Skip to Content
Consequences of rush… image

Consequences of rush to emergency use authorization of bamlanivimab


Mia Lussier, Michelle N. Meyer (Former Academic Fellow), and Eric Wright
American Journal of Health-System Pharmacy

Until November 2020, treatment for nonhospitalized patients with acute SARS-CoV-2 infection was largely limited to supportive measures. This changed on November 9, 2020, following emergency use authorization (EUA) for use of bamlanivimab, a…

Integrating New… image

Integrating New Effectiveness Data Into US Food and Drug Administration-Approved Drug Labeling


Bishal Gyawali, Jonathan J. Darrow (Former Student Fellow), and Aaron S. Kesselheim
JAMA Internal Medicine

A prescription drug’s package insert (or labeling) is a document written by the manufacturer and first approved by the US Food and Drug Administration (FDA) as part of…

Biosupremacy: Big… image

Biosupremacy: Big Data, Antitrust, and Monopolistic Power Over Human Behavior


Mason Marks (Senior Fellow and Project Lead on POPLAR)
U.C. Davis Law Review

Since 2001, five leading technology companies have acquired more than 600 other firms while avoiding antitrust enforcement. By accumulating technologies in adjacent or unrelated industries, these companies have grown so powerful that…

COVID-19 Antibody… image

COVID-19 Antibody Testing as a Precondition for Employment: Ethical and Legal Considerations


Sara Gerke (Former Research Fellow), Gali Katznelson, Dorit Reiss, and Carmel Shachar (Executive Director)
Journal of Law, Medicine & Ethics

Employers and governments are interested in the use of serological (antibody) testing to allow people to return to work before there is a vaccine for SARS-CoV-2. We articulate the preconditions…

Future Directions for… image

Future Directions for Human Rights Praxis in Health: The Imperative of (Re)claiming the Public


Alicia Ely Yamin (Senior Fellow in Global Health and Rights)
La Revue des Juristes de Sciences Po

Alors que la crise sanitaire perdure et continue de bouleverser notre quotidien, ce numéro 21 de la Revue des Juristes fait tragiquement échos à l’actualité.…

Off-Label Innovation image

Off-Label Innovation


David A. Simon (Research Fellow, Digital Home Health)
Georgia Law Review

Modern medicine faces many significant challenges. This Article is about two of them. The first is that approved drugs have many potential therapeutic uses that are never identified, investigated, or…

The American Rescue… image

The American Rescue Plan Act of 2021: A Historic if Transitory Expansion of the ACA


Ely Y. Adashi and I. Glenn Cohen (Faculty Director)
JAMA

The American Rescue Plan Act of 2021 (ARPA), a $1.9 trillion economic stimulus bill, was signed into law by President Biden on March 11, 2021.1 Although the bill largely focused on the devastation related…

Encouraging… image

Encouraging Interagency Collaboration: Learning from COVID-19


Rachel Sachs (Former Academic Fellow)
Journal of Law & Innovation

In the health innovation context, federal regulatory authority is sharply fragmented among different agencies. The National Institutes of Health, Food and Drug Administration, Centers for Medicare and Medicaid Services, and…

El Derecho a la salud en el campo jurídico y sanitario. Hacia la construcción de la justicia sanitaria.


María Natalia Echegoyemberry (Affiliated Researcher)
Revista Debate Público Reflexión de Trabajo Social

En el sistema jurídico Argentino el derecho a la salud es considerado un Derecho Humano fundamental interdependiente de los derechos económicos, sociales, culturales y ambientales (DESCA),…

Emergent Medical Data image

Emergent Medical Data: Health Information Inferred by Artificial Intelligence


Mason Marks (Edmond J. Safra Center and Petrie-Flom Center Fellow in Ethics of Technological and Biomedical Innovation)
UC Irvine Law Review

Artificial intelligence (AI) can infer health data from people’s behavior even when their behavior has no apparent connection to their health. AI can monitor one’s location…

Amicus Curiae Brief:… image

Amicus Curiae Brief: Case of Manuela and Family v. El Salvador


Center for Human Rights and Global Justice co-signed by Alicia Yamin (Senior Fellow Global Health and RIghts)
Inter-American Court of Human Rights

Professor Philip Alston and Leah Motzkin have the honor of submitting this Amicus Curiae brief to the Inter-American Court of Human Rights (hereinafter also referred to as “the Court…

Assessing the Impact… image

Assessing the Impact of US Food and Drug Administration Breakthrough Therapy Designation Timing on Trial Characteristics and Development Speed


Lisette Pregelj, Damian C. Hine, Aaron S. Kesselheim, and Jonathan J. Darrow (Former Student Fellow)
American Society for Clinical Pharmacology and Therapeutics

The US Congress created the Breakthrough Therapy designation in 2012 to expedite drug development and review through efficient clinical trial design and intensive interaction with US Food and Drug Administration (FDA)…

Modernizing Medical… image

Modernizing Medical Licensure to Facilitate Telemedicine Delivery After the COVID-19 Pandemic


Carmel Shachar (Executive Director), Amar Gupta, and Gali Katznelson
JAMA Health Forum

During the COVID-19 pandemic, telemedicine has been a substantial tool in promoting resilience in the health care system. Beyond the pandemic, telemedicine has potential to expand access to care and…

Few new drugs deserve… image

Few new drugs deserve expedited regulatory treatment


Jonathan J Darrow (Affiliated Faculty)
Journal of Managed Care and Specialty Pharmacy

Safety testing of new drugs has been required since the 1938 Federal Food, Drug, and Cosmetic Act, but applications were automatically approved under that law unless the US Food and Drug…

The US worried about… image

The US worried about vaccine tourists. Now it’s encouraging them.


Eileen Guo, featuring I. Glenn Cohen (Faculty DIrector)
MIT Technology Review

The British expat arrived on a red-eye flight from his home in Nairobi, Kenya, at New York’s John F. Kennedy International Airport on Friday, May 21, with the intention…

The Rhetorical… image

The Rhetorical Transformations and Policy Failures of Prescription Drug Pricing Reform under the Trump Administration


Rachel Sachs (Former Academic Fellow)
Journal of Health Policitcs, Policy, and Law

Throughout his four years in office, President Trump made prescription drug pricing a focus of his policy agenda. President Trump not only used strong language to criticize the pharmaceutical industry…

“A Cohort of Pirate… image

“A Cohort of Pirate Ships”: Biomedical Citizen Scientists’ Attitudes Toward Ethical Oversight


Meredith Trejo, Isabel Canfield, Whitney Bash Brooks, Alex Pearlman (Former Communications Manager), and Christi Guerrini
Citizen Science: Theory and Practice

As biomedical citizen science initiatives become more prevalent, the unique ethical issues that they raise are attracting policy attention. One issue identified as a significant concern is the ethical oversight…

For a second year,… image

For a second year, Harvard Law to offer pre-term ‘Zero-L’ course to other law schools for free


HLS News Staff, featuring I. Glenn Cohen (Faculty Director)
Harvard Law Today

Harvard Law School today announced plans to make its online, pre-term course for incoming law students, Zero-L, available to other U.S. law schools for free again for a second…

‘That would be… image

‘That would be dreadful’: The ethical, legal, and social challenges of sharing your Alzheimer’s disease biomarker and genetic testing results with others


Emily A. Largent (Former Student Fellow), Shana D. Stites, Kristin Harkins, and Jason Karlawish
Journal of Law and Biosciences

Several large clinical trials are underway to discover therapies to delay or prevent the onset of dementia caused by Alzheimer’s disease (AD). A common feature of these trials…

Law, Ethics, and COVID-19 image

Law, Ethics, and COVID-19: An interview with I. Glenn Cohen


Mark Polk, featuring I. Glenn Cohen (Faculty Director)
Harvard Health Policy Review

HHPR Editor Mark Polk interviewed I. Glenn Cohen, the James A. Attwood and Leslie Williams Professor of Law, Deputy Dean, and Faculty Director of the Petrie-Flom Center for Health Law…