pills

Everything You Wanted to Know About Expanded Access but Were Afraid to Ask, Part 1

By Alison Bateman-House, Hayley M. Belli, and Sage Gustafson

This series is adapted from a webinar hosted by PRIM&R on August 5, 2021: IRB Review of Expanded Access Protocols that Collect Real World Data: Considerations and Guidance.

Part 1: What is Expanded Access and How Does it Work?

Expanded Access (EA) is a regulatory mechanism that allows patients, through their physicians, to request the use of an unapproved medical product in a treatment setting.

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Bill of Health - Globe and vaccine, covid vaccine

Reclaiming Global Public Health

By Zain Rizvi

By December 2020, the world had astonishingly powerful tools against COVID-19. New mRNA vaccines, underpinned by decades of public investment, had been authorized by global regulators. Yet the promise of the vaccines was unevenly realized: deep fault lines emerged between those who were able to secure vaccines and those left behind, or what South Africa’s president Cyril Ramaphosa called “vaccine apartheid.”

Dose shortages elevated the role of pharmaceutical executives. Fielding calls from heads of state, they decided what vaccine deliveries to prioritize, shaping which countries could protect lives and livelihoods. The answer to one of the most important public health questions of our time — who gets access to vaccines? — was mostly determined neither by political representatives nor scientists, but by corporate executives.

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Vial and syringe.

Can Children Consent to the COVID Vaccine? The Case of Foster Care and Juvenile Justice

By Victoria Kalumbi

Despite pediatric COVID-19 vaccine availability, many youth remain unvaccinated, and are thus at higher risk of life-altering outcomes as a result of contracting COVID-19.[1]

Some children may be unvaccinated by no choice of their own, but instead because of decisions made by parents, guardians, or state or local government officials.

In this post, I argue that young people should have the opportunity to consent to vaccines. I focus on the specific case of children in foster care and the juvenile justice system, as they are particularly vulnerable amid the ongoing pandemic. However, the legal and political avenues explored in this piece to ensure that young people have a stake in their health and vaccine status are broadly generalizable to all children.

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concept illustration of genes in DNA.

A Response to ‘Another Legislative Attempt to Revive Gene Patenting’

By Emily Michiko Morris

Professor Jorge Contreras’ commentary on the Patent Eligibility Restoration Act of 2022 objects to Senator Thom Tillis’ recently introduced bill. Specifically, he argues that proposed inclusion of isolated and purified human genes and other naturally occurring substances as patent eligible subject matter is unnecessary and would both stymie research and obstruct access to medicine. But the truth is these criticisms rely mostly on narrative and anecdote rather than rigorous empirical evidence. (Professor Contreras has written an article acknowledging the many narratives behind the gene patenting debate: see Narratives of Gene Patenting, 43 Fla. St. U. L. Rev. 1133 (2016)).

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Pile of colorful pills in blister packs

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

By Ameet SarpatwariAviva Wang, 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 July. The selections feature topics ranging from how Wikipedia pages communicate drug efficacy information, to addressing pharmaceutical industry payments to physicians, to the frequency with which the Food and Drug Administration removes hazardous dietary supplements from the market. A full posting of abstracts/summaries of these articles may be found on our website.

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Bill of Health - American currency (50, 100, 20) on a wooden table next to pills and spilling bottle of pharmaceuticals

Many Hospitals Receiving Discounted Drugs May Not Offer Patients Pharmaceutical Assistance

By Amy Cook, JD, Jonathan Larsen, JD, MPP, and Sabrina Ruchelli, JD

Section 340B of the Public Health Service Act requires that pharmaceutical manufacturers give discounts on specified outpatient drugs to certain covered entities who typically serve low-income or otherwise underserved patients, including hospitals and clinics.

However, according to the Government Accountability Office (GAO), there are no measures built into the program to assure that 340B program discounts are being used to support care for low-income populations, let alone to improve access to medicines discounted through the program.

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yellow capsules on a blue background.

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

By Ameet Sarpatwari, Alexander Egilman, Aviva Wang, andAaron 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.

Below are the citations for papers identified from the month of June. The selections feature topics ranging from a discussion of potential pathways to enable government patent use before nonpatent exclusivities expire, to an examination of medical oncologists who receive more than $100,000 annually from pharmaceutical companies, to an analysis of the launch prices of new drugs from 2008-2021. A full posting of abstracts/summaries of these articles may be found on our website.

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One pill on mint green background.

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

By Ameet Sarpatwari, Alexander Egilman, Aviva Wang, 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.

Below are the citations for papers identified from the month of May. The selections feature topics ranging from a discussion of how the US Patent and Trademark Office could more closely scrutinize applications for drug patents whose siblings have been discontinued in other jurisdictions, to an evaluation of FDA advisory committee referrals for new drugs approved from 2010-2021, to an analysis of the patents and regulatory exclusivities on inhalers approved from 1986-2020. A full posting of abstracts/summaries of these articles may be found on our website.

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Vaccines.

COVID-19, Patents, and Trade Secrets

By David Gindler & Jasper L. Tran

Has the worldwide distribution of COVID-19 vaccines been impacted by patent rights? David Gindler, head of IP at Milbank LA, and Jasper L. Tran, senior associate at Milbank LA, argue that the story is much more complicated — making vaccines involves much more than waiving patents, they explain.

The following article, which is adapted from the authors’ conversation with Vanderbilt Law Review podcast editor Jacob Goodman on Hot Topics in Intellectual Property Law, provides an overview of the complicated intellectual property landscape associated with COVID-19 vaccines and therapeutics.

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A male pharmacist is examining a drug from a pharmacy inventory.

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

By Ameet Sarpatwari, Alexander Egilman, Aviva Wang, andAaron 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.

Below are the citations for papers identified from the month of April. The selections feature topics ranging from a discussion of manufacturer’s restricted delivery of 340B drugs to contract pharmacies and ensuing litigation, to an analysis mapping the European patent landscape for medical uses of known products, to an evaluation of the clinical benefit of novel drugs approved in the U.S. from 2018-2019. A full posting of abstracts/summaries of these articles may be found on our website.

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