Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues. Below are the citations for papers identified from the month of February. The selections feature topics ranging from an analysis of the approval and marketing of biosimilars with a skinny label and their associated Medicare savings, to a discussion of the Philips Respironics recall and the need for reforms to U.S. medical device regulation, to a review of price negotiation processes in peer countries and potential lessons for Medicare price regulation. A full posting of abstracts/summaries of these articles may be found on our website.
Governing Health Data for Research, Development, and Innovation: The Missteps of the European Health Data Space Proposal
By Enrique Santamaría
Together with the Data Governance Act (DGA) and the General Data Protection Regulation (GDPR), the proposal for a Regulation on the European Health Data Space (EHDS) will most likely form the new regulatory and governance framework for the use of health data in the European Union. Although well intentioned and thoroughly needed, there are aspects of the EHDS that require further debate, reconsiderations, and amendments. Clarity about what constitutes scientific research is particularly needed.
Trans-antagonism Creates Space for the Worst Side of the Law
By Adam Herpolsheimer
By no means the first foray into gender identity-based discrimination, the legacy of North Carolina’s HB2 (2016) — known colloquially as the bathroom bill — is one we cannot shake. The law has since been repealed but was ultimately a turning point for what was possible in terms of legal action against the trans community. HB2 was particularly bothersome and ill-advised because of the legal mechanism it used to achieve its goals: preemption.
Public Health Law and Civil Rights Laws Must Work Together to Rise to the Challenge of Long COVID
By Elizabeth Pendo
Amid the ongoing COVID-19 pandemic, the need for public health laws and policies that align with and reinforce civil rights protections for disproportionately impacted populations is greater than ever. In particular, disability rights laws will be critical for responding to the millions of Americans who experience lasting or recurring symptoms after acute COVID-19 infection (commonly referred to as “long COVID”). This article will discuss the importance of the Americans with Disabilities Act (ADA) in protecting the rights of people with long COVID and other disabilities in the workplace, in health care, and in disability and other benefits in order to chart an equitable path forward.
How Artificial Intelligence is Revolutionizing Drug Discovery
By Matthew Chun
In recent months, generative artificial intelligence (AI) has taken the world by storm. AI systems like ChatGPT and Stable Diffusion have captured the imagination of the masses with their impressive and sometimes controversial ability to generate human-like text and artwork. However, it may come as a surprise to some that — in addition to writing Twitter threads and dating app messages — AI is also well underway in revolutionizing the discovery of life-saving drugs.
Monthly Round-Up of What to Read on Pharma Law and Policy
By Ameet Sarpatwari, Liam Bendicksen, 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, policy analyses, and editorials on health law and policy issues relevant to current or potential future work in the Division.
Below are the abstracts/summaries for papers identified from the month of January. The selections feature topics ranging from a study of inhaler manufacturers’ revenues after the expiration of primary patents, to an analysis of the clinical value of drugs that companies heavily market to consumers on television, to an exploration of how the public sector and academic institutions have contributed to gene therapy innovation. A full posting of abstracts/summaries of these articles may be found on our website.
Should TikTok Doctors Owe Any Duty of Care Toward Their Followers?
By Sarah Gabriele
Doctors are now using social media platforms to spread medical knowledge and to interact with the communities that they are actively building.
This trend poses new ethical questions for physicians who want to create and engage with their communities on social media. Read More
False and Deceptive Health Claims: Buyers Beware
By Aparajita Lath
When it comes to health-related consumer purchases, buyers surely need to beware.
This is because the regulatory landscape of health-related products contains loopholes that allow false or misleading claims to proliferate. This article reviews recent instances of the issue, and discusses relevant regulations.
The Public Health Case Against Gas Appliances
By Heather Payne and Jennifer D. Oliva
Gas appliances’ health impacts pose a grave danger to tenant health and safety.
In a forthcoming article, we argue that the mere presence of natural gas appliances in the home renders a dwelling uninhabitable due to their potential health harms. We further contend that tenants should invoke the implied warranty of habitability to eliminate the continued exposure to natural gas appliance-generated indoor air pollutants.
When Crafting Public Health Policy, the Perfect Shouldn’t Be the Enemy of the Good
By Daniel Goldberg
The nirvana fallacy “is the informal fallacy of comparing actual things with unrealistic, idealized alternatives.” Practice and policy guided by the nirvana fallacy discourages any action at all short of a perfect solution.
Sound familiar? It’s one justification for pandemic policy inaction in a nutshell.