Businessman crossing fingers behind his back.

Get Your Story Straight: Patent Office Cracks Down on Inconsistent Statements Made Before the FDA

By Matthew Chun

In an effort to “promote robust and reliable patents” and increase access to life-saving drugs, the United States Patent and Trademark Office (USPTO) recently issued a Federal Register Notice clarifying the responsibilities of individuals involved in the patent application process.

In the July 29, 2022 notice, the USPTO set forth its views on the “duty of disclosure” and “duty of reasonable inquiry,” emphasizing the importance of consistency between statements made to the USPTO, the FDA, and other governmental agencies. While the goals of the Federal Register Notice are certainly noble, its disruptive practical effects leave much to be desired.

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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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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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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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Washington, USA- January13, 2020: FDA Sign outside their headquarters in Washington. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA.

Mushroom Monographs? The FDA’s Potential Role in a Legal Recreational Drug Market

By Jonathan Perez-Reyzin

Within the psychedelic legal landscape, the U.S. Food and Drug Administration (FDA) plays a central role — it is the regulatory mechanism by which drugs like MDMA and psilocybin may soon become legal for medical use.

But for many working in drug policy, medicalization is not the exclusive goal. Indeed, there have been calls for legalization of psychedelics for non-medical use — and we are seeing an early attempt at such a model in Oregon.

These efforts are not yet reaching the federal level, but it’s only a matter of time before the legalization of psychedelics and other currently illegal drugs for adult recreational use becomes a federal question, as is already occurring with marijuana. And despite the FDA’s widely recognized role in medicine, few have considered the role the FDA would play in a federal regulatory regime for the non-medical use of drugs, even though it already does regulate at least one recreational substance legal for recreational use: tobacco.

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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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hand opening white plastic pvc window at home.

It’s Time for the Federal Government to Get Back to Protecting the Nation Against COVID-19

By Jennifer S. Bard

Over the past two years, the Supreme Court has shown unprecedented hostility to efforts by both state and federal government to stop the spread of what every day turns out to be an even more deadly pandemic.

These decisions are devastating, and likely signal a continued attack on government authority, but they are not a reason to give up.

The federal government can still use its vast resources to slow the spread and continued mutation of the virus, by telling people what it knows of the danger, and what it knows about how to mitigate it.

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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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United States Capitol Building - Washington, DC.

Psychedelic Policy on the Federal Level: Key Takeaways from a Petrie-Flom Center Panel

By James R. Jolin

To navigate the myriad interests and stakes involved in creating federal psychedelic policy, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School convened a virtual panel discussion with three leading psychedelic policy advocates.

The conversation was situated against the backdrop of the “psychedelics renaissance” in the United States, which has been fueled by a wave of local and state legislation reducing or eliminating the criminal penalties associated with these substances.

Though many localities have made significant strides in addressing the legal questions surrounding psychedelic substances such as psilocybin and dimethyltryptamine (DMT), federal policymakers have not pursued similar initiatives.

Suggestions and considerations for federal psychedelic policy thus formed the substance of the discussion among the panelists:

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Pill pack.

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 March. The selections feature topics ranging from a discussion of patient assistance programs and the Anti-Kickback Statute, to an analysis of the effects of state opioid prescribing laws on the use of opioids and other pain treatments, to an evaluation of the association between regulatory drug safety advisories and changes in drug use. A full posting of abstracts/summaries of these articles may be found on our website.

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