Month: July 2016

FitBits Be Free: General Wellness Products Are Not (Generally) Medical Devices

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By Nicolas Terry

The FDA has issued a final guidance on low risk wellness devices, and it is refreshingly clear. Rather than applying regulatory discretion as we have seen in the medical app space, the agency has made a broader decision (all usual caveats about non-binding guidances aside) not to even examine large swathes of wellness products to determine whether they are Section 201(h) devices. As such, this guidance more closely resembles the 2013 guidance that declared Personal Sound Amplification Products (PSAPs) not to be medical devices (aka hearing aids).

The FDA approach to defining excluded products breaks no new ground. First, they must be intended for only general wellness use and, second, present a low risk. As to the former, FDA has evolved its approach to referencing specific diseases or conditions. Make no such reference and your product will sail through as a general wellness product. Thus, claims to promote relaxation, to boost self-esteem, to manage sleep patterns, etc., are clearly exempt. On the other hand, the agency will clearly regulate products that claim to treat or diagnose specific conditions. Read More

Introducing a new global antibiotic R&D partnership

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By Kevin Outterson

Yesterday US HHS announced a new global partnership to fund pre-clinical antibiotic R&D, coordinated by the Boston University School of Law. The partnership is known as CARB-X, which is the abbreviation for the Combating Antibiotic-Resistant Bacteria (CARB) Biopharmaceutical Accelerator.  CARB-X is the culmination of one key part of the US National Action Plan on antibiotic resistance.  Background paper in Nature Reviews Drug Discovery.

Under the grant, BU Law will coordinate more than $350 million in new funds for R&D over the next five years, in partnership with BARDA, NIAID, the Wellcome Trust, the AMR Centre, MassBio, the California Life Sciences Institute and the Broad Institute at Harvard and MIT.  Kevin Outterson is the PI and Executive Director of CARB-X.

While the bulk of the project funds pre-clinical R&D, we are also interested in the role of law, IP and other innovation incentives, using the unique dataset that CARB-X will generate.

Is Gaming the Transplant List an Ethical Dilemma?

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By Shailin Thomas

NPR recently published a thought-provoking piece discussing an ethical dilemma doctors face when treating patients in need of organ transplants. Transplant list priority is designed to depend upon the relative sickness of patients, allocating organs to those who need them most. However, instead of lab results or other direct measures, the list uses the treatment a patient is receiving as a proxy for her condition. As a result, doctors have the ability to move their patients up the list by prescribing — or over-prescribing — more extreme and invasive treatments.

It’s understandable why this temptation exists — doctors go into medicine to heal, and I imagine it’s difficult to refrain from taking an action which could very well save a patient’s life. But should this be an ethical dilemma?

Bumping a patient up the transplant list could certainly save a life, but that life could come at the expense of another’s. The problem is that organ transplants are inherently zero-sum — if one patient goes up on the list, another must come down. If one person gets an organ, that means another doesn’t. Furthermore, over-treating to influence transplant priority has consequences that reach beyond any individual patient, potentially furthering inequality in the transplant system and contributing to unsustainable health care spending. Read More

Fighting the Next Pandemic: Airline Vaccine Screens

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By Christopher Robertson

Whether it is Ebola, H1N1, the season flu, or the next nasty bug that we cannot yet even imagine, if we wanted to efficiently spread the disease, one could not do much better than packing several Flight routeshundred people into a cylinder for a few hours, while they eat, drink, defecate, and urinate.  Even more, to make sure that the disease cannot be contained in a particular locality, we could build thousands of those cylinders and move them rapidly from one place to another worldwide, remix the people, and put them back in the cylinders for return trips back to their homes, schools, and jobs.

We are (hopefully) not going to stop airline travel.  But we can make it a lot safer, by ensuring that almost everyone who boards these flights is vaccinated.  That’s the thesis of a new paper out this week.

Airlines carry two million people every day.  And, prior research has shown that airline travel is a vector of disease.  In fact, when the September 11 attacks caused airline travel to fall, seasonal flu diagnoses fell too.

The threat of pandemics is quite real, and more generally, the mortality and morbidity associated with infectious disease is a severe public health burden.  About 42,000 adults and 300 children die every year from vaccine-preventable disease.  New vaccines are on the horizon.

Arguably, airlines have market-based and liability-based reasons to begin screening passengers, whether for vaccinations generally or for particular ones during an outbreak.  Although the states have traditionally exercised the plenary power to mandate vaccinations, and have primarily focused on children in schools, the U.S. federal government also has substantial untapped power to regulate in this domain as well.

Learning from mistakes in the NHS: a special report by the Parliamentary and Health Service Ombudsman (PHSO) into how the NHS failed to investigate properly the death of a three-year-old child.

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By John Tingle

In the UK where health is concerned money is a particularly poor compensator for the loss of a limb, faculty or even a family member. In my experience patients who have suffered adverse health incidents, negligence, more often than not, are not primarily motivated by obtaining monetary compensation. They seek in the main an explanation of what occurred and why, an apology and an assurance that what happened will not happen to anybody else; that lessons have been learned.

The NHS (National Health Service) for decades has been unable to provide a satisfactory complaints and patient adverse incident investigation service which provides these outcomes generally. More often than not patients have to resort to complaining or beginning litigation in order to find out what happened and why and the process that they have to embark on can alienate them even more as they soon hit major and seemingly unsurmountable obstacles. The NHS maintains a defensive and blame ridden culture when errors happen as the terrible events of Mid Staffordshire revealed.

The report Read More

DUE AUGUST 5: Call for Apps – Petrie-Flom Center Harvard Grad Student Fellowship

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THE PETRIE-FLOM CENTER

STUDENT FELLOWSHIP PROGRAM, 2016-2017

CALL FOR APPLICATIONS 

The Center and Student Fellowship. The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics is an interdisciplinary research program at Harvard Law School dedicated to the scholarly research of important issues at the intersection of law and health policy, including issues of health care financing and market regulation, biotechnology and intellectual property, biomedical research, and bioethics. The Student Fellowship Program is designed to support closely-mentored student research in these areas. For more information on our recent fellows and their work, see our website.

Eligibility. The student fellowship program is open to all Harvard graduate students who will be enrolled at the University during the fellowship year and who are committed to undertaking a significant research project and fulfilling other program requirements. Although the fellowship is open to all graduate students, including those in one-year programs, we encourage those who are in multi-year programs at Harvard to wait until after their first year to apply.

Requirements. All student fellows will have the following responsibilities: Read More

Marking the 40th Anniversary of In re Quinlan’s Landmark Contribution to Death & Dying Jurisprudence

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by Norman L. Cantor

In 1976, the N.J. Supreme Court issued a remarkably insightful ruling regarding the legal status of a permanently unconscious patient.  In re Quinlan served as a judicial beacon guiding development of death & dying jurisprudence.  Its impact is reminiscent of the judicial role played by Brown v. Board of Education in public education.

To appreciate the wondrous nature of Quinlan, recall the setting and background of the case.  In 1975, a 22 year-old woman, Karen Ann Quinlan, was lying unconscious in a N.J. hospital following 2 anoxic episodes caused by toxic ingestions.  She was sustained by a mechanical respirator and a naso-gastric tube.  The diagnosis was PVS (permanent vegetative state) and the prognosis was that the patient would inevitably die within a year without regaining consciousness.  Ms. Quinlan’s devoted parents reluctantly concluded that their daughter would not want to be maintained in her dismal, hopeless condition.  Their priest and spiritual advisor told them that Catholic doctrine would permit withdrawal of “extraordinary” medical intervention such as the respirator.   But when the parents asked the attending neurologist, Dr. Morse, to withdraw Karen’s respirator, he refused.  He contended that professional medical standards precluded that course.  The hospital concurred.  Facing this resistance, Ms. Quinlan’s father turned to the N.J. chancery court seeking formal appointment as his daughter’s guardian with explicit authorization to direct withdrawal of the respirator.

A variety of interested parties responded to Mr. Quinlan’s chancery petition and they all opposed it.  The county prosecutor asserted that pulling the respirator plug would constitute homicide and the state attorney general concurred.  The attending physicians and the hospital contended that pulling the plug would violate their professional responsibilities to the patient.  And a special guardian ad litem appointed to represent Karen Ann Quinlan insisted that it was in the helpless patient’s best interests to have her life prolonged.  The lower court denied the father’s petition and Mr. Quinlan appealed.

On appeal, the N.J. Supreme Court in 1976 faced the unenviable task of shaping legal policy toward medical conduct likely to precipitate the death of a helpless patient.  This was largely uncharted legal territory with no definitive precedents in state or federal courts.  Common sense said that it can’t be a legal mandate to keep pumping fluids and gases into moribund patients until the last possible breath.  Yet a chorus of naysayers proclaimed that pulling the respirator plug on Ms. Quinlan would be unlawful homicide, or a breach of professional medical responsibility to preserve patients’ lives, or a violation of a guardian’s fiduciary obligation to act in a ward’s best interests.  And even if some circumstances might warrant removal of life-preserving medical interventions, hard questions existed about who is entitled to be the decision maker and what test or criteria govern such surrogate decision making.

Read More

Recent Developments in Off-Label Promotion

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By Chris Robertson

July has been a busy month for those following the controversy around off-label promotion of drugs and devices.  As many on this blog know, federal law requires that prior to marketing any drug or device, companies must prove to the FDA’s satisfaction that it is safe and effective for all intended uses.  If the company reveals that it intends unapproved uses,  sales of the drug or device are illegal.  Nonetheless, physicians can prescribe “off-label,” and companies are free to sell for those known-but-not-intended purposes.

This carefully-wrought policy may seem convoluted, but it serves important epistemic and economic purposes, as I have argued elsewhere.  This month, I have a new draft paper on SSRN, assessing recent assertions of a First Amendment right to promote for uses not approved by the FDA, and consider whether such a right would be equally applicable to drugs that have no FDA-approved label at all. I worry that the entire pre-market approval regime may be at stake. Feedback on that intentionally-provocative analysis is quite welcome.

On Wednesday, two medical device company executives, were convicted of promoting a product “to deliver steroid medications to patients’ sinuses, though it was only approved by the U.S. Food and Drug Administration for keeping sinuses open.”  The prosecutors thought the case was particularly egregious, because the company had intended the broader use to deliver medicine all along, but sought to mislead the FDA, denying it the chance review the safety and efficacy of the real intended use.  The jury instructions and verdict form  are particularly interesting, to see how the government’s trial strategy avoids the holding of a Second Circuit case of Caronia, which overturned a conviction on First Amendment grounds.  I’ll return with some analysis later. Read More

Jon Mark Hirshon on ‘The Week in Health Law’ Podcast

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By Nicolas Terry and Frank Pasquale

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Listen here! Our guest this week is Jon Mark Hirshon, M.D., M.P.H., Ph.D., an Associate Professor in the Department of Emergency Medicine and in the Department of Epidemiology and Public Health at the University of Maryland School of Medicine. Jon Mark is also on the board of the American College of Emergency Physicians, and is an internationally recognized expert on acute care. His teams have trained approximately 900 physicians from countries in the Middle East in topics ranging from clinical care of trauma patients to disaster preparedness to research methods.Our lightning round featured discussions of an issue brief, “How Has the Affordable Care Act Affected Health Insurers’ Financial Performance?,” as well as a news story on some insurers’ dissatisfaction with the ACA. While health costs may increase GDP, they are hurting some insurers’ bottom lines. On the health IT front, we focused on ransomware and non-covered entities’ data. And continuing our wellness coverage, we mentioned employers’ new enthusiasm for mobile monitoring of employees’ mental health–what Rachel Emma Silverman’s twitter feed has jokingly called “#textualhealing.”

During his interview, Jon Mark focused on policy issues in acute care. He discussed a lawsuit filed by the American College of Emergency Physicians against the federal government reflecting ACEP’s concerns about reimbursement. Jon Mark also described the many challenges now facing emergency departments, ranging from narrow networks that fail to fairly compensate care, to user-unfriendly IT systems. Jon Mark also offered practical solutions for increasing access to acute care–an urgent policy concern given America’s dismal overall grades for access to emergency 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

Call for Proposals: BioIP Faculty Workshop

Nadia Sawicki Leave a comment

The American Society for Law, Medicine & Ethics (ASLME) is pleased to announce the second annual bioIP Faculty Workshop on May 5, 2017 at Loyola University of Chicago School of Law in Chicago, IL.

The Workshop offers a unique opportunity for three scholars in their first decade of teaching to present their work in progress for in-depth critique and commentary by respected senior scholars in the field.

Topics for the workshop are at the intersection of biotechnology, life sciences, food and drug law, and intellectual property (hence, bioip), broadly defined. A Review Committee comprised of faculty from the Boston University School of Law, Georgia State University College of Law, and the Loyola University Chicago School of Law will select papers for the Workshop in a blind process. Papers should present an original thesis and contribute to scholarly literature. The Workshop will not review published work.

Scholars with less than ten years of teaching experience, including VAPS and Fellows, are eligible for participation in the Workshop. Those interested in participating should submit an abstract (up to 750 words) of the proposed paper (without identifying details) along with a c.v. to Ted Hutchinson, Executive Director of the ASMLE at thutchinson@aslme.org by Oct 14, 2016.

Selected abstracts will be announced later in Fall 2016 with the full draft papers due by April 1, 2017. The organizers will cover reasonable travel and lodging expenses for selected scholars.

For questions, please email Cynthia Ho at cho@luc.edu.