excellent physical health.”  These letters from Dr. Bornstein’s letter demonstrate a modern-day moral dilemma in providing care for a party nominee. At conflict is the physician’s professional duty to respect patient confidentiality, and his or her obligations to care for society more broadly.

First, patient-doctor confidentiality is not merely a byproduct of the law—it is a moral obligation grounded in the core tenants of the medical profession. To put it simply, if a patient comes to expect that his doctor will tell the entire community about the patient’s most embarrassing bodily defects, the patient may understandably deny his worsening symptoms of poor health at the next office visit. In the long run, erosion of trust in the medical system could endanger the public’s health–everyone is thus better off when doctors uniformly respect patient privacy. It is important to point out, however, that an informed and competent person can voluntarily waive one’s right to patient-doctor confidentiality, such as when a patient gives a physician the permission to provide updates to family members. Or when then-candidate John McCain instructed his physicians all 1,100 pages in his medical records.

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Mental Health First Aid Training in Prisons, Police Departments, and the Presidential Election

By Wendy S. Salkin

It has been widely reported and acknowledged that many incarcerated Americans live with mental illness. In 2014, the Treatment Advocacy Center and the National Sheriffs’ Association published The Treatment of Persons with Mental Illness in Prisons and Jails: A State Survey, a joint report that included the following findings:

  • In 2012, there were estimated to be 356,268 inmates with severe mental illness in prisons and jails. There were also approximately 35,000 patients with severe mental illness in state psychiatric hospitals. Thus, the number of mentally ill persons in prisons and jails was 10 times the number remaining in state hospitals.
  • In 44 of the 50 states and the District of Columbia, a prison or jail in that state holds more individuals with serious mental illness than the largest remaining state psychiatric hospital. For example, in Ohio, 10 state prisons and two county jails each hold more mentally ill inmates than does the largest remaining state hospital.

Similarly widely reported and acknowledged is that prisons often either cannot or simply do not serve the mental health treatment needs of those housed within their walls. As Ana Swanson of The Washington Post observed:

Unsurprisingly, many prisons are poorly equipped to properly deal with mental illness. Inmates with mental illnesses are more likely than other to be held in solitary confinement, and many are raped, commit suicide, or hurt themselves.

Solitary confinement is often used as a means of separating inmates living with mental illness from the rest of a prison population. As Jeffrey L. Metzner and Jamie Fellner reported in their March 2010 article, “Solitary Confinement and Mental Illness in U.S. Prisons: A Challenge for Medical Ethics”: Continue reading

J. B. Silvers on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

Subscribe to TWIHL here!
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We welcomed J. B. Silvers to the podcast this week. J. B. is the John R. Mannix Medical Mutual of Ohio Professor of Health Care Finance, and Professor of Banking and Finance, at the Weatherhead School of Management, with a joint appointment in the Case Western Reserve University School of Medicine.

We asked J. B. many questions about the state of the ACA, hospitals’ adaptation to the rapidly changing policy environment, and ongoing worries about a death spiral on the exchanges. He offered refreshing and insightful perspectives on a range of live controversies in health care finance.

J. B. has served on committees at the National Academies and several national and state commissions. Until recently, he was a board member (12 years) and treasurer of the Joint Committee on Accreditation of Healthcare Organizations (TJC/JCAHO) and a board member of SummaCare Insurance Company (14 years). For seven years Silvers was a commissioner on the Prospective Payment Assessment Commission (now MedPAC) advising Congress on Medicare payment. From 1997 to 2000, while on leave, he served as President and CEO of QualChoice Health Plan and Insurance Company. He currently is vice chair of the board at MetroHealth Medical Center.

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

Medical Malpractice Under a National Health System and the ACA

By Matthew H. H. Young

What will happen to the current medical malpractice system under a single-payer system?

To answer this question, I started by looking at the information provided by Physicians for a National Health Program, whose mission is to replace the ACA (Affordable Care Act) with single-payer. On their website under Single-Payer FAQs, it says:

What will happen to malpractice costs under national health insurance?

They will fall dramatically, for several reasons. First, about one-fourth of all malpractice awards go to pay present and future medical costs (e.g. for infants born with serious disabilities). Single payer national health insurance will eliminate the need for these awards. Second, many claims arise from a lack of communication between doctor and patient (e.g. in the Emergency Department). Miscommunication/mistakes are heightened under the present system because physicians don’t have continuity with their patients (to know their prior medical history, establish therapeutic trust, etc) and patients aren’t allowed to choose and keep the doctors and other caregivers they know and trust (due to insurance arrangements). Single payer improves quality in many ways, but in particular by facilitating long-term, continuous relationships with caregivers. For details on how single payer can improve the quality of health care, see “A Better Quality Alternative: Single Payer National Health Insurance.” For these and other reasons, malpractice costs in three nations with single payer are much lower than in the United States, and we would expect them to fall dramatically here. For details, see “Medical Liability in Three Single-Payer Countries” paper by Clara Felice and Litsa Lambkros.

Let me address the most salient part of the above argument, which states that the significant burden of malpractice recoveries composed of future medical costs will be alleviated because all individuals will be insured. Continue reading

Hospitals Should Think Before Performing Searches for Law Enforcement

In 2012, a Jane Doe suspected of transporting drugs was detained by U.S. Customs and Border Protection (CBP) agents without a warrant, and brought to University Medical Center in El Paso, Texas. Medical Center personnel — under the direction of the law enforcement agents — performed an X-ray, CT scan, and cavity search before determining that the woman was not in fact carrying any controlled substances. A few months after suffering this traumatic — and possibly illegal — event, the woman received a $5400 bill from the Medical Center for the services rendered as part of the search.

While the woman was compensated to some extent — she settled lawsuits with University Medical Center and the CBP to the tune of $1.1 million and $475,000, respectively — her story, and stories like hers, raise important questions about the ways in which hospitals should (or shouldn’t) work with law enforcement to perform invasive searches.

It’s understandable why hospitals and medical professionals are inclined to cooperate with law enforcement requests for invasive procedures and cavity searches — law-abiding citizens often don’t want to obstruct law enforcement agents from doing their jobs. But in the course of bringing suit against University Medical Center, Edgar Saldivar of the ACLU of Texas noted that the hospital and many of its personnel didn’t know where the obligation to assist the CBP stopped. Many medical professional don’t know that — according to the CBP’s own Personal Search Handbook — they are under absolutely no obligation to comply with requests by law enforcement to perform cavity searches with or without a warrant.

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Monday, 9/12, HLS Health Law Workshop with Patricia Zettler

September 12, 2016 5-7 PM
Hauser Hall, Room 104
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA

Download the Presentation: Pharmaceutical Federalism

Patricia J. Zettler is associate professor of law at Georgia State University College of Law. She has expertise in the regulation of medicine, biotechnology and biomedical research, with an emphasis on the U.S. Food and Drug Administration. Her research focuses on the interaction between state and federal regulation of medicine and science, the challenges that innovation poses for the FDA’s regulatory scheme, and the treatment use of experimental drugs and devices outside of clinical trials. Zettler’s scholarship has appeared or is forthcoming in various legal and medical journals, including the Indiana Law Journal, San Diego Law Review, Yale Journal of Health Policy Law and Ethics, Journal of Law and the Biosciences, Boston University International Law Journal, JAMA Internal Medicine, EMBO Molecular Medicine, and Academic Medicine. Zettler teaches Torts, Health Law: Quality & Access, and Food and Drug Law.

Before joining Georgia State Law in 2015, she was a fellow at the Center for Law and the Biosciences at Stanford Law School. Prior to her fellowship, she served as an associate chief counsel in the FDA’s Office of Chief Counsel, where she advised the FDA and the Department of Health and Human Services on various issues including drug safety, human subjects protection, expanded access to investigational drugs, over-the-counter drugs, dietary supplements, prescription drug advertising and promotion, incentives for developing antibiotics and advisory committees. Continue reading

REGISTER NOW (11/7): The Ethics of Early Embryo Research & the Future of the 14-Day Rule

egg cells flowing in a blue background

The Ethics of Early Embryo Research & the Future of the 14-Day Rule
November 7, 2016 3:00 – 6:00 PM
Austin Hall, North Classroom (100)
Harvard Law School, 1515 Massachusetts Ave., Cambridge, MA
 

Description

For over 35 years, the “14-Day Rule,” prohibiting in vitro experimentation on embryos beyond 14 days, has stood as an ethical line in the sand for embryo research around the world. Throughout the arc of the rule’s existence it has not been questioned, as scientists have been unable to grow embryos in vitro either up to, or beyond, 14 days; a practical limitation that served as a backstop to the ethical rule. However, in May of this year, labs in the U.S. and the U.K. were the first to report being able to sustain human embryos in vitro for up to 13 days. This development and other advances in in vitro research involving organized, embryo-like cellular structures have raised a number of questions about the rule, its genesis, application, and future scope. This conference will convene experts in bioethics, stem cell research, embryology, and law to discuss the ethical underpinnings and future scope of the rule. Questions to be discussed include:

  • What are the historical, ethical and scientific rationales for establishing the 14-Day Rule?
  • Should the 14-Day Rule be revisited in light of recent advances?
  • Should the 14-Day Rule even apply to research involving the in vitro culture of embryo-like cellular structures?

Tentative Agenda Continue reading

Corralling the Herd: California Medical Board Acts Against Anti-Vax Doc

This summer, California’s strict new childhood immunization law, barring all exemptions except those needed for medical purposes, went into effect for public and private schools, preschools, and day cares. This law was passed as a response to the highly-publicized 2014-2015 multi-state measles outbreak that originated at Disneyland, and also in response to the growing number of California communities with large clusters of families exempting their children from vaccine requirements, putting at risk community protection from vaccine-preventable illnesses.

As I’ve written about before, both here and in articles with Tony Yang, there are many different ways to structure childhood vaccination laws. While much of the attention goes to whether or not states offer parents the right to exempt their children based on religious and/or philosophical grounds — see, for example, the recent American Academy of Pediatrics report supporting mandated vaccination for school and daycare attendance —  there are many other implementation-related details in the laws that can increase or decrease the law’s efficacy at maintaining high vaccination coverage rates. For example, some states may require that exemption requests be filed annually (increases efficacy), some states require only that a form be correctly completed (decreases efficacy), some states allow for historically anti-vax practitioners, such as naturopaths, to complete medical exemption forms (decreases efficacy, and creates a new, permanent loophole for gaining exemptions), some states require that medical exemptions be reviewed and approved by a state public health officer (increases efficacy). Continue reading

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

By Ameet Sarpatwari 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, in-depth analyses, and thoughtful editorials on pharmaceutical law and policy.

Below are the papers identified from the month of August. The selections feature topics ranging from the impact of prescription drug monitoring programs and pill mill laws on high-risk opioid prescribers, to the impact of formulary drug exclusions on patient health outcomes and costs, to the origins of and possible solutions to high prescription drug prices in the United States. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Chang HY, Lyapustina T, Rutkow L, Daubresse M, Richey M, Faul M, Stuart EA, Alexander GC. Impact of prescription drug monitoring programs and pill mill laws on high-risk opioid prescribers: A comparative interrupted time series analysis. Drug Alcohol Depend. 2016;165:1-8.
  2. Chambers JD, Rane PB, Neumann PJ. The impact of formulary drug exclusion policies on patients and healthcare costs. Am J Manag Care. 2016;22(8):524-31.
  3. Doshi JA, Lim R, Li P, Young PP, Lawnicki VF, State JJ, Troxel AB, Volpp KG. A Synchronized Prescription Refill Program Improved Medication Adherence. Health Aff. 2016;35(8):1504-12.
  4. Fleischman W, Agrawal S, King M, Venkatesh AK, Krumholz HM, McKee D, Brown D, Ross JS. Association between payments from manufacturers of pharmaceuticals to physicians and regional prescribing: cross sectional ecological study. BMJ. 2016;354:i4189.
  5. Green AK, Wood WA, Basch EM. Time to Reassess the Cancer Compendia for Off-label Drug Coverage in Oncology. JAMA. 2016 Aug. [Epub ahead of print]
  6. Hey SP, Kesselheim AS. The FDA, Juno Therapeutics, and the ethical imperative of transparency. BMJ. 2016;354:i4435.
  7. Kesselheim AS, Avorn J, Sarpatwari A. The High Cost of Prescription Drugs in the United States: Origins and Prospects for Reform. JAMA. 2016;316(8):858-71.
  8. Sarpatwari A, Gagne JJ. Balancing benefits and harms: privacy protection policies. Pharmacoepidemiol Drug Saf. 2016;25(8):969-71.
  9. Wolf MS, Davis TC, Curtis LM, Bailey SC, Knox JP, Bergeron A, Abbet M, Shrank WH, Parker RM, Wood AJ. A Patient-Centered Prescription Drug Label to Promote Appropriate Medication Use and Adherence. J Gen Intern Med. 2016 Aug. [Epub ahead of print]

DUE TOMORROW, 9/9! Call for Harvard Submissions to Journal of Law & the Biosciences

image001The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School collaborates with Stanford and Duke Universities to publish the Journal of Law and the Biosciences (Oxford University Press), an online, open-access, peer-reviewed journal. JLB includes a Notes & Developments section, comprised of brief summaries and commentary on recent legislation, regulation, and case law written by graduate students at the collaborating schools. The Petrie-­Flom Center is responsible for providing the Notes & Developments for one issue per annual volume.

We are currently seeking Harvard graduate students and postdoctoral fellows from any school to contribute papers to be published in JLB’s Notes & Developments section in early 2017. We will consider student papers that will be generated specifically for JLB, as well as papers that have been (or will be) initially written as student notes or course papers and edited for this particular purpose. JLB Notes & Developments are limited to 5000 words, including footnotes and references, and should be on a topic of relevance to law and the biosciences, in particular a topic of relatively recent concern, controversy, or change. They should focus on describing the issue at hand, explaining why it is relevant to scholars, and providing analysis and questions for further consideration. For recent examples of submissions by Harvard students, check out the April 2016 issue of the JLB. Continue reading