Pharmaceuticals - Bill of Health

Regulating the Medication Gatekeepers: The Need for Federal PBM Reform

December 3, 2024December 5, 2024 The Petrie-Flom Center Staff Leave a comment

On September 20, the Federal Trade Commission (FTC) filed a landmark lawsuit against the three largest prescription drug benefit managers (PBMs) — Caremark Rx, Express Scripts, and OptumRx — and their affiliated group purchasing organizations. The FTC alleges that these entities engaged in “anticompetitive and unfair rebating practices,” artificially increasing insulin drug prices and shifting costs to vulnerable patients.

This litigation is not an isolated case, but rather represents a broader effort by federal agencies and lawmakers to curb the power of PBMs and reduce drug costs. This article explores the role of PBMs in the health care system and potential next steps for federal reform.

Unseen Scars: The Devastating Impact of Corruption on Mental Health Systems in Low and Middle-Income Countries

July 11, 2024July 12, 2024 The Petrie-Flom Center Staff Leave a comment

by Daniela Cepeda Cuadrado

There is a wealth of research demonstrating that corruption — the abuse of entrusted power for private gain — has contributed to weakening health systems and worsening public health globally. Corruption is associated with a higher infant mortality rate, the rise of antimicrobial resistance, and the diversion of key resources to invest in strengthening health systems. Corruption’s impact on health systems is well documented – that is if we see health systems only as the structures in place to cater to people’s physical health needs.

five multi ethnic business people negotiating in modern boardroom.

A Pseudo-Nonprofit Model for Psychedelic Clinical Trial Funding

October 25, 2023October 25, 2023 Vincent Joralemon Leave a comment

By Vincent Joralemon

A $70 million deal struck between a venture capital firm and a prominent psychedelic advocacy organization suggests that funding for psychedelic research may increasingly rely on nonprofit and commercial partnerships.

As the commercial appeal of these substances grows, this might serve as a promising model to channel the resources of for-profit entities toward this field. This funding can support clinical trials, FDA approval, and ultimately insurance coverage for these promising (but resource-intensive) therapies.

Hundred dollar bills rolled up in a pill bottle

Reasonable Pricing Clauses: A First Step Toward Ensuring Taxpayers a Fair Return on their Public R&D Investment

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

By Nikhil Chaudhry and Reshma Ramachandran

Earlier this month, the Department of Health and Human Services announced that it had successfully included a reasonable pricing provision in a $326M investment contract with Regeneron for development of a next generation monoclonal antibody therapy for COVID-19. This was the first time the Biden Administration had included such a provision as part of its research funding agreements with the private sector, demonstrating that it is indeed possible for the federal government to negotiate deals with pharmaceutical companies that ensure that products developed with public dollars are priced comparably to the global market.

white pills spilling out of orange plastic pill bottle onto hundred dollar bills.

Merck Price Negotiation Lawsuit May Face Same Obstacles as 340B Takings Claims

June 15, 2023June 15, 2023 Laura Dolbow Leave a comment

By Laura Dolbow

Merck recently filed a lawsuit that challenges the constitutionality of the Medicare price negotiation program created by the Inflation Reduction Act. Under this program, HHS will select a small number of single source drugs for price negotiation. Merck alleges that the price negotiation program operates as a price control because it effectively requires manufacturers to accept the maximum fair price as a condition of participation in Medicare and Medicaid. Merck argues that this form of price regulation charts a “radical new course” for Medicare that violates the Takings Clause of the Fifth Amendment.

But the price negotiation program is not the first time that Congress has placed a restriction on the prices that Medicare program participants can charge. And Merck’s lawsuit is not the first suit that has alleged that such price regulations are unconstitutional takings. Drug manufacturers recently made similar claims in litigation involving the 340B Drug Pricing Program. Two district courts rejected those claims, highlighting several obstacles that Merck’s takings claim may face as well.

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

March 20, 2023March 8, 2023 Matthew Chun Leave a comment

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.

Person in protective yellow hazmat suit and mask holds pills in hands.

Book Review: ‘The Truth Pill: The Myth of Drug Regulation in India’

November 18, 2022November 17, 2022 Aparajita Lath Leave a comment

By Aparajita Lath

The Truth Pill, authored by Dinesh Thakur and Prashant Reddy, is a monumental work that convincingly shows that drug regulation is but a myth in India.

In their investigative style, the authors explain drug regulation in India through the lens of history, both Indian and global. The book’s combination of history and contemporary issues makes for an immersive and compelling read. It may, however, leave you feeling frightened, given the dysfunctional regulatory system in India and the impact this can have on patients around the world. However, the book not only highlights problems but also offers several well-thought-out and actionable paths to reform.

Businessman's hands typing on laptop keyboard in morning light

Microdosing at Work: Business and Legal Implications

April 8, 2022April 8, 2022 The Petrie-Flom Center Staff Leave a comment

By Vincent Sliwoski

In light of the widespread cultural and business culture adoption of microdosing, private sector employers should reconsider the implications of a blanket prohibition on workplace use of controlled substances.

Microdosing is the practice of ingesting subperceptual amounts of psychedelic drugs, such as psilocybin mushrooms or LSD. People microdose for a variety of reasons. These may include medical reasons, such as the treatment of anxiety, depression or attention disorders; or they may include “performance” reasons, like attempts to increase productivity, creativity or awareness.

Placebo Effect vector illustration blue.

Is Microdosing Just Placebo?

April 7, 2022April 7, 2022 The Petrie-Flom Center Staff Leave a comment

By Vince Polito

People who microdose psychedelics claim that it provides a very wide range of benefits, from improvements in mood, to reduced substance use, to cognitive enhancement.

But is microdosing really delivering all of those benefits? Or is it just a placebo effect?

Introducing Affiliated Researchers for the Project on Psychedelics Law and Regulation