Vaccines - Bill of Health

Medical Development Laboratory: Caucasian Female Scientist Looking Under Microscope, Analyzes Petri Dish Sample. Specialists Working on Medicine, Biotechnology Research in Advanced Pharma Lab.

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

April 21, 2023April 19, 2023 Ameet Sarpatwari Leave a comment

By Ameet Sarpatwari, Alexander Egilman, 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 March. The selections feature topics ranging from an analysis of patent challenges by generic manufacturers on brand-name inhalers, a discussion of the Alliance for Hippocratic Medicine v. FDA lawsuit and its potential implications for pharmaceutical regulation, and an estimate of U.S. public investment in the development of mRNA COVID-19 vaccines. A full posting of abstracts/summaries of these articles may be found on our website.

Buenos Aires, Argentina, March 4, 2021. People waiting for their turn to be vaccinated against Covid-19 at the Club Atlético River Plate Microstadium.

Considerations from Argentina on the Judicial Control of Public Health Policies

April 14, 2023April 14, 2023 The Petrie-Flom Center Staff Leave a comment

By María Natalia Echegoyemberry and Francisco Verbic

This article looks at the COVID-19 pandemic response in Argentina, with a particular focus on the judicial control of public health policies. Looking ahead, we discuss the mechanisms that need to be implemented in order to avoid undue judicial interference, which is particularly critical in countries like Argentina, where the Judiciary is delegitimized and strongly questioned.

We focus on a case in Argentina where a federal judge ordered the suspension of the campaign for pediatric vaccination against COVID-19.

Bill of Health - silhouette of COVID-19 vaccine vile held in front of company logos, cooperation and antitrust in vaccine production

Unlocking the mRNA Platform Technology: Walking the Talk with Investment Protection

April 7, 2023April 7, 2023 Aparajita Lath Leave a comment

By Aparajita Lath

Two articles published last month in the BMJ analyze the public investment and financing of mRNA COVID-19 vaccines, highlighting the extensive government funding that has supported the development of mRNA technology from 1985 to 2022.

However, rewards from these government investments are going back into the hands of pharma corporations and shareholders, with little thought given to public needs.

Together, these articles underscore the injustice of the present moment and emphasize the need to reform intellectual property protections for government-funded inventions of public health significance.

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

March 27, 2023March 27, 2023 Jennifer S. Bard Leave a comment

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.

Improving the Future of Public Health by Applauding Appropriate Judicial Oversight

March 2, 2023February 28, 2023 The Petrie-Flom Center Staff Leave a comment

By Marshall B. Kapp

During the COVID-19 pandemic, the Public Health Establishment (PHE)/legal enterprise collaborative fell short of constitutional standards in a number of situations, resulting in adverse judicial rulings of which the PHE and its like-minded academic advocates now complain.

This unhappiness with judicial oversight is an opportunity for introspection. Rather than blaming nefarious or deplorable other forces, a better approach to rehabilitating and enhancing public health law in the future lies instead in the PHE taking stock of itself and committing to a more open-minded, humility infused, and objective approach to the definition of science, the role of expertise, and the better targeted and clearly justified employment of legal force in the next major public health emergency context.

Playing the Long Game for Public Health Law

March 1, 2023February 27, 2023 The Petrie-Flom Center Staff Leave a comment

By Lance Gable

At the start of 2023, public health law in the United States faces two obvious structural shortcomings that need to be addressed: the inadequate fit between public health emergency powers and longer-lasting emergencies, and the increased susceptibility of public health law to dilution through political and judicial action.

President Joe Biden at desk in Oval Office.

Federalizing Public Health

February 28, 2023February 27, 2023 The Petrie-Flom Center Staff Leave a comment

By Elizabeth Weeks

The most promising path forward in public health is to continue recognizing federal authority and responsibility in this space. I carefully choose “recognizing,” rather than “expanding” or “moving” because it is critical to the argument that federal authority for public health already exists within the federalist structure and that employing federal authority to address public health problems does not represent a dimunition of state authority. Rather than a pie, of which pieces consumed at the federal level necessarily reduce pieces consumable at the state level, we should envision the relationship as a Venn diagram, where increasing overlap strengthens authority for promoting and protecting public health broadly.

The United States Capitol building at sunset at night in Washington DC, USA

The End of Public Health? It’s Not Dead Yet

February 27, 2023February 24, 2023 The Petrie-Flom Center Staff Leave a comment

By Nicole Huberfeld

Once again, health law has become a vehicle for constitutional change, with courts hollowing federal and state public health authority while also generating new challenges. In part, this pattern is occurring because the New Roberts Court — the post-Ruth Bader Ginsburg composition of U.S. Supreme Court justices — is led by jurists who rely on “clear statement rules.” This statutory interpretation canon demands Congress draft textually unambiguous laws and contains a presumption against broadly-worded statutes that are meant to be adaptable over time. In effect, Congress should leave nothing to the imagination of those responsible for implementing federal laws, i.e., executive agencies and state officials, so everything a statute covers must be specified, with no room for legislative history or other non-textual sources.

Lawyer working with agreement in office. man signing hand writing pen attorney concept.

Strategic Maneuvers in Response to COVID-19 Denialist Laws and Policies

February 23, 2023February 23, 2023 The Petrie-Flom Center Staff Leave a comment

By James G. Hodge, Jr.

Over the course of the COVID-19 pandemic, now entering its fourth year in 2023, legislators, executives, and judges at every level of government have sought measures to derail efficacious public health interventions. Despite clear risks of excess morbidity and mortality, these law- and policy-makers, often in more conservative jurisdictions, intentionally chose to push laws, guidance, and decisions prioritizing rapid “returns to normalcy” over the health and lives of Americans.

Casual observers of these collective trends may see the end of public health powers and services as we know them in the United States. And that’s where they are wrong.

New York NY USA-August 17, 2021 Businesses in Chelsea in New York display signs requiring proof of vaccination prior to entering.

Employers and the Future of Public Health

February 22, 2023February 21, 2023 The Petrie-Flom Center Staff Leave a comment

By Sharona Hoffman

As state and federal public health authority erodes, employers may increasingly find themselves playing a central role in promoting public health. For example, during the COVID-19 pandemic, many employers either incentivized or required employees and customers to be vaccinated and/or masked even in the absence of federal and state mandates. In the future, they may frequently take the lead in implementing public health measures.

Category: Vaccines