Hundred dollar bills rolled up in a pill bottle

How Soon Could President Biden Enable Generic Competition to Xtandi? Very Quickly, If There Is the Will.

By James Love

On March 21, 2023, the NIH, acting on behalf of HHS Secretary Xavier Becerra, rejected a petition from four cancer patients asking HHS to use the government’s rights in the prostate cancer drug enzalutamide, in order to remedy pricing abuses by the patent holder. The abuse is charging U.S. cancer patients two to six times as much as other high income countries for Astellas’ and Pfizer’s Xtandi, a drug invented on federal grants.

The cancer patients could seek a remedy to the abusive and discriminatory pricing because the U.S. government had funded the R&D for each of the three patented inventions that are currently blocking generic competition.

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Washington DC, USA - FEBRUARY 10 2021: President Joe Biden delivers remarks to Department of Defense personnel, with Vice President Kamala Harris and Secretary of Defense Lloyd J. Austin III.

4 Years into the COVID-19 Pandemic: Where We Stand

By Jennifer S. Bard

The White House is preparing to shut down their COVID Task Force this May, in conjunction with ending the public health emergency — the latest in a series of astounding and shortsighted decisions that put individual Americans at as great a risk from serious harm as a result of catching COVID-19 as at any stage in the pandemic.

By declaring the pandemic over by fiat, the government is giving up the fight when they should be redoubling their efforts. Not only is COVID still very much with us, but all existing methods of preventing infection have either been severely weakened by the virus’ mutations, or simply abandoned. Additionally, more is known of the harm COVID causes past the initial infection.

There is nothing vague or subtle about the “end” of a disease outbreak. Either cases actually disappear, as with seasonal influenza, or they are dramatically reduced through a vaccine that prevents further transmission, as happened with measles and polio. Neither event has happened here. Instead, like HIV, which continues to be an ongoing public health emergency, the virus continues to infect and mutate.

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Magazines on wooden table on bright background.

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

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.

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Medicine doctor and stethoscope in hand touching icon medical network connection with modern virtual screen interface, medical technology network concept

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.

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Public toilet that is bright and clean with a male-female sign and the toilet for the disabled is clearly distinguished.

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.

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Gavel and stethoscope.

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.

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Modern Medical Research Laboratory with Computer Showing Virus Genome Research Software. Scientific Laboratory Biotechnology Development Center Full of High-Tech Equipment.

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.

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Asthma inhalers on table against blurred background.

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.

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