The Newest 21st Century Cures Draft Moderates, But Doesn’t Eliminate, Controversy

By Rachel Sachs

Earlier this evening, the House of Representatives released the most recent draft of the 21st Century Cures Act. This is the fifth time I’ve blogged about the Act (prior posts here, here, here, and here), which has ballooned from a 200-page discussion draft in April 2015 to a 996-page draft version today. (The House has a 44-page summary here for those with more limited time.) To be fair, the Act now contains a whole set of provisions around mental health, substance abuse, and child and family services which were not originally part of the Act. The 21st Century Cures Act is the biggest Christmas tree bill I’ve ever had occasion to read.

There will be an enormous amount of commentary on different parts of the bill, so here are some quick thoughts on the new draft, focusing not only on the provisions which are likely to attract the most attention, but also on a few quieter provisions that are nonetheless worthy of scrutiny.

Some controversial provisions have been eliminated entirely or softened greatly. One of the most controversial provisions in the last draft of the bill would’ve “farm[ed] out the certification of safety of modified devices to third parties, circumventing the FDA altogether.” That provision seems to be absent from the new draft. The last draft, in creating a program for breakthrough review of medical devices, controversially called for the use of “shorter or smaller clinical trials” for those devices. The new draft asks the Secretary only to ensure that the design of such clinical trials is “as efficient and flexible as practicable, when scientifically appropriate” (section 3051).

Other controversial provisions remain, sometimes under new names. One of the most troubling provisions in the previous draft of the bill would’ve created a program for the use of “clinical experience” evidence in drug approvals. Rather than relying on the gold standard of randomized clinical trials, this provision “would[‘ve] require the Secretary to establish a draft framework for implementing” such evidence. The new draft keeps this provision but changes the term “clinical experience” to “real world evidence” (section 3022). To be sure, this provision gives enormous discretion to the Secretary to limit (and maybe even reject) the use of such evidence. But in light of recent high-profile clinical trial failures, most notably just two days ago, we ought to be concerned about claims that the FDA is too slow and imposes too stringent requirements on drug approvals.

Continue reading

Premature baby left to die alone in sluice room, report reveals: A looming patient safety crisis in the NHS?

By John Tingle

BBC News reported, 24/11/2016 on the Pennine Acute Hospitals NHS Trust review of its Royal Oldham and North Manchester General hospitals which identified several ‘unacceptable situations’. The BBC news item states that the review document

“…described how a premature baby had arrived “just before the legal age of viability” – at 22 weeks and six days – but staff did not find “a quiet place” for the child’s mother “to nurse her as she died and instead placed her in a Moses basket and left her in the sluice room to die alone”.

The report goes on to catalogue a number of other shocking events that occurred. Continue reading

Jordan Paradise on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

Subscribe to TWIHL here!

twihl 5x5

Loyola Chicago law professor Jordan Paradise joins us to discuss some of her recent work in life sciences law. Jordan’s recent interests span nanotechnology, synthetic biology, precision medicine, gene editing, and electronic cigarettes.  Her publications have appeared in both peer-reviewed and legal publications.

We start with a review of some of the regulatory issues involving e-cigarettes, and discuss the 2016 FDA regulations. We then move into a discussion of FDA regulation of biologics and biosimilars and Jordan explains naming and substitution issues.

Jordan’s recent publications include research on how the FDA could regulate e-cigarettes, strategic misuse of risk evaluation and mitigation strategies (REMS), and cutting edge developments in the law of biosimilars.

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

REGISTER NOW (12/9)! Paying Research Participants: Ethical and Regulatory Parameters

Rolled up US paper banknote in a test tube rack representing the costs of medical research

Paying Research Participants: Ethical and Regulatory Parameters
December 9, 2016 8:00 AM – 12:30 PM
Milstein East ABC (2036), Wasserstein Hall
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Register for this event

Description

This symposium will bring together a variety of experts to discuss key ethical and legal questions regarding offers of payment to research participants. Panels will cover:

  • Why payment is offered to research participants
  • Regulatory parameters governing payment
  • Whether payment to research participants should be considered exceptional, compared to payment in other contexts
  • How offers of payment affect participants
  • How to define coercion and undue influence with regard to paying research participants
  • Which factors should be considered when evaluating proposed payments
  • The problem of low payment

This event is free and open to the public, but space is limited and registration is required. Register now!

Working Agenda

Continue reading

CALL FOR ABSTRACTS, DUE 12/2! 2017 Annual Conference, “Transparency in Health and Health Care: Legal and Ethical Possibilities and Limits”

Medical care prices against a white background

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is pleased to announce plans for our 2017 annual conference, entitled: Transparency in Health and Health Care: Legal and Ethical Possibilities and Limits.

Transparency is a relatively new concept to the world of health and health care, considering that just a few short decades ago we were still in the throes of a “doctor-knows-best” model. Today, however, transparency is found on almost every short list of solutions to a variety of health policy problems, ranging from conflicts of interest to rising drug costs to promoting efficient use of health care resources, and more. Doctors are now expected to be transparent about patient diagnoses and treatment options, hospitals are expected to be transparent about error rates, insurers about policy limitations, companies about prices, researchers about data, and policymakers about priorities and rationales for health policy intervention. But a number of important legal and ethical questions remain. For example, what exactly does transparency mean in the context of health, who has a responsibility to be transparent and to whom, what legal mechanisms are there to promote transparency, and what legal protections are needed for things like privacy, intellectual property, and the like?  More specifically, when can transparency improve health and health care, and when is it likely to be nothing more than platitude?

This conference, and anticipated edited volume, will aim to: (1) identify the various thematic roles transparency has been called on to play in American health policy, and why it has emerged in these spaces; (2) understand when, where, how, and why transparency may be a useful policy tool in relation to health and health care, what it can realistically be expected to achieve, and when it is unlikely to be successful, including limits on how patients and consumers utilize information even when we have transparency; (3) assess the legal and ethical issues raised by transparency in health and health care, including obstacles and opportunities; (4) learn from comparative examples of transparency, both in other sectors and outside the United States.  In sum, we hope to reach better understandings of this health policy buzzword so that transparency can be utilized as a solution to pressing health policy issues where appropriate, while recognizing its true limitations.

Call for Abstracts

We welcome submissions on both the broad conceptual questions described above and more specific policy issues, including: Continue reading

Monday, 11/28, Health Law Workshop with Frances Kamm

November 28, 2016 5-7 PM
Hauser Hall, Room 104
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA

Presentation title: “Advanced and End of Life Care: Cautionary Suggestions”

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

Frances Kamm is the Littauer Professor of Philosophy and Public Policy in the Kennedy School of Government and Professor of Philosophy in the Faculty of Arts & Sciences.

She is the author of Creation and Abortion (1992); Morality, Mortality, Vol. 1: Death and Whom to Save From It (1993); Morality, Mortality, Vol. 2: Rights, Duties, and Status (1996); Intricate Ethics: Rights, Responsibilities, and Permissible Harm (2007), and, most recently, Ethics for Enemies: Terror, Torture, & War (2011). She also has published many articles on normative ethical theory and practical ethics.

Professor Kamm has held ACLS, AAUW, and Guggenheim fellowships, and has been a Fellow of the Program in Ethics and the Professions at the Kennedy School, the Center for Human Values at Princeton, and the Center for Advanced Study at Stanford.

She is a member of the editorial boards of Philosophy & Public AffairsLegal TheoryBioethics, and Utilitas, and was a consultant on ethics to the World Health Organization.